Infanrix
Brand Information
| Brand name | Infanrix |
| Active ingredient | Diphtheria toxoid + Tetanus toxoid + Pertussis vaccine |
| Schedule | S4 |
Consumer Medicine Information (CMI) leaflet
Please read this leaflet carefully before you start using the Infanrix.
Summary CMI
INFANRIX
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about your child being given this vaccine, speak to your doctor, nurse or pharmacist.
1. Why is your child being given INFANRIX?
INFANRIX is used to prevent three diseases: diphtheria, tetanus and pertussis (whooping cough). The vaccine is sometimes called DTPa vaccine. INFANRIX contains the active ingredients of non-infectious substances from diphtheria bacteria, tetanus bacteria and purified proteins of pertussis bacteria.
For more information, see Section 1. Why is your child being given INFANRIX? in the full CMI.
2. What should you know before your child is given INFANRIX?
Your child should not be given this vaccine if they have ever had an allergic reaction to INFANRIX or any of the ingredients listed at the end of the CMI.
Talk to your doctor or nurse if your child has any other medical conditions or takes any other medicines.
For more information, see Section 2. What should you know before your child is given INFANRIX? in the full CMI.
3. What if your child is taking other medicines?
Some medicines may interfere with INFANRIX and affect how it works.
A list of these medicines is in Section 3. What if your child is taking other medicines? in the full CMI.
4. How is INFANRIX given?
- INFANRIX will be injected into the upper leg muscle or the upper arm muscle. For children with bleeding problems, the dose may need to be given under the skin (subcutaneously). The vaccine should never be injected into a vein (intravenously).
- A primary course of INFANRIX is generally given as a total of three doses. Each dose is given on a separate visit. The first dose of INFANRIX is given at 2 months of age. The second and third doses are given every 2 months, at 4 and 6 months of age.
- A fourth dose of INFANRIX may also be given at 18 months of age and a fifth dose at 4 to 6 years of age to children who have previously been immunised with 3 or 4 doses of INFANRIX or another brand of diphtheria, tetanus and pertussis-containing vaccine. It is important to return at the recommended times for follow up doses.
More instructions can be found in Section 4. How is INFANRIX given? in the full CMI.
5. What should you know while your child is being given INFANRIX?
| Things you should do |
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| Looking after your vaccine |
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For more information, see Section 5. What should you know while your child is being given INFANRIX? in the full CMI.
6. Are there any side effects?
Most unwanted effects with INFANRIX are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site. Side effects that have been reported include pain, redness and swelling where the injection was given, feeling irritable, feeling tired, fever of 38°C or higher, loss of appetite, unusual crying, feeling restless, being sick (vomiting), diarrhoea, itchy skin and pain and swelling larger than 5 cm where the injection was given. For more information, including what to do if your child has any side effects, see Section 6. Are there any side effects? in the full CMI.
Full CMI
INFANRIX
Active ingredients: diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin and pertactin
Consumer Medicine Information (CMI)
This leaflet provides important information about INFANRIX. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about your child being given INFANRIX.
Where to find information in this leaflet:
1. Why is your child being given INFANRIX?
2. What should you know before your child is given INFANRIX?
3. What if your child is taking other medicines?
4. How is INFANRIX given?
5. What should you know while your child is being given INFANRIX?
6. Are there any side effects?
7. Product details
1. Why is your child being given INFANRIX?
INFANRIX contains the active ingredients of non-infectious substances from diphtheria bacteria, tetanus bacteria and purified proteins of pertussis bacteria. The vaccine is sometimes called the DTPa vaccine.
INFANRIX is used to prevent three diseases, diphtheria, tetanus and pertussis (whooping cough). The vaccine cannot cause these diseases.
Diphtheria, tetanus and pertussis are all serious life-threatening diseases caused by bacterial infection.
The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
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 three diseases. INFANRIX cannot give your child diphtheria, tetanus or pertussis infection. The vaccine will not protect against diseases caused by other types of bacteria or organisms.
2. What should you know before your child is given INFANRIX?
Warnings
Your child should not be given INFANRIX if:
- they are allergic to any of the ingredients listed at the end of this leaflet
- they have had an allergic reaction to any other diphtheria, tetanus or pertussis containing vaccine (such as Triple Antigen (DTPa) vaccine)
- they have had INFANRIX before and became unwell. Tell your doctor, nurse or pharmacist before the next dose is given
- they have experienced a disease of the brain within 7 days after previous vaccination with a pertussis containing vaccine
- they have 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
- the expiry date printed on the pack has passed
- the packaging is torn or shows signs of tampering.
Check with your doctor or nurse if your child:
- has any other medical conditions such as:
- a brain disease or a central nervous system (CNS) disease (e.g. epilepsy)
- a bleeding problem or bruises easily
- lowered immunity due to medical treatment or a medical condition
- encephalopathy (a disease of the brain)
- a family history of seizures/fits - has experienced any problems after having INFANRIX or other diphtheria, tetanus, pertussis containing vaccines (such as Triple Antigen (DTPa) vaccine), especially:
- a high temperature (over 40.5°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 - has allergies to any other medicines or substances, such as dyes, foods or preservatives
- has received another vaccine recently, or is having any prescription or OTC (over-the-counter) medicines. In particular, mention to your doctor if your child is being given medicines which suppress the immune system, such as high-dose steroids.
If you are not sure whether your child should be given INFANRIX, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for your child.
If your child was born very prematurely, please discuss with your doctor or nurse. In infants born very prematurely (before or at 28 weeks of pregnancy) breathing difficulties may be more common in the first three days following vaccination.
Fainting can occur following, or even before, any needle injection, therefore, tell the doctor or nurse if your child has fainted with a previous injection.
During treatment, 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 your child is taking other medicines?
Tell your doctor, nurse 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.
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 INFANRIX is to be given with another vaccine or medicine.
4. How is INFANRIX given?
The doctor or nurse will give INFANRIX as an injection.
If you have any concerns about how this vaccine is to be given, talk to your doctor or nurse.
How much is given
- The dose of INFANRIX is 0.5 mL.
When is it given
- A primary course of INFANRIX is generally given as a total of three doses. Each dose is given on a separate visit.
- The first dose of INFANRIX is given at 2 months of age. The second and third doses are given every 2 months, at 4 and 6 months of age.
- A fourth dose of INFANRIX may also be given at 18 months of age and a fifth dose at 4 to 6 years of age to children who have previously been immunised with 3 or 4 doses of INFANRIX or another brand of diphtheria, tetanus and pertussis-containing vaccine.
How is it given
- INFANRIX is injected into the upper leg muscle or the upper arm muscle. For infants and children with bleeding problems, the dose may need to be given under the skin (subcutaneously).
- The vaccine should never be injected into a vein (intravenously).
- It is important to return at the recommended times for follow up doses.
If your child misses a dose of INFANRIX
If your child misses a scheduled dose, talk to your doctor or nurse and arrange another visit as soon as possible.
If your child is given too much INFANRIX
If you think that your child has been given too much INFANRIX, your child may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should you know while your child is being given INFANRIX?
Things you should do
Keep your child's follow up visits with the doctor or clinic. It is important that follow-up doses of INFANRIX are given at the correct times. This will ensure the best effect of the vaccine in protecting your child against diphtheria, tetanus and pertussis infection.
Remind any doctor or pharmacist you visit that your child has recently received INFANRIX.
Looking after your vaccine
INFANRIX is usually stored at the doctor's clinic or surgery, or at the pharmacy. But if you need to store INFANRIX:
- keep it in the refrigerator between 2°C and 8°C
- THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE
- keep INFANRIX in the original pack until it is time for it to be given.
Follow the instructions on the carton on how to take care of your vaccine properly.
Keep it where young children cannot reach it.
Getting rid of any unwanted vaccine
If you no longer need 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 vaccines can have side effects. If your child does experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.
Less serious side effects
| Less serious side effects | What to do |
General disorders and administration site conditions:
| Speak to your doctor if your child has any of these less serious side effects and they worry you. |
Serious side effects
| Serious side effects | What to do |
Immune system disorders and allergic reactions:
| 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, nurse 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 people.
Do not be alarmed by this list of possible side effects. Your child may not experience any of them.
Reporting side effects
After you have received medical advice for any side effects your child has 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 any of your child's medicines.
7. Product details
This vaccine is only available with a doctor's prescription.
What INFANRIX contains
| Active ingredients (main ingredients) |
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| Other ingredients (inactive ingredients) |
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Your child should not be given this vaccine if they are allergic to any of these ingredients.
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.
What INFANRIX looks like
INFANRIX is a white, slightly milky liquid available in prefilled syringes (AUST R 142370).
Who distributes INFANRIX
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria, 3067
Phone: 1800 033 109
www.gsk.com.au
Trade marks are owned by or licensed to the GSK group of companies.
©2025 GSK group companies or its licensor.
This leaflet was prepared on 29 August 2025.
Version 6.0
Brand Information
| Brand name | Infanrix |
| Active ingredient | Diphtheria toxoid + Tetanus toxoid + Pertussis vaccine |
| Schedule | S4 |
MIMS Revision Date: 01 September 2023
1 Name of Medicine
Diphtheria-tetanus-acellular pertussis (DTPa) vaccine.
2 Qualitative and Quantitative Composition
Infanrix DTPa vaccine is a sterile suspension which contains diphtheria toxoid, tetanus toxoid and three purified antigens of Bordetella pertussis [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)] adsorbed onto aluminium hydroxide hydrate.
The diphtheria and tetanus toxins are obtained from cultures of Corynebacterium diphtheriae and Clostridium tetani and are then detoxified and purified. The acellular pertussis vaccine components (PT, FHA and PRN) are extracted from phase I Bordetella pertussis, and are then purified and stabilised.
Each 0.5 mL dose of Infanrix contains not less than 30 IU of diphtheria toxoid, 40 IU of tetanus toxoid, 25 microgram of PT, 25 microgram of FHA and 8 microgram of PRN.
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.
Infanrix meets the World Health Organisation requirements for biological substances and for diphtheria and tetanus vaccines. No substances of human origin are used in its manufacture.
List of excipients with known effect. For the full list of excipients, see Section 6.1 List of Excipients.
3 Pharmaceutical Form
Suspension for injection.
Turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed.
4 Clinical Particulars
4.1 Therapeutic Indications
Infanrix (DTPa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age.
Infanrix (DTPa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.
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 Infanrix, the vaccine should be well shaken to obtain a homogenous turbid suspension. Discard the vaccine if it appears otherwise.
As stated in Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Infanrix can be mixed in the same syringe with Hiberix or Act-HIB. In this case, the diluent supplied in the Hiberix or Act-HIB package is replaced by Infanrix.
From the Hiberix or Act-HIB package, discard the vial containing the diluent. The combined vaccine must be reconstituted by adding the entire contents of the Infanrix container to the vial containing the lyophilised powder.
The extemporaneous mix should be handled in the same way as the Infanrix vaccine.
Instructions for the pre-filled syringe. Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by twisting it anticlockwise.
To attach the needle, connect the hub to the Luer lock adaptor and rotate a quarter turn clockwise until you feel it lock.
Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.
Dosage. Each dose consists of a 0.5 mL ready to use sterile suspension.
Administration. Infanrix is administered by intramuscular injection. The vaccine should never be administered intravenously.
Infanrix should be injected intramuscularly in the lateral aspect of the thigh or the deltoid region of the arm. The recommended dose (0.5 mL) of vaccine must be administered.
The primary immunisation course consists of 3 doses at 2, 4 and 6 months of age with a fourth dose at 18 months of age and a fifth dose at 4 to 6 years of age.
Infanrix can also be used as the fourth and/or fifth dose for children 18 months of age and 4 to 6 years of age, who have previously been immunised with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.
Further guidance regarding the use of vaccines can be found in the Australian Immunisation Handbook (see Section 5.1 Pharmacodynamic Properties, Clinical trials for schedules evaluated in clinical trials).
4.3 Contraindications
Infanrix should not be administered to subjects with known hypersensitivity to any components of the vaccine, and should not be administered to subjects having shown signs of hypersensitivity after previous administration of Infanrix, diphtheria and tetanus vaccine and DTPw.
As with other vaccines, the administration of Infanrix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication.
Infanrix is contraindicated if the child has experienced an encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccination course should be continued with diphtheria and tetanus vaccine.
4.4 Special Warnings and Precautions for Use
Infanrix 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 DTPw or DTPa the decision to give subsequent doses of Infanrix, containing the pertussis component, 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 ≥ 40.5°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) immunization 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.
A history of febrile convulsions and a family history of convulsive fits do not constitute contraindications. Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days postvaccination.
Acute encephalopathy has been reported rarely (estimated rate 0-10.5 cases per million vaccinations) following whole cell DTP vaccination; however a causal relationship has not been established. No such cases have been reported to date with acellular DTP vaccines.
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.
Infanrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
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. No data currently exist on use of Infanrix in these patients.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunization 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.
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.
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
Infanrix was administered simultaneously with other paediatric vaccines (e.g. Hib and oral polio) in some studies during the clinical trial programme, however immune responses to the other vaccines were not assessed.
Infanrix can be mixed in the same syringe with Hiberix or Act-HIB. Different injectable vaccines should always be administered at different injection sites.
4.6 Fertility, Pregnancy and Lactation
Effects on fertility. No data available.
Use in pregnancy. (Category B2)
As Infanrix is not intended for use in adults, adequate human data on use during pregnancy and adequate animal reproduction studies are not available.
Use in lactation. As Infanrix is not intended for use in adults, adequate human data on use during lactation and adequate animal reproduction studies are not available.
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 more than 11,400 subjects.
As has been observed for DTPa and DTPa containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix with respect to the primary course.
Frequencies per dose are defined as follows: very common: ≥ 10%; common: ≥ 1% and < 10%; uncommon: ≥ 0.1% and < 1%; rare: ≥ 0.01% and < 0.1%; very rare: < 0.01%.
Blood and lymphatic system disorders. Very rare: lymphadenopathy1.
Metabolism and nutrition disorders. Common: appetite lost2.
Psychiatric disorders. Very common: irritability.
Common: restlessness2, crying abnormal.
Nervous system disorders. Very common: somnolence.
Uncommon: headache1.
Respiratory, thoracic and mediastinal disorders. Uncommon: cough1, bronchitis1.
Gastrointestinal disorders. Common: gastrointestinal disorders such as diarrhoea and vomiting.
Skin and subcutaneous tissue disorders. Common: pruritus.
Uncommon: rash.
Rare: urticaria.
General disorders and administration site conditions. Very common: redness, local swelling at the injection site (≤ 50 mm), fever ≥ 38.0°C.
Common: pain2, local swelling at the injection site (> 50 mm)3.
Uncommon: injection site reactions including indurations, fatigue1, fever ≥ 39.1°C, diffuse swelling of the injected limb, sometimes involving the adjacent joint3.
Postmarketing experience. Blood and lymphatic system disorders. Thrombocytopenia4.
Immune system disorders. Allergic reactions, including anaphylactic and anaphylactoid reactions.
Nervous system disorders. Collapse or shock-like state (hypotonic hyporesponsiveness episode), convulsions (with or without fever) within 2 to 3 days of vaccination.
Respiratory, thoracic and mediastinal disorders. Apnoea [see Section 4.4 Special Warnings and Precautions for Use for apnoea in very premature infants (≤ 28 weeks of gestation)].
Skin and subcutaneous tissue disorders. Angioneurotic oedema.
General disorders and administration site conditions. Swelling of the entire injected limb3.
1 Reported only with booster vaccination.
2 Very common for booster vaccination.
3 Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. Local swelling at the injection site (> 50 mm) and diffuse swelling may be more frequent (very common and common, respectively) when the booster dose is administered between 4 and 6 years. These reactions resolve over an average of 4 days.
4 Reported with D and T vaccines.
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, when reported, are not specific but similar to adverse events 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. Infanrix DTPa vaccine induces antibodies against all vaccine components.
Clinical trials. Primary immunisation - protective efficacy studies. In a randomised, double blind, controlled clinical study conducted in Italy, the efficacy of a primary vaccination course of Infanrix against pertussis was assessed. Pertussis was defined as illness with paroxysmal cough of ≥ 21 days, and confirmation of B. pertussis infection by culture or serology. Infants were administered three vaccine doses at 2, 4, and 6 months of age, and followed for an average of 17 months. Of 4481 infants receiving 3 doses of Infanrix, 37 confirmed cases of pertussis were reported. Of 1470 infants in the control group receiving 3 doses of diphtheria and tetanus antigens only, 74 confirmed cases of pertussis were reported. Infanrix vaccine efficacy was calculated to be 83.9% with a two sided 95% confidence interval of 75.8% to 89.4%. Blood samples were collected from a 10% subset of children. Response to diphtheria and tetanus antigens (antibody titre > 0.1 IU/mL dose) was recorded in 96.6% and 99.8% respectively of this subset (> 0.01 IU/mL is considered the minimum protective level).
A prospective blinded household contact study conducted in Germany assessed the vaccine efficacy (VE) of a primary course of Infanrix against typical pertussis (defined by World Health Organization as spasmodic cough of ≥ 21 days, with confirmation of B. pertussis infection by culture or serology) up until the time of booster dosing. Of the 360 evaluable secondary contacts in households where there was an index case of typical pertussis, 173 were unvaccinated, 112 received Infanrix, and 75 received a whole cell DTP vaccine. Of the 173 unvaccinated contacts, 96 developed typical pertussis, compared with 7 of the 112 contacts vaccinated with Infanrix. The VE for Infanrix was calculated at 88.7% with a two sided 95% confidence interval of 76.6% to 94.6%. Protection did not wane until at least the time recommended for booster vaccination.
Primary immunisation - immunogenicity studies. The immunogenicity of primary vaccination schedules of Infanrix have been evaluated in over 1700 infants administered the vaccine at either 2, 4, and 6 months (n = 417) or 3, 4, and 5 months of age (n = 1302). For the 2, 4, 6 month schedule, over 99% of vaccinees displayed antibody titres ≥ 0.1 IU/mL for diphtheria and tetanus one month after the third dose. The pre-GMT and post-GMT values for the three pertussis antigens are provided in Table 1.
Infanrix booster dosing - following primary DTPw vaccination. The response to Infanrix booster doses after a primary DTPw vaccination course has been assessed in 559 children administered doses at 15-20 months (n = 400) or at 3 to 7 years of age (n = 159). Similar booster responses following the fourth at 15-20 months of age or fifth vaccine dose at 3-7 years of age, were observed for each of the vaccine antigens studied. Following the fourth vaccine dose, diphtheria and tetanus antibodies one month after vaccination were demonstrated in 94.0% and 99.3% of vaccinees respectively; compared to antibody responses of 99.4% and 98.1% respectively following the fifth vaccine dose. All vaccinees had antibody titres of ≥ 0.1 IU/mL against diphtheria and tetanus. The pre and post GMT values for the three pertussis antigens following a fourth or fifth vaccine dose are provided in Table 2 and Table 3. Overall the booster response following Infanrix was equal or superior to that obtained following DTPw booster vaccination.
5.2 Pharmacokinetic Properties
Not relevant to vaccines.
5.3 Preclinical Safety Data
Genotoxicity. No data available.
Carcinogenicity. No data available.
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 in the form of aluminium hydroxide hydrate, and suspended in isotonic sodium chloride and water for injections.
6.2 Incompatibilities
Infanrix should not be mixed with other vaccines in the same syringe, with the exception of Hiberix or Act-HIB (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
Infanrix should be stored at +2°C and +8°C. Do not freeze; discard if vaccine has been frozen. The expiry date of the vaccine is indicated on the label and packaging.
6.5 Nature and Contents of Container
Infanrix is presented as 0.5 mL of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.
The tip cap and rubber plunger stopper of the pre-filled syringe are not made with natural rubber latex.
Infanrix is supplied in packs of 1 or packs of 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
Not relevant to vaccines.
7 Medicine Schedule (Poisons Standard)
Schedule 4 - Prescription Only Medicine.
Date of First Approval
02 December 2009
Date of Revision
13 July 2023
Summary Table of Changes
Reasonable care is taken to provide accurate information at the time of creation. This information is not intended as a substitute for medical advice and should not be exclusively relied on to manage or diagnose a medical condition. The Australian Commission on Safety and Quality in Health Care disclaims all liability (including for negligence) for any loss, damage, injury or any other negative effects resulting from reliance on or use of this information. Read our full disclaimer. This website uses cookies. Read our privacy policy.