Consumer medicine information

Vaxneuvance

Pneumococcal 15 valent polysaccharide conjugate vaccine

BRAND INFORMATION

Brand name

Vaxneuvance

Active ingredient

Pneumococcal 15 valent polysaccharide conjugate vaccine

Schedule

SUMMARY CMI

VAXNEUVANCE^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this vaccine, speak to your doctor, nurse or pharmacist.

▼ This vaccine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I being given VAXNEUVANCE?

VAXNEUVANCE is a vaccine given to help protect you or your child against pneumococcal disease caused by 15 types of bacteria called Streptococcus pneumoniae or pneumococcus. VAXNEUVANCE can be given to adults and children 6 weeks of age and older.

For more information, see Section 1. Why am I being given VAXNEUVANCE? in the full CMI.

2. What should I know before I am given VAXNEUVANCE?

Do not get VAXNEUVANCE if you or your child are allergic to any of the ingredients in VAXNEUVANCE listed at the end of the CMI, or to any vaccines containing diphtheria toxoid.

Talk to your doctor if you or your child have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I am given VAXNEUVANCE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VAXNEUVANCE and affect how it works. Tell your doctor, nurse or pharmacist if you or your child are taking, have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription. For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How is VAXNEUVANCE given?

A doctor or nurse will give you or your child this vaccine as an injection into the muscle (preferably in the upper arm or thigh for children and the upper arm for adults). More instructions can be found in Section 4. How is VAXNEUVANCE given? in the full CMI.

5. What should I know after being given VAXNEUVANCE?

Things you should do	Call your doctor straight away if you or your child have symptoms of an allergic reaction, which may include wheezing or trouble breathing, swelling of the face, lips or tongue, hives or rash. Remind any doctor, nurse or pharmacist you visit that you or your child have been given VAXNEUVANCE.
Driving or using machines	VAXNEUVANCE is not likely to affect the ability to drive or use machines.
Looking after your vaccine	It is unlikely that you will be asked to store VAXNEUVANCE. If you are, keep this vaccine in the refrigerator between 2°C and 8°C. Do not freeze this vaccine. Keep this vaccine in the original pack until it is time to be given.

For more information, see Section 5. What should I know after being given VAXNEUVANCE? in the full CMI.

6. Are there any side effects?

The most common side effects for infants and toddlers are pain, swelling, redness or a lump where your child had the injection, being more fussy than usual, being more sleepy than usual, eating less than usual, and fever. The most common side effects for children (2 through 17 years of age) are pain, swelling or redness or a lump where your child had the injection, muscle aches, feeling tired, headache and fever. The most common side effects for adults are pain, swelling or redness where you had the injection, feeling tired, muscle aches, headache and joint pain. These side effects are generally mild and last a short time.

For more information, including what to do if you or your child have any side effects, see Section 6. Are there any side effects? in the full CMI.

▼ This vaccine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

FULL CMI

VAXNEUVANCE^®

Active ingredient(s): Pneumococcal 15-valent Conjugate Vaccine [CRM197 Protein], adsorbed

Consumer Medicine Information (CMI)

This leaflet provides important information about getting VAXNEUVANCE. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about getting VAXNEUVANCE.

This vaccine can be given to adults and children so you may be reading this leaflet for you or for your child.

Where to find information in this leaflet:

1. Why am I being given VAXNEUVANCE?
2. What should I know before I am given VAXNEUVANCE?
3. What if I am taking other medicines?
4. How is VAXNEUVANCE given?
5. What should I know after being given VAXNEUVANCE?
6. Are there any side effects?
7. Product details

1. Why am I being given VAXNEUVANCE?

VAXNEUVANCE is a vaccine given to help protect you or your child against pneumococcal disease caused by 15 types of bacteria called Streptococcus pneumoniae or pneumococcus. VAXNEUVANCE can be administered to adults and children 6 weeks of age and older.

Pneumococcal disease refers to any illness caused by pneumococcus. These bacteria can cause many types of illnesses including lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis), and a severe infection in the blood (bacteraemia). These illnesses are more likely to occur in younger children, older adults and people with certain diseases or behaviors such as cigarette smoking. In children, pneumococcus is also one of the common causes of ear infections.

VAXNEUVANCE may not protect against diseases caused by types of pneumococcus that are not covered by the vaccine.

2. What should I know before I am given VAXNEUVANCE?

Warnings

Do not get VAXNEUVANCE if:

You or your child are allergic to any of the ingredients in VAXNEUVANCE listed at the end of this leaflet, or to any vaccine containing diphtheria toxoid.
Always check the ingredients to make sure you or your child can be given this vaccine.

Check with your doctor if you or your child:

Have or have had any other medical conditions or any allergies.
Have a weak immune system (which means the body is less able to fight off infections) or are taking certain medicines that may make the immune system weak (for example, immunosuppressants or steroids).

If your child is an infant, also tell your healthcare provider if your child was born prematurely (too early).

As with other vaccines, VAXNEUVANCE may not fully protect all those who get it.

You may obtain further information from your doctor, nurse or pharmacist, who has more detailed information.

After being given VAXNEUVANCE, you or your child may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you or your child are pregnant or intend to become pregnant. They will tell you if you should receive VAXNEUVANCE.

Talk to your doctor if you or your child are breastfeeding or intend to breastfeed. They will tell you if you should receive VAXNEUVANCE.

Children

It has not yet been established whether VAXNEUVANCE can be given to children younger than 6 weeks of age.

3. What if I am taking other medicines?

Your child can be given VAXNEUVANCE at the same time as other routine childhood vaccines.

In adults, VAXNEUVANCE can be given at the same time as flu (inactivated influenza) vaccine.

Tell your doctor, nurse or pharmacist if you or your child are taking, have recently taken or might take any other vaccines or medicines (for example, immunosuppressants or steroids which may make the immune system weak), including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor, nurse or pharmacist if you are not sure about what medicines, vitamins or supplements you or your child are taking and if these affect VAXNEUVANCE.

4. How is VAXNEUVANCE given?

How VAXNEUVANCE is given

A doctor or nurse will give you or your child this vaccine as an injection into the muscle (preferably in the upper arm or thigh for children and the upper arm for adults).
Other vaccines may be given at the same time, but at a different site.

How many injections will be given

Infants may receive up to 3 doses of the vaccine through 6 months of age based on official recommendations. An additional dose is given to toddlers between 11 through 15 months of age. Your healthcare provider will tell you when your child should receive their next dose.
If your child did not receive all doses according to official recommendations, your healthcare provider may recommend doses to help them catch up.
Adults need one dose of the vaccine.
People with certain medical conditions may need more than one dose of VAXNEUVANCE. Talk to your doctor, nurse or pharmacist about how many doses you or your child should receive.

5. What should I know after being given VAXNEUVANCE?

Things you should do

Call your doctor straight away if you or your child:

Have symptoms of an allergic reaction, which may include wheezing or trouble breathing, swelling of the face, lips or tongue, hives or rash.

Remind any doctor, nurse or pharmacist you visit that you or your child have been given VAXNEUVANCE.

Driving or using machines

VAXNEUVANCE is not likely to affect the ability to drive or use machines.

Looking after your vaccine

It is unlikely that you will be asked to store VAXNEUVANCE. If you are:

Keep this vaccine in the refrigerator at a temperature between 2°C and 8°C.
Do not freeze this vaccine.
Keep this vaccine in the original pack until it is time to be given.

Keep it where young children cannot reach it.

Getting rid of any unwanted vaccine

It is unlikely that you will be asked to dispose of VAXNEUVANCE. However, if you no longer need this vaccine or it is out of date, take it to any pharmacy for safe disposal.

Do not get this vaccine after the expiry date.

6. Are there any side effects?

All medicines, including vaccines, can have side effects. If you or your child do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Infants and Toddlers:

Pain, swelling, redness or a lump where your child had the injection
Being more fussy than usual
Being more sleepy than usual
Eating less than usual
Fever

Children 2 through 17 years of age

Pain, swelling, redness or a lump where your child had the injection
Muscle aches
Feeling tired
Headache
Fever

Adults 18 years of age and older

Pain, swelling or redness where you had the injection
Feeling tired
Muscle aches
Headache
Joint pain

These are the most common side effects and are generally mild and last a short time.

Speak to your doctor if you or your child have any of these less serious side effects and they worry you.

Serious side effects

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you or your child feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you or your child experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this vaccine.

7. Product details

This vaccine is only available with a doctor's prescription.

What VAXNEUVANCE contains

Active ingredient (main ingredient)	Bacterial sugars from 15 types of pneumococcus each linked to a protein (CRM197)* as the active ingredient, adsorbed on aluminium (as aluminium phosphate adjuvant^).
Other ingredients	Sodium chloride Histidine Polysorbate 20 Water for injections

*The sugars from these bacteria and the protein are not alive and do not cause disease.

^The adjuvant is included to help the vaccine work better.

VAXNEUVANCE does not contain any preservatives.

Do not get this vaccine if you or your child are allergic to any of these ingredients.

What VAXNEUVANCE looks like

VAXNEUVANCE is an opalescent suspension for injection.

VAXNEUVANCE is available as a prefilled syringe (AUST R 350791).

The tip cap and plunger stopper of the pre-filled syringe are not made with natural rubber latex.

Who distributes VAXNEUVANCE

Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113

CCPPI-V114-I-072022

RCN: 000024490-AU

This leaflet was prepared in October 2024.

Published by MIMS January 2025

BRAND INFORMATION

Brand name

Vaxneuvance

Active ingredient

Pneumococcal 15 valent polysaccharide conjugate vaccine

Schedule

1 Name of Medicine

Vaxneuvance (pneumococcal 15-valent conjugate vaccine [CRM₁₉₇ protein], adsorbed).

2 Qualitative and Quantitative Composition

Each 0.5 mL dose contains 32 micrograms of total pneumococcal purified capsular polysaccharide (2.0 micrograms each of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4.0 micrograms of serotype 6B) conjugated to 30 micrograms of non-toxic diphtheria CRM₁₉₇ protein, adsorbed on 125 micrograms of aluminium (as aluminium phosphate adjuvant).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Vaxneuvance is a suspension for injection available in 0.5 mL single-dose prefilled syringes.
The vaccine is an opalescent suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Vaxneuvance is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) in adults and children from 6 weeks of age.
Vaxneuvance may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.
The use of Vaxneuvance should be guided by official recommendations.

4.2 Dose and Method of Administration

The vaccination schedule for Vaxneuvance should be based on official recommendations.

Dosage (dose and interval).

Administer a 0.5 mL dose of Vaxneuvance intramuscularly.

Paediatrics.

Routine vaccination schedule for infants and toddlers.

3 Dose regimen (two dose primary series followed by a toddler dose).

The vaccination regimen consists of 3 doses of Vaxneuvance, with the first dose given as early as 6 weeks of age, and a second dose administered 8 weeks later. The third dose should be administered at approximately 11 through 15 months of age.

4 Dose regimen (three dose primary series followed by a toddler dose).

The vaccination regimen consists of 4 doses of Vaxneuvance, with the first dose given as early as 6 to 12 weeks of age, with an interval of 4 to 8 weeks between doses in the primary series. The fourth dose should be administered at approximately 11 through 15 months of age and at least 2 months after the third dose.
Preterm infants. Preterm infants (< 37 weeks gestation at birth) should receive a 4-dose regimen (three dose primary series followed by a toddler dose) of Vaxneuvance, with the first dose given as early as 6 to 12 weeks of age, with an interval of 4 to 8 weeks between doses in the primary series. The fourth dose should be administered at approximately 11 through 15 months of age and at least 2 months after the third dose. [See Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects); Section 5.1 Pharmacodynamic Properties, Clinical trials].
Prior vaccination with another pneumococcal conjugate vaccine. The vaccination regimen can be completed with Vaxneuvance if initiated with another pneumococcal conjugate vaccine [see Section 5.1 Pharmacodynamic Properties, Clinical trials].
Catch up vaccination schedule for children 7 months through 17 years of age. For children 7 months through 17 years of age who are pneumococcal vaccine naïve or not fully vaccinated or completed a dosing regimen with lower valency pneumococcal conjugate vaccines, the following catchup schedule should be considered:

Infants 7 through 11 months of age.

Three doses, with the first two doses given at least 4 weeks apart. The third dose is given after 12 months of age, separated from the second dose by at least 2 months.

Children 12 through 23 months of age.

Two doses, with an interval of 2 months between doses.

Children and adolescents 2 through 17 years of age.

One single dose.
If a previous pneumococcal conjugate vaccine was administered, at least 2 months should elapse before receiving Vaxneuvance.

Adults.

One single dose.

Special populations.

The dosing schedule of Vaxneuvance in special populations should be guided by official recommendations.

Method of administration.

For intramuscular use only. Do not inject intravascularly.
The preferred site for injection is the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children and adults. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.

Instruction for use.

Vaxneuvance should not be diluted or mixed with other vaccines.
The full recommended dose of the vaccine should be used.
When Vaxneuvance is administered at the same time as another injectable vaccine(s), the vaccines should always be given at different injection sites [see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions].
Because this product is a suspension containing an adjuvant, hold horizontally and shake vigorously immediately prior to use to obtain an opalescent suspension in the vaccine container. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. This product should not be used if particulate matter or discoloration is found.
The prefilled syringe is for single use only and should not be used for more than one individual. Attach a needle by twisting in a clockwise direction until the needle fits securely on the syringe. Inject the entire contents of the syringe. Exercise caution to avoid harm from an accidental needle stick.

4.3 Contraindications

Vaxneuvance is contraindicated in individuals with a history of a severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine or any diphtheria toxoid-containing vaccine [see Section 2 Qualitative and Quantitative Composition; Section 6.1 List of Excipients].

4.4 Special Warnings and Precautions for Use

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to Vaxneuvance [see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions].
The potential risk of apnoea should be considered when administering any intramuscular vaccine to infants born prematurely. As the benefit of vaccination is high in this group of infants, vaccination generally should not be withheld or delayed.
As with any vaccine, Vaxneuvance may not protect all vaccine recipients.

Use in the elderly.

Of the 4,344 individuals aged 50 years and older who received Vaxneuvance, 2,470 (56.9%) were 65 years and older, and 479 (11.0%) were 75 years and older [see Section 4.8 Adverse Effects (Undesirable Effects); Section 5 Pharmacological Properties, Clinical trials].

Paediatric use.

The safety and effectiveness of Vaxneuvance in children younger than 6 weeks of age have not been established.

Effects on laboratory tests.

Not applicable.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Use with other vaccines.

Infants and children less than 2 years of age.

Vaxneuvance can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, pertussis, poliomyelitis (serotypes 1, 2 and 3), hepatitis A, hepatitis B, Haemophilus influenzae type b, measles, mumps, rubella, varicella and rotavirus vaccine [see Section 4.8 Adverse Effects (Undesirable Effects); Section 5 Pharmacological Properties, Concomitant vaccination].
Concomitant administration of Vaxneuvance with meningococcal ACWY and meningococcal B vaccines has not been studied.

Children and adolescents 2 through 17 years of age.

There are no data on the concomitant administration of Vaxneuvance with other vaccines.

Adults.

Vaxneuvance can be administered concomitantly with inactivated influenza vaccine [see Section 4.8 Adverse Effects (Undesirable Effects); Section 5 Pharmacological Properties, Clinical trials]. There are no data on the concomitant administration of Vaxneuvance with other vaccines.

Use with immunosuppressive therapies.

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids, therapeutic proteins and targeted immunomodulators may reduce the immune responses to vaccines [see Section 4.4 Special Warnings and Precautions for Use].

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Vaxneuvance administered to female rats at a dose approximately 200 times the adult human dose on a microgram/kg basis had no effects on mating performance, fertility or embryonic/fetal survival.
(Category B1)

Animal data.

Developmental and reproductive toxicity studies have been performed in female rats at a dose approximately 200 times the adult human dose on a microgram/kg basis. In these studies, female rats received Vaxneuvance (32 micrograms/rat/dose) by intramuscular injection 28 days and 7 days prior to mating, on gestation day 6 and on lactation day 7. There was no evidence of embryofetal lethality or fetal malformations and variations and no adverse effects on pre-weaning development were observed. Antibodies to all 15 serotypes contained in Vaxneuvance were detected in offspring, attributable to the acquisition of maternal antibodies via placental transfer during gestation and possibly via lactation.

Human data.

There are no adequate and well-controlled studies of Vaxneuvance in pregnant women, and human data available from clinical trials with Vaxneuvance have not established the presence or absence of vaccine-associated risk during pregnancy. The decision to vaccinate a woman who is pregnant should consider the woman's risk of exposure to S. pneumoniae; Vaxneuvance should be administered only if clearly needed.
It is not known whether this vaccine is excreted in human milk.
Vaccine-specific antibodies were detected in rat offspring via maternal transfer from immunised female rats [see Use in pregnancy]. Evaluation of antibody levels in animal milk was not conducted.

4.7 Effects on Ability to Drive and Use Machines

Vaxneuvance has no, or negligible, influence on the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials experience.

Children 6 weeks through 17 years of age.

Infants and toddlers receiving a routine vaccination schedule. The safety of Vaxneuvance in healthy infants (from 6 weeks of age at first vaccination) and toddlers (11 months through 15 months of age) was assessed in 5 randomised, double-blind, active comparator controlled clinical studies (Protocol 008, Protocol 025, Protocol 027, Protocol 029 and Protocol 031) of 7,229 participants conducted across the Americas, Europe, and Asia Pacific. In four of these studies (Protocol 008, Protocol 027, Protocol 029 and Protocol 031), the safety of Vaxneuvance was evaluated when administered as a 4-dose regimen given at 2, 4, 6 and 12 through 15 months of age. A fifth study (Protocol 025) evaluated the safety of Vaxneuvance when administered as a 3-dose regimen given at 2, 4 and 11 through 15 months of age. All 5 studies evaluated the safety of Vaxneuvance when administered concomitantly with other routine paediatric vaccinations [see Section 5 Pharmacological Properties, Clinical trials]. Protocol 027 also evaluated the safety of mixed 4-dose regimens in participants who completed the regimen with Vaxneuvance after receiving one or more doses of Prevenar 13 [Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed]. Additionally, four of these studies evaluated safety in preterm infants (< 37 weeks gestation at birth) [see Section 5 Pharmacological Properties, Clinical trials]. Across all 5 studies, 4,286 participants received a complete regimen of Vaxneuvance, 2,405 participants received a complete regimen of Prevenar 13 and 538 participants received a mixed regimen.
Safety was evaluated using a Vaccination Report Card for up to 14 days postvaccination. Injection-site adverse events and systemic adverse events were solicited on Day 1 through Day 14 postvaccination. Body temperature was solicited on Day 1 through Day 7 postvaccination. Unsolicited adverse events were reported on Day 1 through Day 14 postvaccination. The duration of the safety follow-up period following the last vaccination with Vaxneuvance was 1 month in Protocol 008 and 6 months in Protocol 025, Protocol 027, Protocol 029 and Protocol 031.

Solicited adverse reactions in infants and toddlers receiving a routine vaccination schedule.

The percentage of infants (preterm and term) and toddlers with solicited adverse reactions that occurred within 14 days following administration of Vaxneuvance or Prevenar 13 based on pooled data from four studies (excluding mixed 4-dose regimens) are shown in Tables 1 and 2. The majority of solicited adverse reactions were mild to moderate (based on intensity or size) and of short duration (≤ 3 days). Severe reactions (defined as being extremely distressed or unable to do usual activities or size > 7.6 cm) occurred in ≤ 1.3% of infants and toddlers following each dose, with the exception of irritability, which occurred in ≤ 5.2% of the participants.

Unsolicited adverse reactions in infants and toddlers receiving a routine vaccination schedule.

Injection-site urticaria occurred in up to 0.3% of infants and toddlers following each dose of Vaxneuvance.

Safety with concomitant administration in infants and toddlers.

The safety profile was similar when other routine paediatric vaccines were administered concomitantly with Vaxneuvance or Prevenar 13 [see Section 5 Pharmacological Properties, Clinical trials].

Safety of a mixed dose regimen of different pneumococcal conjugate vaccines.

The safety profiles of mixed 4-dose regimens of Vaxneuvance and Prevenar 13 were generally comparable to those of complete 4-dose regimens of either Vaxneuvance or Prevenar 13 [see Section 5 Pharmacological Properties, Clinical trials].
Infants, children and adolescents receiving a catch-up vaccination schedule. The safety of Vaxneuvance in healthy infants, children and adolescents from 7 months through 17 years of age was assessed in a double-blind, active comparator-controlled clinical study (Protocol 024) in which 606 participants were randomised to receive 1 to 3 doses of Vaxneuvance or Prevenar 13, depending on age at enrollment. All infants and children less than 2 years of age were pneumococcal vaccine-naïve. Among children and adolescents from 2 through 17 years of age (N=352), 42.9% had a history of previous vaccination with a lower-valency pneumococcal conjugate vaccine. The safety assessment was consistent with that used in the studies evaluating a routine vaccination schedule. The duration of the safety follow-up period following the last study vaccination within each age cohort was 6 months.

Solicited adverse reactions in infants, children and adolescents receiving a catch-up vaccination schedule.

The percentage of participants with solicited adverse reactions that occurred within 14 days following administration of Vaxneuvance or Prevenar 13 within each age cohort are shown in Tables 3, 4 and 5. The majority of solicited adverse reactions were mild to moderate (based on intensity or size) and of short duration (≤ 3 days). Severe reactions (defined as being extremely distressed or unable to do usual activities or size > 7.6 cm) occurred in ≤ 1.6% of infants and children 7 months through 23 months of age following each dose, and ≤ 4.5% of children and adolescents 2 through 17 years of age.

Adults 18 years of age and older.

The safety of Vaxneuvance in healthy and immunocompetent adults was assessed in 6 randomised, double-blind clinical studies (Protocol 007, Protocol 016, Protocol 017, Protocol 019, Protocol 020 and Protocol 021) conducted across the Americas, Europe and Asia Pacific, which included 7,136 adults ranging in age from 18 to 98 years. Each study enrolled adults with stable underlying medical conditions and/or risk factors that are known to increase the risk of pneumococcal disease.
Vaxneuvance was administered to 5,478 adults; 1,134 were 18 to 49 years of age, 1,874 were 50 to 64 years of age, and 2,470 were 65 years of age and older. Of those who received Vaxneuvance, 5,101 adults were pneumococcal vaccine naïve and 377 adults were previously vaccinated with Pneumovax 23 [pneumococcal vaccine polyvalent] at least 1 year prior to enrollment.
The safety of Vaxneuvance in pneumococcal vaccine-naïve adults 50 years of age and older was evaluated in 3 active comparator-controlled clinical studies (Protocol 016, Protocol 019 and Protocol 020) in which 3,032 participants received Vaxneuvance and 1,154 participants received Prevenar 13 (PCV13). A descriptive study (Protocol 017) evaluated the safety of Vaxneuvance in pneumococcal vaccine-naïve adults 18 to 49 years of age.
The safety of Vaxneuvance in adults 65 years of age and older who were previously vaccinated with Pneumovax 23 (at least 1 year prior to study entry) was evaluated in an additional descriptive study (Protocol 007).
The safety of concomitant administration of Vaxneuvance with seasonal inactivated influenza vaccine was evaluated in 1,196 adults 50 years of age and older, including those with or without a history of prior vaccination with Pneumovax 23 (Protocol 021).
Safety was evaluated using a vaccination report card for up to 14 days postvaccination. Oral body temperature and injection site adverse events were solicited on day 1 through day 5 postvaccination. Systemic adverse events were solicited on day 1 through day 14 postvaccination. Unsolicited adverse events were reported on day 1 through day 14 postvaccination. The duration of the safety follow-up period postvaccination with Vaxneuvance was 1 month in Protocol 007, 6 months in Protocol 019, Protocol 020, Protocol 017 and Protocol 021 and 12 months in Protocol 016.

Solicited adverse reactions.

The percentage of participants with solicited adverse reactions that occurred within 5 or 14 days following administration of Vaxneuvance or Prevenar 13 in 5 studies are shown in Tables 6-7. All solicited adverse reactions occurred in ≥ 5% of participants with Vaxneuvance; older adults reported fewer solicited adverse reactions than younger adults, regardless of vaccination group. The majority of solicited adverse reactions were mild (based on intensity or size) and of short duration (≤ 3 days); severe reactions (defined as an event that prevents normal daily activity or size > 10 cm) occurred in ≤ 1.5% of adults.

Unsolicited adverse reactions.

Injection site pruritus occurred in 1.0% to 2.8% of pneumococcal vaccine-naïve adults vaccinated with Vaxneuvance.

Additional information in special populations.

Populations at increased risk for pneumococcal disease.

Infants born prematurely.

The safety of Vaxneuvance was evaluated in preterm infants (< 37 weeks gestation at birth) enrolled within 4 clinical studies (Protocol 025, Protocol 027, Protocol 029 and Protocol 031) in which these participants received 4 doses of Vaxneuvance. The safety profile in preterm infants was generally consistent with the safety profile observed in the overall healthy infant population in these studies (including preterm and term infants).

Children with sickle cell disease.

In children with sickle cell disease (Protocol 023), the safety profile of Vaxneuvance was generally consistent with its safety profile in healthy children.

Individuals living with HIV.

Children living with HIV.

In children living with HIV (Protocol 030), the safety profile of Vaxneuvance was generally consistent with its safety profile in healthy children.

Adults living with HIV.

In adults living with HIV (Protocol 018), the safety profile of Vaxneuvance was generally consistent with its safety profile in immunocompetent pneumococcal vaccine-naïve adults.

Individuals with haematopoietic stem cell transplant.

Safety was assessed in 131 adults and 8 children ≥ 3 years of age who had received an allogeneic haematopoietic stem cell transplant (allo-HSCT) 3 to 6 months prior to enrolment, all of whom received between 1 and 4 doses of Vaxneuvance. The safety profile of Vaxneuvance in recipients of allo-HSCT was generally consistent with the safety profile in a healthy population.

Adults with chronic conditions and other risk factors.

In adults 18 to 49 years of age with 1 risk factor or 2 or more risk factors for pneumococcal disease (Protocol 017), the safety profile of Vaxneuvance was generally consistent with its safety profile in the overall study population.

Safety with concomitant influenza vaccine administration.

The safety profile of Vaxneuvance when administered concomitantly with inactivated influenza vaccine was generally consistent with the safety profile of Vaxneuvance.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

There are no data with regard to overdose.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Vaxneuvance contains serotype specific pneumococcal capsular polysaccharides each of which is conjugated to a carrier protein (CRM₁₉₇), and elicits antibodies that enhance opsonisation, phagocytosis, and killing of pneumococci to protect against pneumococcal disease. Vaxneuvance is also expected to elicit a T-cell dependent immune response. Carrier protein-specific helper T-cells support specificity, functionality and maturation of serotype specific B cells.
Immune responses following natural exposure to S. pneumoniae or following pneumococcal vaccination can be determined through the measurements of opsonophagocytic activity (OPA) and immunoglobulin G (IgG) responses. OPA represents functional antibodies capable of opsonising pneumococcal capsular polysaccharides for presentation to phagocytic cells for engulfment and subsequent killing and are considered an important immunologic surrogate measure of protection against pneumococcal disease in adults. OPA titers are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. Serotype-specific immune responses (OPA and IgG) for the 15 serotypes contained in Vaxneuvance were measured using a validated multiplexed opsonophagocytic assay (MOPA) and a validated pneumococcal electrochemiluminescence (Pn ECL) assay, bridged to the WHO reference enzyme linked immunosorbent assay (ELISA). In children, a serotype-specific IgG antibody level corresponding to ≥ 0.35 microgram/mL using the WHO ELISA has been used as the threshold value for the clinical evaluation of pneumococcal conjugate vaccines.

Burden of disease.

Pneumococcal disease is associated with significant morbidity and mortality in both children and adults worldwide. Although all age groups may be affected by pneumococcal disease, the highest rates of disease occur in young children < 5 years of age and adults ≥ 65 years of age. Furthermore, the incidence of invasive pneumococcal disease (IPD) in Aboriginal and Torres Straits Islanders (ATSI) adults is approximately 3 times higher than non-ATSI adults. Among children, the incidence of IPD and mortality associated with IPD is highest among infants < 1 year of age. Mortality rates are elevated in older adults, adults with comorbid conditions (e.g. diabetes mellitus, chronic lung disease, chronic liver disease), and especially in immunocompromised individuals (e.g. HIV infection, cancer, transplant, immunosuppressive therapies). Adults with 2 or more comorbid conditions may have a risk of pneumococcal disease that is comparable to that of immunocompromised individuals.
Clinical syndromes include both IPD (i.e. sepsis, meningitis, and bacteraemic pneumonia) and noninvasive disease (e.g. non-bacteraemic pneumonia and acute otitis media). Bacteraemic pneumococcal pneumonia represents approximately 80-90% of IPD cases in adults. Community acquired pneumonia (CAP) remains one of the most important causes of death from infection in many countries, with S. pneumoniae being one of the most commonly identified bacterial pathogens. Acute otitis media, a middle ear infection frequently caused by S. pneumoniae, is one of the most common infectious diseases of childhood and is a major cause of morbidity and antibiotic usage.

Clinical trials.

Clinical trials experience in children 6 weeks through 17 years of age. Six double-blind, clinical studies (Protocol 008, Protocol 024, Protocol 025, Protocol 026, Protocol 027 and Protocol 029) conducted across the Americas, Europe and Asia Pacific evaluated the immunogenicity of Vaxneuvance in healthy infants, children and adolescents. In each study, immunogenicity was assessed by serotype-specific immunoglobulin G (IgG) response rates (the proportion of participants meeting the serotype-specific IgG threshold value of ≥ 0.35 microgram/mL) and IgG geometric mean concentrations (GMCs) at 30 days following the primary series and/or following the toddler dose. In a subset of participants, opsonophagocytic activity (OPA) geometric mean titers (GMTs) were also measured at 30 days following the primary series and/or following the toddler dose.
Infants and toddlers receiving a routine vaccination schedule.

3-Dose regimen.

In a pivotal, double-blind, active comparator-controlled study (Protocol 025), 1,184 participants were randomised to receive Vaxneuvance or Prevenar 13 as a 3-dose regimen. The primary series was administered to infants at 2 and 4 months of age and the toddler dose was administered at 11 through 15 months of age. Participants also received other paediatric vaccines concomitantly, including Rotarix [rotavirus vaccine, live] with the infant primary series and Infanrix Hexa [diphtheria, tetanus, pertussis (acellular), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)] with all 3 doses in the complete regimen [see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions].
Vaxneuvance elicits immune responses, as assessed by IgG response rates, IgG GMCs and OPA GMTs, for all 15 serotypes contained in the vaccine. At 30 days following the primary series, serotype-specific IgG response rates and IgG GMCs were generally comparable for the 13 shared serotypes and higher for the 2 unique serotypes (22F and 33F) in Vaxneuvance recipients, compared to Prevenar 13 recipients. At 30 days following the toddler dose, Vaxneuvance is non-inferior to Prevenar 13 for the 13 shared serotypes and superior for the 2 unique serotypes, as assessed by the proportion of participants meeting the serotype-specific IgG threshold value of ≥ 0.35 microgram/mL (response rate) (Table 8). Serotype-specific IgG GMCs are non-inferior to Prevenar 13 for the 13 shared serotypes and superior to Prevenar 13 for the 2 unique serotypes at 30 days following the toddler dose (Table 9).

Additionally, Vaxneuvance elicits functional antibodies, as assessed by serotype-specific OPA GMTs at 30 days following the toddler dose, that are generally comparable to Prevenar 13 for the 13 shared serotypes. OPA GMTs for both 22F and 33F were higher in Vaxneuvance recipients compared to Prevenar 13 recipients.
In another double blind, active comparator controlled study (Protocol 026), 1,191 participants were randomised to receive Vaxneuvance or Prevenar 13 as a 3-dose regimen. The primary series was administered to infants at 3 and 5 months of age followed by the toddler dose at 12 months of age. Participants also received other paediatric vaccines concomitantly, including Vaxelis (Diphtheria, tetanus, pertussis [acellular, component], hepatitis B, poliovirus [inactivated], and Haemophilus type b conjugate vaccine) with all 3 doses, and MMR II (Measles, Mumps, and Rubella Virus Vaccine Live) and Varivax (Varicella Virus Vaccine Live) with the toddler dose [see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions].
Vaxneuvance elicits immune responses, as assessed by IgG response rates, IgG GMCs and OPA GMTs, for all 15 serotypes contained in the vaccine. At 30 days following the toddler dose, Vaxneuvance is non-inferior to Prevenar 13 for the 13 shared serotypes (the lower bound of the 2 sided 95% CI for the difference in the serotype-specific IgG response rates [Vaxneuvance - Prevenar 13] was greater than -10 percentage points). Vaxneuvance is superior to Prevenar 13 for the 2 unique serotypes, 22F and 33F (the lower bound of the 2-sided 95% CI for the difference in the serotype-specific IgG response rates [Vaxneuvance - Prevenar 13] was greater than 10 percentage points). Similarly, Vaxneuvance is non-inferior to Prevenar 13 for the 13 shared serotypes (the lower bound of the 2-sided 95% CI for the serotype-specific IgG GMC ratio [Vaxneuvance/ Prevenar 13] was greater than 0.5). Vaxneuvance is superior to Prevenar 13 for the 2 unique serotypes (the lower bound of the 2-sided 95% CI for the serotype-specific IgG GMC ratio [Vaxneuvance/ Prevenar 13] was greater than 2.0).
Additionally, Vaxneuvance elicits functional antibodies, as assessed by serotype-specific OPA GMTs at 30 days following the toddler dose, that are generally comparable to Prevenar 13 for the 13 shared serotypes and higher for the two unique serotypes (22F and 33F).

4-Dose regimen.

In a double-blind, active comparator-controlled study (Protocol 008), 1,051 participants were randomised in a 1:1:1 ratio to receive one of two lots of Vaxneuvance or Prevenar 13 as a 4-dose regimen. The primary series was administered to infants at 2, 4 and 6 months of age and the toddler dose was administered at 12 through 15 months of age. Vaxneuvance met non-inferiority criteria (the lower bound of the 2-sided 95% CI of the differences in the response rates [Vaxneuvance - Prevenar 13] was greater than -15 percentage points) for the 13 shared serotypes as assessed by the serotype-specific IgG response rates at 30 days after the primary series. Serotype-specific IgG GMCs at 30 days following the primary series and 30 days following the toddler dose were generally comparable across both lots of Vaxneuvance and Prevenar 13 for the 13 shared serotypes and higher in Vaxneuvance for the 2 unique serotypes (22F and 33F).
In a pivotal, double-blind, active comparator-controlled study (Protocol 029), 1,720 participants were randomised to receive Vaxneuvance or Prevenar 13 as a 4-dose regimen. The primary series was administered to infants at 2, 4, and 6 months of age and the toddler dose was administered at 12 through 15 months of age. Participants also received other paediatric vaccines concomitantly, including H-B Vax II (Hepatitis B Vaccine [Recombinant]), RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine in the infant primary series. Hiberix (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live), Varivax (Varicella Virus Vaccine Live) and Vaqta (Hepatitis A Vaccine, Inactivated) were administered concomitantly with the toddler dose [see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions].
Vaxneuvance elicits immune responses, as assessed by IgG response rates, IgG GMCs and OPA GMTs for all 15 serotypes contained in the vaccine. At 30 days following the primary series, Vaxneuvance is non-inferior to Prevenar 13 for the 13 shared serotypes, as assessed by IgG response rates. Vaxneuvance is non-inferior for the 2 unique serotypes, as assessed by the IgG response rates for serotypes 22F and 33F in recipients of Vaxneuvance compared with the response rate for serotype 23F in recipients of Prevenar 13 (the lowest response rate for any of the shared serotypes, excluding serotype 3) (Table 10).

At 30 days following the primary series, serotype-specific IgG GMCs are non-inferior to Prevenar 13 for 12 of the 13 shared serotypes. The IgG response to serotype 6A narrowly missed the prespecified non-inferiority criteria by a small margin (the lower bound of the 2-sided 95% CI for the GMC ratio [Vaxneuvance/Prevenar 13] being 0.48 versus > 0.5). Vaxneuvance is non-inferior to Prevenar 13 for the 2 unique serotypes, as assessed by serotype-specific IgG GMCs for serotypes 22F and 33F in recipients of Vaxneuvance compared with the IgG GMC for serotype 4 in recipients of Prevenar 13 (the lowest IgG GMC for any of the shared serotypes, excluding serotype 3) (Table 11).

At 30 days following the toddler dose, serotype-specific IgG GMCs for Vaxneuvance are non-inferior to Prevenar 13 for all 13 shared serotypes and for the 2 unique serotypes as assessed by the IgG GMCs for serotypes 22F and 33F in Vaxneuvance recipients compared with the IgG GMC for serotype 4 in Prevenar 13 recipients (the lowest IgG GMC for any of the shared serotypes, excluding serotype 3) (Table 12).

Additionally, IgG response rates and IgG GMCs at 30 days following the primary series and IgG GMCs at 30 days following the toddler dose were statistically significantly greater for Vaxneuvance compared to Prevenar 13 for serotype 3 and the 2 unique serotypes (22F, 33F).
Vaxneuvance elicits functional antibodies, as assessed by serotype-specific OPA GMTs at 30 days following the primary series and following the toddler dose, that are generally comparable to Prevenar 13 for the 13 shared serotypes and higher in Vaxneuvance for the 2 unique serotypes.

Infants and toddlers receiving a mixed dose regimen of different pneumococcal conjugate vaccines.

In a double-blind, active comparator-controlled, descriptive study (Protocol 027), 900 participants were randomised in a 1:1:1:1:1 ratio to one of five vaccination groups to receive a complete or mixed dosing regimen of pneumococcal conjugate vaccines. In two vaccination groups, participants received a 4-dose regimen of either Vaxneuvance or Prevenar 13. In the three other vaccination groups, the vaccination series was initiated with Prevenar 13 and changed to Vaxneuvance at Dose 2, Dose 3 or Dose 4. Participants also received other paediatric vaccines concomitantly, including Recombivax HB (Hepatitis B Vaccine [Recombinant]) and RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) [see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions]. Serotype-specific IgG GMCs at 30 days following the toddler dose were generally comparable for participants administered mixed regimens of Vaxneuvance and Prevenar 13 and for participants administered a complete dosing regimen of Prevenar 13 for the 13 shared serotypes, as assessed by IgG GMC ratios.
Infants, children and adolescents receiving a catch-up vaccination schedule. In a double-blind, active comparator-controlled, descriptive study (Protocol 024), 606 participants were randomised to receive 1 to 3 doses of Vaxneuvance or Prevenar 13, depending on age at enrollment. Children who were either pneumococcal vaccine-naïve or not fully vaccinated or completed a dosing regimen with lower-valency pneumococcal conjugate vaccines were randomised into three different age cohorts (7 through 11 months of age, 12 through 23 months of age and 2 through 17 years of age), to receive 3, 2 or 1 dose of Vaxneuvance or Prevenar 13 respectively, according to an age-appropriate schedule [see Section 4.2 Dose and Method of Administration]. Vaxneuvance elicited serotype-specific immune responses, as assessed by IgG GMCs at 30 days following the last dose of vaccine within each age cohort, for all 15 serotypes contained in the vaccine. Catch-up vaccination with Vaxneuvance elicited immune responses in children 7 months through 17 years of age that are comparable to Prevenar 13 for the shared serotypes and higher than Prevenar 13 for the unique serotypes 22F and 33F. Within each age cohort, serotype-specific IgG GMCs at 30 days following the last dose of vaccine were generally comparable between the vaccination groups for the 13 shared serotypes and higher in Vaxneuvance for the 2 unique serotypes.
Clinical trials experience in adults 18 years of age and older. Six double-blind, clinical studies (Protocol 007, Protocol 016, Protocol 017, Protocol 019, Protocol 020 and Protocol 021) conducted across the Americas, Europe and Asia Pacific evaluated the immunogenicity of Vaxneuvance in healthy and immunocompetent adults across different age groups including individuals with or without previous pneumococcal vaccination. The clinical studies included adults with stable underlying medical conditions (e.g. diabetes mellitus, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma) and/or behavioral risk factors (e.g. smoking, increased alcohol use) that are known to increase the risk of pneumococcal disease.
In each study, immunogenicity was assessed by serotype specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) responses at 30 days postvaccination. Study endpoints included OPA geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs). The pivotal study (Protocol 19) was designed to show noninferiority of the OPA GMTs compared to Prevenar 13 for the 13 shared serotypes (in common between Vaxneuvance and Prevenar 13) and superiority for the 2 serotypes unique to Vaxneuvance (22F and 33F) and for shared serotype 3. Superiority assessment was based on the between-group comparisons of OPA GMTs and proportions of participants with a ≥ 4-fold rise in serotype specific OPA titers from prevaccination to 30 days postvaccination.

Clinical trials conducted in pneumococcal vaccine naïve adults.

In the pivotal, double-blind, active comparator-controlled study (Protocol 019), 1,205 pneumococcal vaccine naïve adults aged 50 years or older were randomised to receive either Vaxneuvance or Prevenar 13. The study demonstrated that Vaxneuvance is noninferior to Prevenar 13 for the 13 shared serotypes and superior for the 2 unique serotypes and for shared serotype 3. Table 13 summarises the OPA GMTs at 30 days postvaccination. Serotype specific IgG GMCs were generally consistent with the results observed for the OPA GMTs.

In a double-blind, lot consistency study (Protocol 020), 2,340 pneumococcal vaccine-naïve adults 50 years of age and older were randomised in a 3:3:3:1 ratio to receive 1 of 3 lots of Vaxneuvance or Prevenar 13. The study demonstrated that all 3 lots are equivalent as the lower and upper limits of the 95% CI of the serotype specific OPA GMT ratios between any 2 lots were within the equivalence margin (0.5 to 2.0) for all 15 serotypes. Immune responses following vaccination with Vaxneuvance were comparable to Prevenar 13 for the shared serotypes.
In a double-blind, descriptive study (Protocol 017), 1,515 immunocompetent adults 18 to 49 years of age with or without risk factors for pneumococcal disease were randomised 3:1 to receive either Vaxneuvance or Prevenar 13, followed by Pneumovax 23 six months later. Vaxneuvance elicited immune responses to all 15 serotypes as assessed by OPA GMTs (Table 14) and IgG GMCs. OPA GMTs and IgG GMCs were generally comparable between the two vaccination groups for the 13 shared serotypes and higher in Vaxneuvance for the 2 unique serotypes. Following vaccination with Pneumovax 23, OPA GMTs and IgG GMCs were generally comparable between the two vaccination groups for all 15 serotypes in Vaxneuvance.
Immune responses in adults with no risk factors (n = 285; 25.2%) who received Vaxneuvance were generally consistent with those observed in the overall study population.

Sequential administration of pneumococcal vaccines in adults.

In a double-blind, active, comparator-controlled study (Protocol 016), 652 pneumococcal vaccine-naïve adults 50 years of age and older were randomized to receive either Vaxneuvance or Prevenar 13, followed by Pneumovax 23 one year later. Following vaccination with Pneumovax 23, OPA GMTs and IgG GMCs were comparable between the two vaccination groups for all 15 serotypes in Vaxneuvance.
Immune responses elicited by Vaxneuvance persisted up to 12 months postvaccination as assessed by OPA GMTs and IgG GMCs. Immune responses at 30 days and 12 months postvaccination were comparable between the two vaccination groups for the 13 shared serotypes and higher in Vaxneuvance for the 2 unique serotypes.
The sequential administration of Vaxneuvance followed by Pneumovax 23 was evaluated with an interval of 2 months in immunocompromised individuals (Protocol 018) and an interval of 6 months in immunocompetent individuals with or without risk factors for pneumococcal disease (Protocol 017) [see Clinical immunogenicity in special populations].

Clinical trials conducted in adults with prior pneumococcal vaccination.

In a double-blind, descriptive study (Protocol 007), 253 adults 65 years of age and older who were previously vaccinated with Pneumovax 23 at least 1 year prior to study entry were randomised to receive either Vaxneuvance or Prevenar 13. IgG GMCs and OPA GMTs were generally comparable between the vaccination groups for the 13 shared serotypes and higher in Vaxneuvance for the 2 unique serotypes.
Clinical immunogenicity in special populations.

Populations at increased risk for pneumococcal disease.

Infants born prematurely.

The immunogenicity of Vaxneuvance was evaluated in preterm infants (27 to < 37 weeks gestation at birth) enrolled within 4 double-blind, active comparator controlled studies (Protocol 025, Protocol 027 [groups receiving a complete 4 dose regimen of either Vaxneuvance or Prevenar 13, Protocol 029 and Protocol 031). In these studies, 354 participants were randomised to receive Vaxneuvance or Prevenar 13 as a 4 dose regimen with the first dose administered at 2 months of age, followed by 2 additional doses at least 4 weeks apart and a fourth dose at 11 through 15 months of age. Serotype-specific IgG and OPA responses at 30 days following the primary series, prior to the toddler dose and at 30 days following the toddler dose were generally comparable between vaccination groups for the 13 shared serotypes and higher in Vaxneuvance for the two unique serotypes (22F and 33F). The immune responses in preterm infants receiving 4 doses of Vaxneuvance were generally consistent with those observed in the overall healthy infant population in these studies (including preterm and term infants). The effectiveness of Vaxneuvance in infants born prematurely has not been established.

Children with sickle cell disease.

In a double blind, descriptive study (Protocol 023), 104 children 5 to 17 years of age with sickle cell disease were randomised 2:1 to receive a single dose of either Vaxneuvance or Prevenar 13. Vaxneuvance was immunogenic as assessed by serotype specific IgG GMCs and OPA GMTs at 30 days postvaccination for all 15 serotypes contained in Vaxneuvance. Serotype-specific IgG GMCs and OPA GMTs were generally comparable between the two vaccination groups for the 13 shared serotypes and higher in Vaxneuvance for the two unique serotypes (22F and 33F). The effectiveness of Vaxneuvance in children with sickle cell disease has not been established.

Individuals living with HIV.

Children living with HIV.

In a double blind, descriptive study (Protocol 030), 407 children 6 to 17 years of age living with HIV, with CD4+ T cell count ≥ 200 cells per microliter and plasma HIV RNA value < 50,000 copies/mL were randomised to receive a single dose of either Vaxneuvance or Prevenar 13, followed by Pneumovax 23 two months later. Vaxneuvance was immunogenic as assessed by serotype specific IgG GMCs and OPA GMTs at 30 days postvaccination for all 15 serotypes contained in Vaxneuvance. Serotype specific IgG GMCs and OPA GMTs were generally comparable for the 13 shared serotypes and higher for the 2 unique serotypes (22F and 33F). After sequential administration with Pneumovax 23, IgG GMCs and OPA GMTs were generally comparable at 30 days postvaccination between the two vaccination groups for all 15 serotypes contained in Vaxneuvance. The effectiveness of Vaxneuvance in children living with HIV has not been established.

Adults living with HIV.

In a double-blind, descriptive study (Protocol 018), 302 pneumococcal vaccine-naïve adults ≥ 18 years of age living with HIV with CD4+ T-cell count ≥ 50 cells per microliter and plasma HIV ribonucleic acid (RNA) < 50,000 copies/mL were randomised to receive either Vaxneuvance or Prevenar 13, followed by Pneumovax 23 two months later. Vaxneuvance elicited immune responses to all 15 serotypes contained in the vaccine as assessed by OPA GMTs and IgG GMCs at 30 days postvaccination. After sequential administration with Pneumovax 23, OPA GMTs and IgG GMCs were generally comparable between the two vaccination groups for all 15 serotypes.

Individuals with hematopoietic stem cell transplant.

In a double blind, descriptive study (Protocol 022), the immunogenicity of Vaxneuvance was evaluated in children (≥ 3 years of age) and adults who received an allo-HSCT 3 to 6 months prior to enrollment. All participants had a history of stable engraftment and none had uncontrolled graft-versus-host disease. In this study, 277 participants were randomised to receive 3 doses of Vaxneuvance or Prevenar 13, administered one month apart. Twelve months after allo-HSCT, participants without chronic graft-versus-host disease (cGVHD) received a single dose of Pneumovax 23 and those with cGVHD received a fourth dose of either Vaxneuvance or Prevenar 13. Vaxneuvance was immunogenic in recipients of allo-HSCT, as assessed by IgG GMCs and OPA GMTs at 30 days following the third dose of Vaxneuvance for all 15 serotypes contained in the vaccine. Serotype-specific IgG GMCs and OPA GMTs were generally comparable between the two vaccination groups for the 13 shared serotypes and higher in Vaxneuvance for the two unique serotypes (22F and 33F). Similarly, in participants who received either Vaxneuvance or Prevenar 13 twelve months after allo-HSCT, IgG GMCs and OPA GMTs at 30 days following vaccination were generally comparable between the two vaccination groups for the 13 shared serotypes and higher in Vaxneuvance for the two unique serotypes (22F and 33F). In participants who received Pnuemovax 23 twelve months after allo-HSCT, IgG GMCs and OPA GMTs at 30 days following vaccination were generally comparable between the two vaccination groups for all 15 serotypes contained in Vaxneuvance. The effectiveness of Vaxneuvance in recipients of allo-HSCT has not been established.

Adults with chronic conditions and other risk factors.

In the double-blind, descriptive study (Protocol 017), the immunogenicity of Vaxneuvance was evaluated in a subset of immunocompetent adults 18 to 49 years of age with one or more of the following risk factors for pneumococcal disease: diabetes mellitus, chronic heart disease including heart failure, chronic liver disease with compensated cirrhosis, chronic lung disease including persistent asthma and chronic obstructive pulmonary disease (COPD), current tobacco use and increased alcohol consumption. Of those who received Vaxneuvance, 54.7% (n = 620) had 1 risk factor and 20.1% (n = 228) had 2 or more risk factors. In both of these risk factor subgroups, Vaxneuvance elicited immune responses to all 15 serotypes contained in the vaccine as assessed by OPA GMTs and IgG GMCs at 30 days postvaccination, which were generally consistent with those observed in the overall study population. Sequential administration of Vaxneuvance followed by 6 months later by Pneumovax 23 was also immunogenic for all 15 serotypes contained in the vaccine.
Concomitant vaccination.

Infants and toddlers.

The immunogenicity of routine infant vaccines administered concomitantly with Vaxneuvance was evaluated within 4 double-blind, active comparator-controlled studies (Protocol 025, Protocol 026, Protocol 029 and Protocol 027). In Protocol 025, approximately 1,200 participants received Rotarix concomitantly with the infant primary series and Infanrix Hexa concomitantly with the infant primary series and toddler dose of Vaxneuvance or Prevenar 13. Immune responses to Rotarix administered concomitantly with Vaxneuvance met non-inferiority criteria, as assessed by anti-rotavirus immunoglobulin A GMTs at 30 days following completion of the primary series. Similarly, immune responses to Infanrix Hexa administered concomitantly with Vaxneuvance met non-inferiority criteria, as assessed by the antigen specific response rate to each antigen in Infanrix Hexa at 30 days following the toddler dose.
In Protocol 026, approximately 1,100 participants received Vaxelis administered concomitantly with all 3 doses of Vaxneuvance or Prevenar 13. At 30 days following the toddler dose, immune responses to the vaccine specific antigens for Vaxelis met non inferiority criteria when administered concomitantly with Vaxneuvance.
In Protocol 029, approximately 1,700 participants received Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine administered concomitantly with the infant primary series of Vaxneuvance or Prevenar 13. Approximately 1,500 participants received Vaqta, Hiberix, M-M-R II and Varivax, administered concomitantly with the toddler dose of Vaxneuvance or Prevenar 13. At 30 days following completion of the primary series, immune responses to the antigens contained in Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine met non-inferiority criteria when administered concomitantly with Vaxneuvance. At 30 days following the toddler dose, immune responses to vaccine-specific antigens for Vaqta, Hiberix, M-M-R II and Varivax met non-inferiority criteria when administered concomitantly with Vaxneuvance.
In Protocol 027, approximately 900 participants received H-B Vax II and RotaTeq concomitantly with Vaxneuvance or Prevenar 13 in the infant primary series. At 30 days following the primary series, immune responses to vaccine-specific antigens for H-B Vax II and RotaTeq met non-inferiority criteria when administered concomitantly with Vaxneuvance.
These studies support the concomitant administration of Vaxneuvance with any of the following vaccine antigens: diphtheria, tetanus, pertussis, poliomyelitis (serotypes 1, 2 and 3), hepatitis A, hepatitis B, Haemophilus influenzae type b, measles, mumps, rubella, varicella and rotavirus vaccine, either as monovalent or combination vaccines.
Concomitant administration of Vaxneuvance with meningococcal ACWY and meningococcal B vaccines has not been studied.

Adults.

In a double-blind, randomised study (Protocol 021), 1,200 adults 50 years of age and older, with or without a history of prior Pneumovax 23 vaccination, were randomised to receive Vaxneuvance concomitantly or nonconcomitantly with seasonal inactivated quadrivalent influenza vaccine (QIV). One vaccination group received Vaxneuvance and QIV concomitantly, followed by placebo 30 days later. A second vaccination group received QIV and placebo concomitantly, followed by Vaxneuvance 30 days later.
Vaxneuvance administered concomitantly with QIV is noninferior to Vaxneuvance administered nonconcomitantly with QIV (based on a 2-fold noninferiority margin), as assessed by pneumococcal OPA GMTs at 30 days postvaccination with Vaxneuvance for all 15 serotypes contained in the vaccine. OPA GMTs were slightly lower for some serotypes when Vaxneuvance was administered concomitantly with QIV compared to Vaxneuvance administered alone. QIV administered concomitantly with Vaxneuvance is noninferior to QIV administered nonconcomitantly (based on a 2-fold noninferiority margin) as assessed by influenza strain-specific hemagglutination inhibition (HAI) GMTs at 30 days postvaccination with QIV for all 4 influenza strains.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

Vaxneuvance has not been evaluated for the potential to cause genotoxicity.

Carcinogenicity.

Vaxneuvance has not been evaluated for the potential to cause carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Histidine, polysorbate 20, sodium chloride, water for injections.
For adjuvant, see Section 2 Qualitative and Quantitative Composition.
The product does not contain antimicrobial preservative.

6.2 Incompatibilities

In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light.
Vaxneuvance should be administered as soon as possible after being removed from the refrigerator.
In the event of temporary temperature excursions, stability data indicate that Vaxneuvance is stable at temperatures up to 25°C for 48 hours.

6.5 Nature and Contents of Container

Vaxneuvance is presented as a suspension in 0.5 mL single-dose pre-filled syringes (Type I glass) in packs of 1 and 10.
The tip cap and plunger stopper of the pre-filled syringe are not made with natural rubber latex.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

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