Consumer medicine information

Boostrix

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine

BRAND INFORMATION

Brand name

Boostrix (preservative free)

Active ingredient

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Boostrix.

What is in this leaflet

This leaflet answers some of the common questions about BOOSTRIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of having BOOSTRIX against the expected benefits.

If you have any concerns about receiving BOOSTRIX talk to your doctor, nurse or pharmacist

Keep this leaflet with this vaccine. You may need to read it again.

What BOOSTRIX is used for

BOOSTRIX is a vaccine used as a booster to prevent three diseases: diphtheria, tetanus and pertussis (whooping cough) in adults and children aged 4 years and older who have been previously vaccinated against these diseases. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

Diphtheria, tetanus, and pertussis are all serious life-threatening diseases caused by bacterial infection.

Diphtheria
Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and death. The risk of serious complications and death is greater in the very young and elderly.

Tetanus (Lockjaw)
Tetanus bacteria enter the body through wounded skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and death. The spasms can be strong enough to cause bone fractures of the spine. The death rate is 10% of cases.

Pertussis (Whooping cough)
Pertussis is a highly infectious illness. The disease affects the breathing tract causing severe spells of coughing that may interfere with normal breathing. The coughing is often accompanied by a ‘whooping’ sound. The cough may last for 1-2 months or longer. Pertussis can also cause inner ear infections, long-lasting bronchitis, pneumonia, fits, brain damage and death. The risk of severe complications and death is greatest in infants under 6 months of age. The death rate is 0.5% for infants under 6 months of age.

Vaccination is the best way to protect against these diseases. BOOSTRIX vaccine cannot give your child diphtheria, tetanus or pertussis infection. The vaccine will not protect against diseases caused by other types of bacteria or organisms.

A primary course of tetanus, diphtheria and pertussis vaccine is usually given during early childhood.

Before Boostrix is given

Boostrix should not be given if:

  • you or your child has had an allergic reaction to BOOSTRIX, or any ingredient contained in this vaccine. The ingredients in BOOSTRIX are listed at the end of this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
  • you or your child had BOOSTRIX before and became unwell, tell your doctor, nurse or pharmacist before the next dose is given.
  • you or your child has had an allergic reaction to any other diphtheria, tetanus or pertussis containing vaccine (such as Infanrix, Tripacel or Triple Antigen vaccine).
  • you or your child experienced a disease of the brain within 7 days after previous vaccination with a pertussis containing vaccine.
  • you or your child had a low blood platelet count or bled or bruised more easily following earlier immunisation against diphtheria and/or tetanus even if only for a short time.
  • you or your child suffered from problems associated with your nervous system following earlier immunisation against diphtheria and/or tetanus even if only for a short time.
  • you or your child has a severe infection with a high temperature. A minor infection such as a cold should not be a problem, but talk to your doctor or nurse about this before vaccination.
  • your child under 11 years of age has not received a complete course of diphtheria or tetanus vaccine previously.
  • your child is less than 4 years of age. The vaccine is only intended for use in children 4 years and older, adolescents and adults. The vaccine may not be as effective in infants younger than 4 years of age, because it is a low strength vaccine meant for older children and adults.
  • the expiry date printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

If you are not sure whether your child should have BOOSTRIX vaccine, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for your child.

Tell your doctor if:

You or your child has any medical problems such as:

  • neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy (a disease of the brain)
  • lowered immunity due to medical treatment or a medical condition
  • a tendency to febrile convulsions (seizures/fits due to a fever or high body temperature)
  • you or your child have a bleeding problem or bruise(s) easily
  • you or your child had any problems after receiving BOOSTRIX previously
  • you or your child has not previously received the full course of diphtheria and tetanus vaccination.
  • you or your child experienced any problems after having a pertussis-containing vaccine (such as Infanrix, Tripacel or Triple Antigen), especially:
    - a high temperature (over 40.0°C) within 2 days of vaccination
    - a collapse or shock-like state within 2 days of vaccination
    - crying lasting 3 hours or more within 2 days of vaccination
    - convulsions (seizures/fits) with or without a fever within 3 days of vaccination
  • you or your child has received another vaccine recently, or is having any prescription or OTC (over-the-counter) medicines. In particular mention if your child is being given medicines which suppress the immune system, such as high-dose steroids
  • you are, or think you may be pregnant or if you intend to become pregnant. Your doctor will discuss with you the possible risks and benefits of receiving BOOSTIX during pregnancy (in particular during the 3rd trimester)
  • you are breast feeding. It is not known if BOOSTRIX passes into breast milk
  • you or your child fainted with a previous injection. Fainting can occur following, or even before, any needle injection.

Taking other medicines

Some vaccines may be affected by other vaccines or medicines. Your doctor, nurse or pharmacist will be able to tell you what to do if BOOSTRIX is to be given with another vaccine or medicine.

How BOOSTRIX is given

The doctor or nurse will give BOOSTRIX as an injection.

If you have any concerns about how this vaccine is to be given, talk to your doctor, nurse or pharmacist.

How much is given

The dose of BOOSTRIX is 0.5mL.

How it is given

BOOSTRIX will be injected into the upper arm muscle.

The vaccine should never be given intravenously (into the vein).

When it is given

BOOSTRIX is generally given whenever a booster dose of diphtheria and tetanus vaccine is required and where a booster for pertussis is desired.

BOOSTRIX may also be given in the case of a tetanus-prone injury where a booster for diphtheria and pertussis is also required, provided no previous dose of tetanus vaccine was given within five years previously.

Side effects

Tell your doctor or nurse as soon as possible if you or your child does not feel or look well during or after having had a dose of BOOSTRIX vaccine.

BOOSTRIX helps protect most people from diphtheria, tetanus and pertussis infection, but it may have unwanted side effects. All medicines and vaccines can have side effects. Sometimes they are serious, most of the time they are not. Some side effects may need medical treatment. The chance of you or your child having a serious side effect is very much less than the chance of your child having a permanent injury from the natural infections.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Most unwanted effects with BOOSTRIX are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site. Side effects are more likely to occur with booster dosing.

As with all injectable vaccines, severe allergic reactions (e.g. anaphylactic reactions) may very rarely occur (with up to 1 in 10,000 doses of the vaccine). These can be recognized by:

  • itchy rash of the hands and feet
  • swelling of the eyes and face
  • difficulty in breathing or swallowing
  • sudden drop in blood pressure and loss of consciousness.

These reactions will usually occur before leaving the doctor’s surgery. However, if you or your child gets any of these symptoms you should contact a doctor urgently.

Side effects that occurred in children from 4 to 9 years of age

Very common (these may occur with more than 1 in 10 doses of the vaccine):

  • irritability
  • sleepiness
  • swelling, pain, redness where the injection was given
  • tiredness

Common (these may occur with up to 1 in 10 doses of the vaccine):

  • loss of appetite
  • headache
  • vomiting and diarrhoea
  • fever (more than 37.5°C)

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

  • upper respiratory tract infection
  • disturbances in attention
  • discharge with itching of the eyes and crusty eyelids (conjunctivitis)
  • skin rash
  • pain
  • hard lump where the injection was given

Side effects that occurred in adults, teenagers and children from the age of 10 years onwards

Very common (these may occur with more than 1 in 10 doses of the vaccine):

  • headache
  • swelling, pain, redness where the injection was given
  • tiredness
  • generally feeling unwell

Common (these may occur with up to 1 in 10 doses of the vaccine):

  • dizziness
  • nausea
  • fever (more than 37.5°C)
  • hard lump and abscess at the injection site

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

  • upper respiratory tract infection
  • sore throat and discomfort when swallowing
  • swollen glands in the neck, armpit or groin
  • fainting
  • cough
  • diarrhoea
  • vomiting
  • excessive sweating
  • itching
  • skin rash
  • joint stiffness
  • joint pain
  • muscle ache
  • fever (more than 39°C)
  • flu-like symptoms, such as fever, sore throat, runny nose, cough and chills
  • pain

The following side effects are not specific for any age group:

Rare (these may occur with up to 1 in 1,000 doses of the vaccine):

  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • seizures (with or without fever)
  • hives
  • large swelling of the injected limb
  • unusual weakness

Other side effects not listed above, can also occur during or soon after a dose of BOOSTRIX.

Check with your doctor or nurse if you or your child has any other effects.

Do not be alarmed by this list of possible side effects. You or your child may not experience any of them.

Storage

BOOSTRIX vaccine is usually stored at the doctor’s clinic or surgery, or at the pharmacy. But if you need to store BOOSTRIX always:

  • Keep BOOSTRIX in the refrigerator, stored between +2°C and +8°C.

THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.

  • Keep the vaccine out of the reach of children.
  • Keep BOOSTRIX in the original pack until it is time for it to be given.
  • Protect from light.

Ask your pharmacist what to do with any left over BOOSTRIX vaccine that has expired or has not been used.

Product description

What it looks like

BOOSTRIX comes in glass vials and prefilled syringes. It is a white, slightly milky liquid.

Ingredients

The active ingredients of BOOSTRIX are non-infectious substances from tetanus, diphtheria bacteria and purified proteins of pertussis bacteria.

The vaccine cannot cause these diseases.

Each 0.5mL dose contains:

  • ≥ 2 IU (2.5 Lf U) of diphtheria toxoid
  • ≥ 20 IU (5 Lf U) of tetanus toxoid
  • 8 mcg of pertussis toxoid, 8 mcg of filamentous haemagglutinin and 2.5 mcg of pertactin

The inactive ingredients in the vaccine are: aluminium hydroxide hydrate, aluminium phosphate, formaldehyde, polysorbate 80, sodium chloride (salt), glycine and water.

The manufacture of this product includes exposure to bovine derived 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.

Further Information

BOOSTRIX is only available if prescribed by a doctor.

BOOSTRIX comes in a glass vial (AUST R 158362) or as a prefilled syringe (AUST R 158363).

DISTRIBUTED IN AUSTRALIA BY:

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, Victoria, 3067
Australia.

Date of Preparation:
10 March 2020

Version 7.0

Trade marks are owned by or licensed to the GSK group of companies.

© 2020 GSK group of companies or its licensor.

Published by MIMS August 2020

BRAND INFORMATION

Brand name

Boostrix (preservative free)

Active ingredient

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine

Schedule

S4

 

1 Name of Medicine

Combined diphtheria-tetanus-acellular pertussis (dTpa) vaccine.

2 Qualitative and Quantitative Composition

Boostrix dTpa vaccine is a sterile suspension which contains diphtheria toxoid, tetanus toxoid and three purified antigens of Bordetella pertussis [pertussis toxoid (PT), pertussis filamentous haemagglutinin (FHA) and pertactin (PRN)] adsorbed onto aluminium salts.
1 dose (0.5 mL) contains: diphtheria toxoid1 not less than 2 International Units (IU) (2.5 Lf);
tetanus toxoid1 not less than 20 International Units (IU) (5 Lf);
Bordetella pertussis antigens: pertussis toxoid1 8 microgram, filamentous haemagglutinin1 8 microgram, pertactin1 2.5 microgram.
1Adsorbed on aluminium hydroxide hydrate (Al(OH)3) 0.3 mg Al3+, aluminium phosphate (AlPO4) 0.2 mg Al3+.
The manufacture of this product includes exposure to bovine derived 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.
No substances of human origin are used in its manufacture.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Boostrix is a turbid white suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older (see Section 4.2 Dose and Method of Administration).

4.2 Dose and Method of Administration

All parenteral drug and vaccine products should be inspected visually for any particulate matter or discolouration prior to administration. Before use of Boostrix, the vaccine should be well shaken to obtain a homogenous turbid suspension. Discard the vaccine if it appears otherwise.

Dosage.

Each dose consists of a 0.5 mL ready to use sterile suspension.

Administration.

Boostrix is administered by deep intramuscular injection, preferably in the deltoid region. The vaccine should never be administered intravenously.
Boostrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
This product is for use by one patient on a single occasion.
Any unused product or waste material should be disposed of in accordance with local requirements.
Boostrix can be given in accordance with current local recommendations for booster vaccination with reduced-content combined diphtheria-tetanus vaccine, when a booster against pertussis is desired.
Boostrix may be administered to adolescents with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis. Boostrix is not precluded in adult subjects with an incomplete, or no, history of previous pertussis vaccination. However, a booster response will only be elicited in adults who have been previously primed by vaccination or by natural infection (see Section 5.1 Pharmacodynamic Properties).

Tetanus prone injury.

In case of tetanus prone injury, Boostrix can be used as an alternative to adult type combined diphtheria tetanus in individuals with no history of tetanus toxoid within the preceding five years, if a booster against diphtheria and pertussis is additionally desired.
Boostrix can be used as an alternative to diphtheria tetanus in the management of tetanus prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine. If required, tetanus immunoglobulin may be administered concomitantly in accordance with official recommendations.

4.3 Contraindications

Boostrix should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines.
As with other vaccines, the administration of Boostrix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication.
Boostrix is contraindicated if the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria and tetanus vaccines.
Boostrix should not be administered to subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus (for convulsions or hypotonic hyporesponsive episodes, see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Boostrix should under no circumstances be administered intravenously.
It is good clinical practice that immunisation should be preceded by a review of the medical history (especially with regard to previous immunisation and possible occurrence of undesirable events) and a clinical examination.
If any of the following events have occurred in temporal relation to receipt of pertussis containing vaccines, the decision to give doses of pertussis containing vaccines should be carefully considered.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks, particularly since these events are not associated with permanent sequelae.
Temperature of ≥ 40.0°C within 48 hours of vaccination, not due to another identifiable cause.
Collapse or shock-like state (hypotonic hyporesponsive episode) within 48 hours of vaccination.
Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
Convulsions with or without fever, occurring within 3 days of vaccination.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) immunisation until the condition is corrected or stable. However, the decision to give pertussis vaccine must be made on an individual basis after careful consideration of the risks and benefits.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic reactions following the administration of the vaccine.
Boostrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
A history or a family history of convulsions and a family history of an adverse event following DTP vaccination do not constitute contraindications.
Human Immunodeficiency Virus (HIV) infection is not considered a contraindication for diphtheria, tetanus and pertussis (whole cell or acellular) immunisation. However in patients with immunodeficiency or in patients receiving immunosuppressive therapy, an adequate immunologic response may not be achieved. In these patients, when tetanus vaccine is needed for tetanus prone wound, plain tetanus vaccine should be used.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.4 Special Warnings and Precautions for Use.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use with other inactivated vaccines and with immunoglobulin is unlikely to result in interference with the immune responses.
If Boostrix is to be given at the same time as another injectable vaccine or immunoglobulin, the products should always be administered at different sites.
Boostrix must not be mixed with other vaccines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No human data are available. In combined fertility and embryofetal development studies in rats and rabbits, female fertility was unaffected by IM administration of Boostrix twice before mating with 2/5 x (rats) or 1 x (rabbits) the human dose.
(Category B1)
The use of Boostrix may be considered during the third trimester of pregnancy.
For data relating to the prevention of pertussis disease in infants born to women vaccinated during pregnancy, see Section 5.1 Pharmacodynamic Properties.
Safety data from a prospective observational study where Boostrix was administered to pregnant women during the third trimester (793 pregnancy outcomes) as well as data from postmarketing surveillance where pregnant women were exposed to Boostrix or to Boostrix-IPV (dTpa inactivated poliovirus vaccine) do not suggest any elevated frequency or unusual patterns of adverse events in pregnant women and their newborn child following pertussis vaccination.
Human data from prospective clinical studies on the use of Boostrix during the first and second trimester of pregnancy are not available.
Limited data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born from mothers vaccinated with Boostrix during pregnancy. The clinical relevance of this observation is unknown.
Combined embryofoetal development studies in which rats or rabbits were IM administered Boostrix twice before mating and several times during gestation (and once during lactation in rats) with 2/5 x (rats) or 1 x (rabbits) the human dose showed no effects on embryofoetal development, nor on postnatal development in rats.
Boostrix may be used during pregnancy when the possible advantages outweigh the possible risks for the foetus. When protection against tetanus is sought, consideration should be given to tetanus or combined diphtheria tetanus vaccines.
The safety of Boostrix when administered to breastfeeding women has not been evaluated.
It is unknown whether Boostrix is excreted in human breast milk.
Boostrix should only be used during breastfeeding when the possible advantages outweigh the potential risks.

4.7 Effects on Ability to Drive and Use Machines

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience.

The safety profile below is based on data from clinical trials where Boostrix was administered to 839 children (from 4 to 9 years of age) and 1931 adults, adolescents and children (above 10 years of age).
The adverse reactions are listed within body systems and are listed according to the following frequency: very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10,000 and < 1/1000; very rare: < 1/10,000.

Children from 4 to 9 years of age.

Infections and infestations.

Uncommon: upper respiratory tract infection.

Metabolism and nutrition disorders.

Common: anorexia.

Psychiatric disorders.

Very common: irritability.

Nervous system disorders.

Very common: somnolence.
Common: headache.
Uncommon: disturbances in attention.

Eye disorders.

Uncommon: conjunctivitis.

Gastrointestinal disorders.

Common: diarrhoea, vomiting, gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

Uncommon: rash.

General disorders and administration site conditions.

Very common: injection site reactions (including pain, redness and swelling), fatigue.
Common: fever ≥ 37.5°C (including fever > 39°C).
Uncommon: other injection site reactions (such as induration), pain.

Adults, adolescents and children from the age of 10 years onwards.

Infections and infestations.

Uncommon: upper respiratory tract infection, pharyngitis.

Blood and lymphatic system disorders.

Uncommon: lymphadenopathy.

Nervous system disorders.

Very common: headache.
Common: dizziness.
Uncommon: syncope.

Respiratory, thoracic and mediastinal disorders.

Uncommon: cough.

Gastrointestinal disorders.

Common: nausea, gastrointestinal disorders.
Uncommon: diarrhoea, vomiting.

Skin and subcutaneous tissue disorders.

Uncommon: hyperhidrosis, pruritus, rash.

Musculoskeletal and connective tissue disorders.

Uncommon: arthralgia, myalgia, joint stiffness, musculoskeletal stiffness.

General disorders and administration site conditions.

Very common: injection site reactions (including pain, redness and swelling), fatigue, malaise.
Common: fever ≥ 37.5°C, injection site reactions (such as injection site mass and injection site abscess sterile).
Uncommon: fever > 39°C, influenza-like illness, pain.
Data on 146 subjects suggests a small increase in local reactogenicity (pain, redness, swelling) with repeated vaccination according to a 0, 1, 6 months schedule in adults (> 40 years of age).
Subjects fully primed with 4 doses of DTPw followed by Boostrix dose around 10 years of age show an increase of local reactogenicity after an additional Boostrix dose administered 10 years later compared to after the first Boostrix dose.

Post-marketing experience.

Extremely rare cases of collapse or shock-like state (hypotonic hyporesponsiveness episode) and convulsions within 2 to 3 days of vaccination have been reported following DTPa and DTPa combination vaccines.

Blood and lymphatic system disorders.

Rare: angioedema.

Immune system disorders.

Very rare: allergic reactions, including anaphylactic and anaphylactoid reactions.

Nervous system disorders.

Rare: convulsions (with or without fever).

Skin and subcutaneous tissue disorders.

Rare: urticaria.

General disorders and administration site conditions.

Rare: extensive swelling of the vaccinated limb, asthenia.

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

Cases of overdose have been reported during post-marketing surveillance. Adverse events following overdosage, when reported, were similar to those reported with normal vaccine administration.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Boostrix (dTpa vaccine) induces antibodies against all vaccine antigens.

Clinical trials.

Immune response.

Immune response results to the diphtheria, tetanus and acellular pertussis components in four comparative studies (dTpa versus dT) of booster vaccination in different age groups are presented in Table 1.
Results of the comparative studies with commercial dT vaccines indicates that the degree and duration of protection would not be different from those obtained with these vaccines.
The GMT values for the three pertussis antigens following a booster dose of Boostrix to adolescents and adults are provided in Tables 2 and 3:
A pooled analysis of the immune response results to the diphtheria, tetanus and acellular pertussis components from 15 comparative and noncomparative clinical studies are presented in Table 4 (children 4-9 years of age) and Table 5 (adults and adolescents above 10 years of age). Approximately one month following booster vaccination with Boostrix, the following seroprotection/ seropositivity rates were observed.

Efficacy in protecting against pertussis.

There is currently no correlate of protection defined for pertussis; however, the protective efficacy of GlaxoSmithKline Biologicals' DTPa (Infanrix) vaccine against WHO defined typical pertussis (≥ 21 days of paroxysmal cough with laboratory confirmation) was demonstrated in the following 3 dose primary studies.

A prospective blinded household contact study performed in Germany (3, 4, 5 months schedule).

Based on data collected from secondary contacts in households where there was an index case with typical pertussis, the protective efficacy of the vaccine was 88.7%. Protection against laboratory confirmed mild disease, defined as 14 days or more of cough of any type was 73% and 67% when defined as 7 days or more of cough of any type.

An NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule).

The vaccine efficacy was found to be 84%. When the definition of pertussis was expanded to include clinically milder cases with respect to type and duration of cough, the efficacy of Infanrix was calculated to be 71% against > 7 days of any cough and 73% against > 14 days of any cough. In a follow-up of the same cohort, the efficacy was confirmed up to 5 years after completion of primary vaccination without administration of a booster dose of pertussis.
The study assessed duration of protection of Infanrix given in a 3 dose schedule to infants. A similar duration of protection cannot be assumed to apply to older children or adults given a single dose of Boostrix, regardless of previous vaccination against pertussis.
Although the protective efficacy of Boostrix has not been demonstrated in adolescents and adult age groups, vaccinees in these age groups who received Boostrix achieved antipertussis antibody titres greater than those in the German household contact study where the protective efficacy of Infanrix was 88.7%.
There are currently no data which demonstrate a reduction of transmission of pertussis after immunisation with Boostrix. However, it could be expected that immunisation of immediate close contacts of newborn infants, such as parents, grandparents and healthcare workers, childcare workers, would reduce exposure of pertussis to infants not yet adequately protected through immunisation.

Effectiveness in the protection against pertussis disease in infants born to women vaccinated during pregnancy.

Boostrix or Boostrix-IPV vaccine effectiveness (VE) was evaluated in three observational studies, in UK, Spain and Australia. The vaccine was used during the third trimester of pregnancy to protect infants below 3 months of age against pertussis disease, as part of a maternal immunisation programme.
Details of each study design and results are provided in Table 6.
If maternal vaccination occurs within two weeks before delivery, VE in the infant may be lower than the figures in Table 6.

Persistence of the immune response.

The following responses for diphtheria, tetanus and pertussis were observed 3 to 3.5 years and 5 years following vaccination with Boostrix in children (Table 7):
The following responses for diphtheria, tetanus and pertussis were observed 3 to 3.5 years, 5 years and 10 years following vaccination with Boostrix in adolescents (Table 8) and adults (Table 9):

Immune response in subjects with unknown/incomplete/no primary vaccination history.

Adolescents.

After administration of one dose of Boostrix to 83 adolescents aged from 11 to 18 years, without previous pertussis vaccination and no vaccination against diphtheria and tetanus in the previous 5 years, all subjects were seroprotected against tetanus and diphtheria. The seropositivity rate after one dose varied between 87% and 100% for the different pertussis antigens.

Adults.

After administration of one dose of Boostrix to 139 adults ≥ 40 years of age that had not received any diphtheria and tetanus containing vaccine in the past 20 years, more than 98.5% of adults were seropositive for all three pertussis antigens and 81.5% and 93.4% were seroprotected against diphtheria and tetanus respectively. After administration of two additional doses one and six months after the first dose, the seropositivity rate was 100% for all three pertussis antigens and the seroprotection rates for diphtheria and tetanus reached 99.3% and 100% respectively. While the study included patients who had either not received vaccination against pertussis or had received pertussis vaccination more than 40 years before, almost all subjects were positive for anti-FHA and anti-PT antibodies and approximately half were positive to anti-PRN antibodies at baseline.

Immune response after a repeat dose of Boostrix.

The immunogenicity of Boostrix, administered 10 years after a previous booster dose with Boostrix or reduced-antigen content diphtheria, tetanus and acellular pertussis vaccines has been evaluated in adults. One month after the decennial Boostrix dose, > 99% of subjects were seroprotected against diphtheria and tetanus and all were seropositive for antibodies against pertussis antigens PT, FHA and PRN.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Boostrix has not been evaluated for genotoxicity.

Carcinogenicity.

Boostrix has not been evaluated for carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine (dTpa) components are adsorbed on 0.5 mg aluminium and suspended in isotonic sodium chloride. It also contains formaldehyde, polysorbate 80 and glycine in residual amounts.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Boostrix should be stored in a refrigerator (2°C - 8°C). Do not freeze. Discard if vaccine has been frozen. Protect from light.

6.5 Nature and Contents of Container

Boostrix is presented as a turbid white suspension in a glass vial or glass prefilled syringe. Upon storage a white deposit and clear supernatant can be observed.
This is a normal finding.
The vials and prefilled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.
Not all pack sizes and presentations may be distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Not relevant to vaccines.

CAS number.

Not relevant to vaccines.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes