Consumer medicine information

Quadracel

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine; Poliomyelitis vaccine (inactivated)

BRAND INFORMATION

Brand name

Quadracel

Active ingredient

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine; Poliomyelitis vaccine (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Quadracel.

SUMMARY CMI

QUADRACEL®

Consumer Medicine Information (CMI) summary

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

1. Why does my child need Quadracel?

Quadracel is a vaccine. It is used to help prevent whooping cough (pertussis), tetanus, diphtheria and polio, in infants and children.

For more information, see Section 1. Why does my child need Quadracel? in the full CMI.

2. What should I know before my child is given Quadracel?

Do not use if your child ever had an allergic reaction to Quadracel or any of the ingredients listed at the end of the CMI.

Talk to your doctor if your child has or had any other medical conditions or is taking other medicines.

For more information, see Section 2. What should I know before my child is given Quadracel? in the full CMI.

3. What if my child is taking other medicines?

Some medicines may interfere with Quadracel and affect how it works.

A list of these medicines is in Section 3. What if my child is taking other medicines? in the full CMI.

4. How Quadracel is given?

Quadracel is given by a doctor or nurse as an injection into muscle.

More instructions can be found in Section 4. How is Quadracel given? in the full CMI.

5. What should I know after my child is given Quadracel?

Things you should do
  • Keep an updated record of vaccinations.
  • Keep follow-up appointments with your doctor or clinic.
Looking after your medicineQuadracel is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Quadracel:
  • keep in the fridge between 2-8°C. Do not freeze.

For more information, see Section 5. What should I know after my child is given Quadracel? in the full CMI.

6. Are there any side effects?

Common side effects include local reaction around the injection site (redness, swelling, and tenderness), vomiting, fever, crying, decreased eating, diarrhoea, fussiness, decreased activity, sleepiness, listlessness. Serious side effects include abscess at the injection site, sudden signs of allergic reactions such as rash, itching or hives on the skin and shortness of breath, convulsion with or without high temperature, unusual muscle slackness, pale skin or bluish appearance to finger nails or lips, large injection site reactions including limb swelling.

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



FULL CMI

QUADRACEL®

Active ingredient(s): Diphtheria toxoid, Tetanus toxoid, Pertactin, Pertussis filamentous haemagglutinin, Pertussis fimbriae 2 + 3, Pertussis toxoid, and Poliovirus.

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why does my child need Quadracel?
2. What should I know before my child is given Quadracel?
3. What if my child is taking other medicines?
4. How Quadracel is given?
5. What should I know after my child is given Quadracel?
6. Are there any side effects?
7. Product details

1. Why does my child need Quadracel?

Quadracel contains the active ingredients Diphtheria toxoid, Tetanus toxoid, Pertactin, Pertussis filamentous haemagglutinin, Pertussis fimbriae 2 + 3, Pertussis toxoid, and Poliovirus. Quadracel is a combination vaccine used to help prevent four diseases, whooping cough (pertussis), tetanus, diphtheria and polio, in infants and children. Polio, whooping cough, tetanus and diphtheria cause significant sickness and sometimes death in unvaccinated infants, children, and adults.

This vaccine is for use in children up to 6 years of age, and is used in infants from the age of 2 months who are at the greatest risk from these diseases.

How Quadracel works

Quadracel works by causing the body to produce its own protection against whooping cough, tetanus, diphtheria, and polio. It does this by making substances called antibodies in the blood, which fight the bacteria and toxins that cause these diseases. If a vaccinated person comes into contact with these bacteria and toxins, the body is usually ready to destroy them.

Most children will produce enough antibodies against these diseases. However, as with all vaccines, 100% protection cannot be guaranteed.

The vaccine will not give your child any of these diseases.

The chance of a severe reaction from Quadracel is very small, but the risks from not being vaccinated against these diseases may be very serious.

