BOOSTRIX-IPV

MIMS Revision Date: 01 May 2025

1 Name of Medicine

Combined diphtheria, tetanus, acellular pertussis (dTpa) and inactivated poliovirus vaccine.

2 Qualitative and Quantitative Composition

Boostrix-IPV is a sterile suspension for injection which contains diphtheria toxoid (D), tetanus toxoid (T), three purified antigens of Bordetella pertussis [pertussis toxoid (PT), pertussis filamentous haemagglutinin (FHA) and pertactin (PRN)] and three types of inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3: Saukett strain).
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;
Inactivated poliovirus: Type 1 (Mahoney strain)² 40 D-antigen unit, Type 2 (MEF-1 strain)² 8 D-antigen unit, Type 3 (Saukett strain)² 32 D-antigen unit.
¹ Adsorbed on aluminium hydroxide, hydrate (Al(OH)₃) 0.3 mg Al³⁺, and aluminium phosphate (AlPO₄) 0.2 mg Al³⁺.
² Propagated in Vero cells.
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.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Boostrix-IPV is a turbid white suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Boostrix-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis and polio of individuals from the age of four years onwards.
Boostrix-IPV is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see Section 4.2 Dose and Method of Administration; Section 4.6 Fertility, Pregnancy and Lactation; Section 5.1 Pharmacodynamic Properties).
The use of Boostrix-IPV should be in accordance with official recommendations.
Clinical data has demonstrated that in adults with an unknown history of pertussis vaccination, the majority had an immunogenic response to pertussis when given Boostrix-IPV (see Section 5.1 Pharmacodynamic Properties).
Finally, all adults who reach the age of 50 years without having received a boosting dose of dT in the previous 5 years should receive a further boosting dose of dT, where the adult/ adolescent formulation dTpa can be used instead.
Boostrix-IPV is not intended for primary immunisation.

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-IPV, the vaccine should be well shaken to obtain a homogenous turbid suspension. Do not administer the vaccine if it appears otherwise. The vaccine should be administered immediately after opening.
Dosage. A single 0.5 mL dose may be administered from the age of four years onwards.
Booster vaccination with Boostrix-IPV should be performed as per official recommendations.
Boostrix-IPV can be administered to pregnant women during the second or the third trimester of pregnancy in accordance with official recommendations (see Section 4.1 Therapeutic Indications; Section 4.6 Fertility, Pregnancy and Lactation; Section 5.1 Pharmacodynamic Properties). Refer to the Australian Immunisation Handbook for further guidance.
Administration. Boostrix-IPV is administered by deep intramuscular injection preferably in the deltoid region of the arm (see Section 4.4 Special Warnings and Precautions for Use).
Boostrix-IPV is for use in one patient on one occasion only. Contains no antimicrobial preservative. Any unused product or waste material should be disposed of in accordance with local requirements.
Boostrix-IPV vaccine should never be administered intravenously.
Individuals with an incomplete, or no, history of a primary series of diphtheria and tetanus toxoids should not be vaccinated with Boostrix-IPV. Boostrix-IPV is not precluded in subjects with an incomplete, or no, history of previous pertussis or polio vaccination. However, a booster response will only be elicited in individuals who have been previously primed by vaccination or by natural infection.
Tetanus prone injury. In case of tetanus prone injury, Boostrix-IPV 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, pertussis and polio is desired in addition to tetanus.
Boostrix-IPV can be used as an alternative to adult type 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.
Instructions for the pre-filled syringe.
1. Hold the syringe by the barrel and not the plunger.
2. Unscrew the syringe cap by twisting it anticlockwise.
3. To attach a needle, connect the hub to the Luer Lock Adaptor and rotate a quarter turn clockwise until you feel it lock.
4. Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.

4.3 Contraindications

Boostrix-IPV should not be administered to subjects having known hypersensitivity or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or inactivated polio vaccines or to any component of the vaccine.
Boostrix-IPV is contraindicated if the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with a pertussis containing vaccine. In these circumstances, pertussis vaccination should be discontinued, and the vaccination should be continued with diphtheria-tetanus and polio vaccines.
Boostrix-IPV should not be administered to subjects who have experienced 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-IPV should under no circumstances be administered intravascularly.
It is good clinical practice that immunisation should be preceded by a review of the medical history (especially with regards to previous immunisation and possible occurrence of undesirable events) and a clinical examination.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
If any of the following events are known to have occurred in temporal relation to receipt of pertussis containing vaccines, the decision to give further doses of vaccine containing the pertussis component should be carefully considered. There may be circumstances, such as a high incidence of pertussis, when the potential benefits of vaccination outweigh the 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.
A history of febrile convulsions, a family history of convulsions, a family history of sudden infant death syndrome (SIDS) or a family history of an adverse event following DTPa and/or IPV vaccination do not constitute contraindications.
As with other vaccines, the administration of Boostrix-IPV should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication.
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.
Boostrix-IPV should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. If in accordance with official recommendations, the vaccine may need to be administered subcutaneously to these subjects. With both routes of administration, firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
Boostrix-IPV contains traces of neomycin sulfate and polymyxin sulfate. The vaccine should be used with caution in patients with known hypersensitivity to either of these antibiotics.
Human immunodeficiency virus (HIV) infection is not considered a contraindication to Boostrix-IPV vaccination. However, in patients with immunodeficiency or in patients receiving immunosuppressive therapy, the expected immunologic response may not be achieved. No data currently exist on use of Boostrix-IPV in these patients.
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-IPV is to be given at the same time as another injectable vaccine or immunoglobulin, the products should always be administered at different sites.
As with other vaccines, patients receiving immunosuppressive therapy or patients with immunodeficiency may not achieve an adequate response.
Boostrix-IPV should not be mixed with other vaccines in the same syringe.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No human data are available. In combined fertility and embryofetal development studies in rats or rabbits, female fertility was unaffected by IM administration of Boostrix-IPV twice before mating with 2/5x (rats) or 1x (rabbits) the human dose.
Use in pregnancy. (Category A)
Boostrix-IPV can be used during the second or third trimester of pregnancy in accordance with official recommendations (see Section 4.1 Therapeutic Indications). Refer to the Australian Immunisation Handbook for further guidance.
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 randomised controlled clinical trial (341 pregnancy outcomes) and from a prospective observational study (793 pregnancy outcomes) where Boostrix (dTpa component of Boostrix-IPV) was administered to pregnant women during the third trimester have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child.
Safety data from prospective clinical studies on the use of Boostrix-IPV or Boostrix during the first and second trimester of pregnancy are not available.
Data from post-marketing surveillance where pregnant women were exposed to Boostrix-IPV or to Boostrix in the second or the third trimester have not detected an elevated frequency or unusual patterns of adverse events.
As with other inactivated vaccines, it is not expected that vaccination with Boostrix-IPV harms the foetus at any trimester of pregnancy.
Although lower concentrations of antibodies against some pertussis antigens were observed post primary and post booster vaccination in infants and toddlers born to mothers vaccinated with Boostrix during pregnancy, clinical data demonstrated such immune interferences to be non-clinically relevant. The lower antibody concentrations did not prevent effective priming of the immune system of infants born to Boostrix-vaccinated mothers as indicated by the establishment of a strong booster response against all vaccine antigens by the age of 11-18 months.
Combined embryo foetal development studies in which rats or rabbits were IM administered Boostrix-IPV twice before mating and several times during gestation (and once during lactation in rats) with 2/5x (rats) or 1x (rabbits) the human dose showed no effects on embryofetal development in either species, nor on postnatal development in rats. Similarly, no effects on embryofetal development were observed in rats IM administered Infanrix-IPV once prior to gestation and Boostrix-IPV (1/5x the human dose) 4 times during gestation.
When protection against tetanus is sought, consideration should be given to tetanus or combined diphtheria-tetanus vaccines.
Use in lactation. The safety of Boostrix-IPV when administered to breastfeeding women has not been evaluated.
It is unknown whether Boostrix-IPV is excreted in human breast milk.
Boostrix-IPV should only be used during breastfeeding when the possible advantages outweigh the potential risks.
Animal reproduction studies in rats have shown that offspring of dams boosted with 1/5 the human dose (based on volume) of Boostrix-IPV during pregnancy have higher serum titres on lactation day 25 than lactation day 4, suggesting maternal transfer of antibodies by milk during lactation.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience. The safety profile presented below is based on data from clinical trials where Boostrix-IPV was administered to 908 children (from 4 to 9 years of age) and 955 adults, adolescents and children (above 10 years of age). The most common events occurring after vaccine administration in both groups were local injection site reactions (pain, redness and swelling). These had their onset within the first day after vaccination. All resolved without sequelae.
The adverse events 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. Blood and lymphatic system disorders. Uncommon: lymphadenopathy.
Gastrointestinal disorders. Uncommon: diarrhoea, vomiting, abdominal pain, nausea.
General disorders and administration site conditions. Very common: injection site reactions (including pain, redness and swelling).
Common: fever ≥ 37.5°C (including fever > 39°C), injection site reactions (such as haemorrhage).
Uncommon: fatigue.
Metabolism and nutrition disorders. Common: anorexia.
Nervous system disorders. Very common: somnolence.
Common: headache.
Psychiatric disorders. Common: irritability.
Uncommon: sleep disorder, apathy.
Respiratory, thoracic and mediastinal disorders. Uncommon: dry throat.
Adults, adolescents and children from the age of 10 years onwards. Blood and lymphatic system disorders. Uncommon: lymphadenopathy.
Gastrointestinal disorders. Common: gastrointestinal disorders (nausea, vomiting, diarrhoea and/or abdominal pain).
General disorders and administration site conditions. Very common: injection site reactions (including pain, redness and swelling), fatigue.
Common: fever ≥ 37.5°C, injection site reactions (such as haematoma).
Uncommon: fever > 39°C, chills, pain.
Infections and infestations. Uncommon: oral herpes.
Metabolism and nutrition disorders. Uncommon: decreased appetite.
Musculoskeletal and connective tissue disorders. Uncommon: myalgia, arthralgia.
Nervous system disorders. Very common: headache.
Uncommon: paraesthesia, somnolence, dizziness.
Respiratory, thoracic and mediastinal disorders. Uncommon: asthma.
Skin and subcutaneous tissue disorders. Uncommon: pruritus.
The following adverse reactions were additionally reported during clinical trials with GlaxoSmithKline's other reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix) 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):
Children from 4 to 9 years of age. Eye disorders. Uncommon: conjunctivitis.
Gastrointestinal disorders. Common: gastrointestinal disorders (nausea, vomiting, diarrhoea and/or abdominal pain).
General disorders and administration site conditions. Uncommon: injection site reactions (such as induration), pain.
Infections and infestations. Uncommon: upper respiratory tract infection.
Nervous system disorders. Uncommon: disturbances in attention.
Skin and subcutaneous tissue disorders. Uncommon: rash.
Adults, adolescents and children from the age of 10 years onwards. Gastrointestinal disorders. Common: nausea.
Uncommon: diarrhoea, vomiting.
General disorders and administration site conditions. Very common: malaise.
Common: injection site reactions (such as injection site mass and injection site abscess sterile).
Uncommon: influenza-like illness.
Infections and infestations. Uncommon: upper respiratory tract infection, pharyngitis.
Musculoskeletal and connective tissue disorders. Uncommon: joint stiffness, musculoskeletal stiffness.
Nervous system disorders. Uncommon: syncope.
Respiratory, thoracic and mediastinal disorders. Uncommon: cough.
Skin and subcutaneous tissue disorders. Uncommon: hyperhidrosis, rash.
Collapse or shock-like state (hypotonic-hyporesponsive episode) and convulsions have been reported very rarely following immunisation of children with products containing one or more of the antigenic constituents of Boostrix-IPV.
Reactogenicity after a repeat dose of Boostrix-IPV or Boostrix. Subjects fully primed with 4 doses of DTPa followed by Boostrix-IPV at around 4-8 years of age show no increased reactogenicity after the second Boostrix-IPV dose administered 5 years later.
Subjects fully primed with 4 doses of DTPw followed by a Boostrix-IPV around 10 years of age show an increase of local reactogenicity after an additional Boostrix dose administered 10 years later.
Post-marketing surveillance. 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, injection site induration.
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 postmarketing 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. More than 1500 vaccinees have received a dose of Boostrix-IPV in clinical studies conducted in children (4 to 8 years of age), adolescents (10 to 14 years of age) and adults (> 14 years of age). The children were previously primed with 4 doses of DTPa and at least 3 doses of OPV or IPV, the adolescents with DTPw and the recommended local schedule for polio, and the adults had a variable immunisation history but all had received a primary course of diphtheria and tetanus vaccination. One month postvaccination with Boostrix-IPV, immune responses in 1469 subjects were the following.
Immune response to the D and T components. 100% of children and adolescents (< 18 years) had antibody titres of ≥ 0.1 IU/mL for both antigens. 86.8% of subjects ≥ 18 years achieved antibody levels against D of ≥ 0.016 IU/mL (by ELISA ± Vero cell testing), and 99.6% achieved antibody levels against T of ≥ 0.1 IU/mL (by ELISA). For both diphtheria and tetanus, serum antibody levels ≥ 0.01 IU/mL are considered protective.
Immune response to the Pa component. A total of 97.5% of subjects were seropositive for antibodies to all Pa components (PT, FHA or PRN) (ELISA, cut off 5 EL.U/mL). The vaccine response rates (> two-fold rise in antibody titres, or ≥ the cut off in initially seronegative subjects) after Boostrix-IPV were > 94% for PT and PRN, and > 90% for FHA.
Protective efficacy of the Pa component. There is currently no serological correlate of protection defined for pertussis; however, the protective efficacy of GSK's 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%.
An NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule). The vaccine efficacy was found to be 84%. In a follow-up of the same cohort, efficacy persisted undiminished up to 5 years after completion of primary vaccination without administration of a booster dose against pertussis.
This 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-IPV, regardless of previous vaccination against pertussis.
Although the protective efficacy of Boostrix-IPV has not been demonstrated in adolescents and adult age groups, vaccinees in these age groups who received Boostrix-IPV 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-IPV. However, it could be expected that immunisation of immediate close contacts of newborn infants, such as parents, grandparents, healthcare workers and childcare workers would reduce exposure of pertussis to infants not yet adequately protected through immunisation.
Immune response to the IPV component. More than 99% of subjects had antibody titres ≥ 8 for all three polio serotypes one month after a booster dose of Boostrix-IPV.
Antibody titres ≥ 8 are deemed to correlate with protection against polio. See Tables 1, 2 and 3.

Tetanus antibody response in the first 10 days following vaccination. Antitetanus toxoid antibodies were measured 10 days after vaccination in a subset of subjects aged 18 years and over in a study in Germany.
Seroprotective antibody concentrations (≥ 0.1 IU/mL) were observed in 95.1% of the subjects having received Boostrix-IPV, 96.5% of the subjects having separate injections of Boostrix and IPV and 92.1% of subjects having received a licensed Td-IPV vaccine. There thus did not appear to be any significant difference between Boostrix-IPV and the two control groups.
Passive protection against pertussis in infants (below 3 months of age) born to mothers vaccinated during pregnancy. In a randomised, cross-over, placebo-controlled study, higher pertussis antibody concentrations were demonstrated at delivery in the cord blood of babies born to mothers vaccinated with Boostrix (N = 291) versus placebo (N = 292) during the third trimester of pregnancy. The concentrations of antibodies against the pertussis antigens PT, FHA and PRN were respectively 8, 16 and 21 times higher in the cord blood of babies born to vaccinated mothers versus controls. These antibody titres may provide passive protection against pertussis, as shown by observational effectiveness studies.
Immunogenicity in infants and toddlers born to mothers vaccinated during pregnancy. In follow-up trials in more than 500 infants and toddlers born to vaccinated mothers, clinical data did not show clinically relevant interference between maternal vaccination with Boostrix and the infant and toddler response to diphtheria, tetanus, hepatitis B, inactivated polio virus, Haemophilus influenzae type b or pneumococcal antigens. Although lower concentrations of antibodies against some pertussis antigens were observed post primary and post booster vaccination, 92.1 - 98.1% of subjects born to vaccinated mothers showed a booster response against all pertussis antigens. Current epidemiological data on pertussis disease do not suggest any clinical relevance of this immune interference.
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 vaccination programme.
Details of each study design and results are provided in Table 4.
If maternal vaccination occurs within two weeks before delivery, VE in the infant may be lower than the figures in the table.
Boostrix-IPV-persistence of immunity to diphtheria, tetanus, pertussis and polio. A total of 344 children vaccinated with Boostrix-IPV between 4 and 8 years of age, had antibody persistence five years later as shown in Table 5.
Boostrix-IPV vaccination with a second dose. The immunogenicity of Boostrix-IPV, administered 5 years after a previous booster dose of Boostrix-IPV at 4 to 8 years of age, has been evaluated. One month postvaccination, > 99% of participants were seropositive against pertussis and seroprotected against diphtheria, tetanus and all three polio types.
Boostrix (dTpa component of Boostrix-IPV) - persistence of immunity to diphtheria, tetanus and pertussis. The following responses for diphtheria, tetanus and pertussis were observed 3 to 3.5 years, 5 years and 10 years following vaccination with Boostrix (dTpa component of Boostrix-IPV) in adolescents (see Table 6) and adults (see Table 7).
Boostrix (dTpa component of Boostrix-IPV), vaccination with a second dose. The immunogenicity of Boostrix (dTpa component of Boostrix Polio), administered 10 years after a first booster dose with Boostrix or reduced-antigen content diphtheria, tetanus and acellular pertussis vaccines has been evaluated in adolescents and adults. One month postvaccination, > 99% of participants were seroprotected against diphtheria and tetanus and all were seropositive against pertussis.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity. Boostrix-IPV has not been evaluated for genotoxicity.
Carcinogenicity. Boostrix-IPV has not been evaluated for carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The final vaccine also contains aluminium hydroxide hydrate and aluminium phosphate as adjuvants, sodium chloride, medium 199, water for injections, and traces of polysorbate 80, neomycin sulfate and polymyxin B sulfate.

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-IPV should be stored in a refrigerator (2°C-8°C). Do not freeze. Discard if vaccine has been frozen. Protect from light.
Upon storage, a white deposit and clear supernatant can be observed. This is a normal finding.

6.5 Nature and Contents of Container

0.5 mL of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) with a rubber tip cap. The tip cap and rubber plunger stopper are not made with natural rubber latex.
Pack size. 1, 10.
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.

Date of First Approval

08 July 2004

Date of Revision

05 March 2025

Summary Table of Changes