2. What should I know before my child is given Quadracel?

Warnings

Do not use Quadracel if your child:

  • is allergic to Diphtheria toxoid, Tetanus toxoid Pertactin, Pertussis filamentous haemagglutinin, Pertussis fimbriae 2 + 3, Pertussis toxoid, and Poliovirus, or any of the ingredients listed at the end of this leaflet.
  • had an anaphylactic or other allergic reaction to a previous dose of this vaccine or another vaccine designed to protect against whooping cough, tetanus, diphtheria and polio.
  • had a serious nervous system disorder within 7 days after a previous whooping cough vaccine.
  • has progressive nervous system disorder such as infant spasm, uncontrolled epilepsy. The vaccination may be considered only after a treatment has been established and the condition is stabilised.
  • an illness with febrile or acute infection. The vaccination shall be postponed until after the child has recovered.

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if your child:

  • has reacted to Quadracel or any other vaccine with any of the following:
    - life-threatening allergic reaction.
    - shock-like state or being unresponsive for a long period of time. Symptoms include shallow breathing, breathing which stops temporarily, skin pale when compared to normal healthy skin colour.
    - convulsions with or without high temperature within 3 days.
    - high temperature (greater than 40.5°C).
    - persistent crying lasting for more than 3 hours within 48 hours.
  • has or had any medical conditions, especially the following:
    - lowered immunity due to diseases (such as HIV/AIDS or cancer) or medicines used to treat cancer including radiation therapy.
    - a higher risk of convulsion than the general population.
    - a bleeding disorder.
  • has fainted with previous injections. Fainting can occur following, or even before, any needle injections

After vaccination, 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?

3. What if my child is taking other medicines?

Tell your doctor or pharmacist if your child is taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor if your child has been treated with medicines that may affect the body's natural defenses (immune system) such as chemotherapy. Response to vaccines may not be optimal.

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

4. How Quadracel is given?

How much to use

  • Quadracel is given by a doctor or nurse as an injection into muscle.
  • For infants under the age of 12 months, Quadracel is given as an injection into the upper thigh muscle. In older children who have started walking, the vaccine is usually injected into the upper arm muscle.

When to use Quadracel

  • The primary immunisation schedule is one 0.5 mL dose given at 2, 4 and 6 months of age. A booster dose may be given at 15 months to 6 years of age.

If your child misses a dose of Quadracel

If your child misses a dose, talk to your doctor and arrange another visit as soon as possible.

If your child received too much Quadracel

Overdose is most unlikely because your doctor or nurse gives the injections. If you have any concerns, ask your doctor.

5. What should I know after my child is given Quadracel?

Things you should do

  • Keep an updated record of your child's vaccinations.
  • Keep follow-up appointments with your doctor or clinic.
It is important your child has follow-up doses of Quadracel at the appropriate times to make sure the vaccine has the best chance of providing protection against whooping cough, tetanus, diphtheria, and polio.

Call your doctor straight away if your child:

  • does not feel well after having Quadracel

Remind any doctor, dentist or pharmacist you visit your child had Quadracel.

Looking after your child's medicine

Quadracel is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Quadracel:

  • Keep Quadracel where children cannot reach it.
  • Keep Quadracel in the original pack until it is time for it to be given.
  • Keep Quadracel in the refrigerator, between 2°C and 8°C. Do not freeze Quadracel. Freezing destroys the vaccine.

Getting rid of any unwanted medicine

If your child no longer needs to use this vaccine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this vaccine after the expiry date.

6. Are there any side effects?

All medicines including vaccines can have side effects. If your child experiences 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 or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • local reaction around the injection site such as redness, swelling, and tenderness
  • fussiness
  • decreased activity
  • decreased eating
  • crying or screaming
  • fever
  • vomiting
  • diarrhoea
  • sleepiness
  • listlessness
Speak to your doctor if your child has any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • abscess at the injection site
  • sudden signs of allergic reactions such as rash, itching or hives on the skin and shortness of breath
  • convulsions with or without high temperature
  • pale skin or bluish appearance to finger nails or lips
  • unusual muscle slackness
  • large injection site reactions including limb swelling
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

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

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

Reporting side effects

After you have received medical advice for any side effects your child experienced, 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.

Always make sure you speak to your doctor or pharmacist before you decide to stop giving any medicines to your child.

7. Product details

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

What Quadracel contains

Active ingredient
(main ingredient)
  • 20 microgram pertussis toxoid
  • 20 microgram pertussis filamentous haemagglutinin
  • 5 microgram pertussis fimbriae Types 2+3
  • 3 microgram pertussis pertactin
  • at least 30 IU (15 LF) diphtheria toxoid
  • at least 40 IU (5 LF) tetanus toxoid
  • 40 D-antigen Units Poliovirus inactivated type 1, Vero (Mahoney)
  • 8 D-antigen Units Poliovirus inactivated type 2, Vero (MEF-1)
  • 32 D-antigen Units Poliovirus inactivated type 3, Vero (Saukett)
Other ingredients
(inactive ingredients)
  • aluminium phosphate
  • phenoxyethanol
  • polysorbate 80

Quadracel may also contain traces of the following:

  • bovine serum albumin
  • formaldehyde
  • glutaral
  • neomycin
  • streptomycin sulfate
  • polymyxin B sulfate
Potential allergensNo

The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

Your child should not receive this vaccine if they are allergic to any of these ingredients.

What Quadracel looks like

Quadracel is a sterile, uniform, white to off-white suspension for injection.

AUST R 91355 (vial), AUST R 385069 (pre-filled syringe)

Who distributes Quadracel

Australia:

sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia

Tel: 1800 818 806

New Zealand:

sanofi-aventis new zealand limited
56 Cawley St
Ellerslie
Auckland
New Zealand

Tel: 0800 283 684

This leaflet was prepared in May 2022.

quad-ccdsv8-cmiv5-24may22

Published by MIMS July 2022

BRAND INFORMATION

Brand name

Quadracel

Active ingredient

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine; Poliomyelitis vaccine (inactivated)

Schedule

S4

 

1 Name of Medicine

Pertussis vaccine acellular and diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus types 1, 2 and 3 (Vero cell).

2 Qualitative and Quantitative Composition

Each 0.5 mL dose of Quadracel contains:
Diphtheria toxoid ≥ 30 IU (15 Lf);
Tetanus toxoid ≥ 40 IU (5 Lf);
Pertussis toxoid (PT) 20 microgram;
Pertussis filamentous haemagglutinin (FHA) 20 microgram;
Pertactin (PRN) 3 microgram;
Pertussis fimbriae 2 + 3 (FIM) 5 microgram;
Poliovirus inactivated type 1, Vero (Mahoney) 40 D-antigen units;
Poliovirus inactivated type 2, Vero (MEF-1) 8 D-antigen units;
Poliovirus inactivated type 3, Vero (Saukett) 32 D-antigen units;
Absorbed on 1.5 mg aluminium phosphate (0.33 mg aluminium).
This product does not contain thiomersal.
The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of variant Creutzfeldt-Jakob disease (vCJD) (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
Diphtheria toxoid is a cell free preparation of diphtheria toxin detoxified with formaldehyde.
Tetanus toxoid is prepared by detoxification of tetanus toxin with formaldehyde.
Each of the three strains of poliovirus is individually grown in Vero cells cultivated on microcarriers. The single virus harvest is concentrated and purified, then inactivated with formaldehyde to produce the type 1, 2 or 3 monovalent. Monovalents of each type are then combined in appropriate quantities to produce a trivalent concentrate.
The 5 component pertussis antigens, pertussis toxoid (PT), pertussis filamentous haemagglutinin (FHA), pertactin (PRN) and pertussis fimbriae types 2 + 3 (FIM), contained in Quadracel are the same as those in Tripacel or Pediacel. Tripacel consists of an acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTPa), and has lesser amounts of PT and FHA, while Quadracel has pertussis formulations that are similar to Pediacel. Quadracel contains DTPa combined with inactivated poliovirus vaccine (IPV).
This product contains residual streptomycin sulfate, neomycin and polymyxin B sulfate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Quadracel is a sterile, uniform, cloudy white to off-white suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis, and poliomyelitis.
Quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

4.2 Dose and Method of Administration

Dose.

For primary immunisation of infants, the following routine Quadracel immunisation schedule is recommended: one 0.5 mL dose administered intramuscularly at 2, 4 and 6 months of age.
A fourth dose of Quadracel may be administered as a booster dose for children from 15 months to 6 years of age who have been immunised previously with up to three doses of diphtheria, tetanus, pertussis and polio vaccines.
The vaccine should not be administered to individuals after their seventh birthday (see Section 4.4 Special Warnings and Precautions for Use).
Infants born prematurely whose clinical condition is satisfactory should be vaccinated according to their chronological age from birth.

Administration.

Inspect for extraneous particulate matter and/or discolouration before use. If these conditions exist, the product should not be administered.
Shake the vial or syringe well to distribute uniformly the suspension before withdrawing each dose. When administering a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place. Once the vial has been opened, any of its contents not used immediately should be discarded. Aseptic technique must be used for withdrawal of the dose.
Administer the vaccine intramuscularly. The anterolateral thigh is the preferred site for vaccination in infants and children under 12 months of age. In older children, the deltoid muscle is usually large enough for injection. Separate syringes, separate injection sites and preferably separate limbs must be used in case of concomitant administration.
Do not administer the product intravascularly or subcutaneously.
Needles should not be recapped and should be disposed of properly.
Product is for single use in one patient only. Discard any residue.

4.3 Contraindications

Hypersensitivity.

Quadracel should not be administered to anyone with a history of severe allergic reaction to any component of the vaccine (components listed, see Section 2 Qualitative and Quantitative Composition; Section 6.1 List of Excipients) or after previous administration of the vaccine or a vaccine containing the same components or constituents.

Febrile or acute disease.

Vaccination should be postponed in cases of moderate or severe febrile and/or acute disease. Low-grade fever does not constitute a contraindication.

Neurological disorders.

The following events are contraindications to administration of any pertussis-containing vaccine, including Quadracel:
Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause.
Progressive neurological disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilised.

4.4 Special Warnings and Precautions for Use

Prior history of severe adverse events following pertussis vaccination.

If any of the following events occur within the specified period after administration of a whole cell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision to administer Quadracel should be based on careful consideration of potential benefits and possible risks. The following events require consideration of whether further doses of Quadracel should be given:
temperature of ≥ 40.5°C within 48 hours, not attributable to another identifiable cause;
collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
persistent crying lasting ≥ 3 hours within 48 hours;
convulsions with or without fever within 3 days.

Hypersensitivity.

Bovine serum albumin, formaldehyde and glutaral have been used in the manufacturing process of this product and residual trace amounts may be present in the final product. Therefore, a hypersensitivity reaction may occur.
Neomycin, polymyxin B sulfate and streptomycin sulfate have been used in the manufacturing process of this product. As each dose may contain residual trace amounts of neomycin, polymyxin B sulfate and streptomycin sulfate, caution must be exercised when the vaccine is administered to individuals with hypersensitivity to these antibiotics (and other antibiotics of the same class).
The rates and severity of adverse events in recipients of tetanus toxoid are influenced by the number of prior doses and level of pre-existing antitoxins.
As with other injectable vaccines, appropriate medical treatment and supervision should always be available in case of anaphylactic reactions. Adrenaline (epinephrine) should always be readily available whenever the injection is given.

Protection.

As with any vaccine, immunisation with Quadracel may not protect 100% of susceptible individuals.

Neurological adverse events.

A review by the US Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome (GBS). If GBS occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give Quadracel or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
For infants or children at higher risk for seizures than the general population, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular pertussis component (including Quadracel) and for the following 24 hours, to reduce the possibility of post-vaccination fever.
Hypotonic-hyporesponsive episodes (HHEs) rarely follow vaccination with whole-cell pertussis containing DTP vaccines and occur even less commonly after acellular pertussis-containing DTP vaccines and DT vaccines. A history of HHEs is not a contraindication to the use of acellular pertussis vaccines, but caution should be exercised in these cases.

Administration route-related precautions.

Do not administer by intravascular route.
As with all parenterals, this vaccine must be administered with caution to individuals with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular injection.

Serious and severe adverse events-related precautions.

In persons who have a history of serious or severe reactions following a previous injection with the same vaccine or a vaccine containing similar components, the risks and benefits of vaccination must be carefully considered.
Before injection of any biological, the person responsible for administration must take all known precautions for the prevention of allergic or any other reaction. As with all parenteral vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine.

Altered immune status.

The immunogenicity of Quadracel could be reduced by immunosuppressive treatment. In such cases, it is recommended to postpone the vaccination until the end of the immunosuppression. Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.

Syncope related precautions.

Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury and to manage syncope.

Use in the elderly.

Quadracel should not be used in adults.

Paediatric use.

The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Effects on laboratory tests.

Interference of Quadracel with laboratory tests has not been studied.

4.5 Interactions with Other Medicines and Other Forms of Interactions

When both vaccines are indicated, Quadracel may be used to reconstitute Act-HIB (Haemophilus influenzae type b polysaccharide conjugated to tetanus protein) for simultaneous administration of all 5 antigens in a single injection. Quadracel must not be mixed in the same syringe with any other vaccines.
There are currently no data regarding the concomitant administration of Quadracel with MMR or hepatitis B vaccine. The Australian Immunisation Handbook accepts that inactivated vaccines can be given during the same visit at separate sites with separate syringes.
Immunosuppressive treatments may interfere with the development of the expected immune response.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Quadracel has not been evaluated for the effects on fertility.
Not applicable. This vaccine is not intended for administration to women of child-bearing age.
 Not applicable. This vaccine is not intended for administration to women of child-bearing age.

4.7 Effects on Ability to Drive and Use Machines

Not applicable - for paediatric use only.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials experience.

Safety information described below are based upon studies with Quadracel formulated with MRC-5 cell-derived IPV.
The most frequent reactions observed with Quadracel include redness and tenderness at the injection site, irritability and slight fever. These symptoms usually occur within the first 24 hours after vaccination and may continue for 24-48 hours. The rates of adverse events observed in children who received Quadracel at 2, 4, 6 and 18 months of age during a clinical trial with the vaccine in Canada are shown in Table 1.
In a clinical trial conducted in Sweden comparing three acellular pertussis vaccines and one whole cell DTP vaccine, 20,745 infants received a "hybrid" formulation of Tripacel which contained the same amounts of pertussis antigens as in Quadracel at 2, 4 and 6 or 3, 5 and 12 months of age. Rates of adverse events were less than or comparable to the rates in the other acellular pertussis vaccine and whole cell DTP groups in this study. The rates of reports of fever > 40.5°C and seizures or suspected seizures were significantly higher following whole cell DTP than following acellular pertussis vaccines. Rates of hypotonic/hyporesponsive episodes were comparable, with 29 reports following administration of Tripacel. No deaths or cases of encephalitis/acute encephalopathy, invasive bacterial infection, infantile spasms or anaphylactic reactions were reported within 48 hours of vaccination.
There are currently no clinical data to support administration of a fifth dose with Quadracel. In a study conducted by the U.S. National Institutes of Health (NIH), thirteen different formulations of acellular pertussis vaccines combined with diphtheria and tetanus toxoids (DTPa), including Tripacel (containing less PT and FHA than Quadracel), were evaluated for safety and immunogenicity when administered at 2, 4, 6 and 18 months, and 4 - 6 years of age. In an analysis of fourth and fifth dose follow-up studies from this multicenter trial, entire limb swelling was reported in 20 children (2%) of 1,015 children who received four consecutive doses of the same DTPa. It was found that large injection site reactions occurred more frequently after the fifth dose of DTPa than after the previous fourth dose. No reports were received of entire limb swelling in 121 children who received a fifth dose of the same DTPa. In 146 recipients who received 5 doses with different DTPa vaccines, 4 (2.7%) children were reported to have such swelling. In all reports the swelling subsided spontaneously and completely, without sequelae.

Data from postmarketing experience.

The following additional adverse events have been spontaneously reported during the postmarketing use of Quadracel worldwide. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Immune system disorders.

Anaphylactic reaction, hypersensitivity and allergic reactions (such as rash, urticaria, dyspnoea).

Psychiatric disorders.

Screaming.

Nervous system disorders.

Somnolence, convulsion, febrile convulsion, hypotonic-hyporesponsive episode, hypotonia.

Cardiac disorders.

Cyanosis.

Vascular disorders.

Pallor.

General disorders and administration site conditions.

Injection site reactions (including inflammation, mass, abscess and sterile abscess), oedema.
Listlessness.
Large injection site reactions (> 50 mm), including limb swelling which may extend from the injection site beyond one or both joints have been reported in children following Quadracel administration. These reactions usually start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site, and resolve spontaneously within 3-5 days. The risk appears to be dependent on the number of prior doses of d/DTPa vaccine, with a greater risk following the 4th and 5th doses.

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 www.tga.gov.au/reporting-problems.

4.9 Overdose

There are no reports of overdosage.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Bacterial and Viral Vaccines, Combined, ATC code: J07CA02.

Clinical trials.

Clinical trial results described below are based upon studies with Quadracel formulated with MRC-5 cell-derived IPV.

Studies of protective efficacy of Tripacel against pertussis.

A randomised controlled double blind efficacy study was conducted in Sweden (Trial 1) where 2,551 infants received the regular formulation of Tripacel (containing lower concentrations of PT and FHA than Quadracel) and 2,539 received a control vaccine containing diphtheria and tetanus toxoids at 2, 4 and 6 months of age. Tripacel was shown to have an absolute vaccine efficacy of 85% (95% CI: 81%-89%) against pertussis disease (defined as at least 21 days of paroxysmal cough with culture, serologic or epidemiologic confirmation of infection with Bordetella pertussis). The incidence of local and systemic reactions after administration of Tripacel was comparable to the diphtheria tetanus vaccine (DT) control group.
A second randomised, double blind controlled efficacy trial (Trial 2) was carried out in Sweden with 82,892 infants comparing 3 acellular pertussis and one European whole cell DTP vaccines where 20,746 infants received a "hybrid" formulation of Tripacel (DTPa) which contained the same concentration of pertussis antigens as Quadracel, at 2, 4 and 6 (n = 2,552) or 3, 5 and 12 (n = 18,194) months of age. The "hybrid" Tripacel and the European whole cell DTP vaccine had similar and high efficacy against culture confirmed pertussis irrespective of duration. The other acellular pertussis combination vaccines were less effective. Rates of adverse events were less than or comparable to the rates observed in the other acellular pertussis and European whole cell DTP groups in this study.

Immunogenicity of Quadracel.

In a clinical trial conducted in Canada, infants received either Pediacel (n = 339), Penta [Act-HIB reconstituted with a whole cell pertussis DTP-IPV vaccine] (n = 112), Poliacel [Quadracel used to reconstitute Act-HIB] (n = 335), or Quadracel and Act-HIB, given at separate sites at the same visit (n = 113) at 2, 4 and 6 months of age. Of the 899 children enrolled, 798 received a fourth dose of the same vaccine at 18-20 months of age. Serologic responses are shown in Table 2.
The following antibody levels are considered to be protective: diphtheria, diphtheria antitoxin levels ≥ 0.01 IU/mL; tetanus, tetanus antitoxin levels ≥ 0.01 IU/mL; and poliomyelitis, neutralising poliovirus antibody titre levels ≥ 1:8.
The pertussis antibody responses observed with Quadracel were comparable to those observed following administration of the two different formulations of Tripacel (component pertussis vaccine combined with diphtheria and tetanus toxoids adsorbed), given at 2, 4 and 6 months, in the two Swedish pertussis efficacy trials (Table 3).

5.2 Pharmacokinetic Properties

No pharmacokinetic studies have been performed.

5.3 Preclinical Safety Data

Genotoxicity.

Quadracel has not been evaluated for the genotoxic potential.

Carcinogenicity.

Quadracel has not been evaluated for the carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Aluminium phosphate, phenoxyethanol, polysorbate 80.
Manufacturing process residuals include bovine serum albumin, formaldehyde, glutaral, streptomycin sulfate, neomycin and polymyxin B sulfate.

6.2 Incompatibilities

Clinical studies have demonstrated that Quadracel may be used to reconstitute freeze dried Act-HIB.
The vaccine must not be mixed with other vaccines or medicinal products (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

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 at 2° to 8°C. Refrigerate. Do not freeze. Do not use after expiry date.

6.5 Nature and Contents of Container

Single dose vial containing 0.5 mL of vaccine.

Pack of 1, 5 or 10 vials.

Single dose pre-filled syringe containing 0.5 mL of vaccine.

Pack of 10 syringes.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

After use, any remaining vaccine and container must be disposed of safely according to locally agreed procedures.

6.7 Physicochemical Properties

No data available.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes