Consumer medicine information

Boostrix-IPV

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

BRAND INFORMATION

Brand name

Boostrix-IPV

Active ingredient

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

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Boostrix-IPV.

What is in this leaflet

Please read this leaflet carefully before you start using BOOSTRIX-IPV.

This leaflet answers some common questions about BOOSTRIX-IPV. 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 risks of you receiving BOOSTRIX-IPV against the expected benefits they expect it will have.

If you have any concerns about receiving BOOSTRIX-IPV, ask your doctor, nurse or pharmacist.

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

What BOOSTRIX-IPV is used for

BOOSTRIX-IPV is a vaccine used as a booster to prevent four diseases, diphtheria, tetanus, pertussis (whooping cough) and poliomyelitis (polio) 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. Poliomyelitis is an infectious disease caused by viral 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 middle 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.

Poliomyelitis (Polio)
Polio is a viral infection that can have variable effects. Often it causes only a mild illness but in some people it causes permanent injury or death. In its severest form, polio infection causes paralysis of the muscles, including those needed for breathing and walking. Polio infection can leave a person unable to breathe without the help of an iron lung machine, unable to walk without leg braces, or confined to a wheel chair. The limbs affected by the disease may be painfully deformed.

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

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

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

There is not enough information to recommend the use of this medicine for children under the age of 4 years.

Before you are given BOOSTRIX-IPV

When you must not be given it

Do not have BOOSTRIX-IPV if:

  • You or your child has had an allergic reaction to:
    - BOOSTRIX-IPV, or any ingredient contained in this vaccine. The ingredients in BOOSTRIX-IPV are listed at the end of this leaflet
    - to any other vaccine containing diphtheria, tetanus, pertussis or inactivated polio (such as Infanrix, Triple Antigen, Tripacel or Ipol vaccine)
    Some of the symptoms of an allergic reaction may include:
    - shortness of breath
    - wheezing or difficulty breathing
    - swelling of the face, lips, tongue, or other parts of the body
    - rash, itching or hives on the skin
  • 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 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 not received a complete course of diphtheria or tetanus vaccine previously.

Do not use this vaccine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you or your child should receive BOOSTRIX-IPV, talk to your doctor or nurse.

Before being given BOOSTRIX-IPV

Tell your doctor if you or your child have or have had any of the following medical problems:

  • after having BOOSTRIX-IPV or another pertussis-containing vaccine (such as Infanrix or Triple Antigen) you or your child had any problems, especially:
    - a high temperature (≥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 a severe infection with a high temperature. A minor infection such as a cold should not be problem, but talk to your doctor or nurse about this before vaccination
  • a family history of Sudden Infant Death Syndrome (SIDS)
  • a tendency to febrile convulsions (seizures/fits due to a fever or high body temperate)
  • brain disease or central nervous system (CNS) disease (ie. epilepsy etc.)
  • a bleeding problem or bruises easily
  • allergy to the antibiotics neomycin sulfate and polymyxin sulfate
  • lowered immunity due to medical treatment or a medical condition.
  • you or your child fainted with a previous injection. Fainting can occur following, or even before any needle injection.

Tell your doctor if your child is less than 4 years of age. The vaccine is only intended for use in children aged 4 years and above and in adults. The vaccine may not be as effective in infants younger than 4 years of age, because of the low diphtheria, tetanus and pertussis antigen content

Tell your doctor if you or your child has allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits of receiving BOOSTRIX-IPV during pregnancy (in particular during the 3rd trimester).

It is not known if BOOSTRIX-IPV passes into breast milk.

If you have not told your doctor about any of the above, tell him/her before you receive BOOSTRIX-IPV.

Taking other medicines

Tell your doctor, nurse or pharmacist if you or your child are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and BOOSTRIX-IPV may interfere with each other.

The following medicines may affect how well BOOSTRIX-IPV works:

  • medicines which suppress the immune system, such as high-dose corticosteroids (steroids).

Your doctor, nurse or pharmacist have more information on medicines to be careful with or avoid when given this vaccine.

Having other vaccines

Tell your doctor or nurse if you or your child has received another vaccine recently.

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

How BOOSTRIX-IPV is given

The doctor or nurse will give BOOSTRIX-IPV 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-IPV is 0.5 mL.

How it is given

BOOSTRIX-IPV will be injected in the upper arm muscle. Each dose of BOOSTRIX-IPV is for single use only. Any residual vaccine must be discarded.

The vaccine should never be given intravenously.

When it is given

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

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

Do not give your medicine to anyone else, even if they have the same condition as you.

If a dose is missed

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

If you are not sure what to do, ask your doctor, nurse or pharmacist.

While being given BOOSTRIX-IPV

Things you must do

Keep the follow up visits with the doctor or clinic. It is important the follow-up doses of BOOSTRIX-IPV are given at the correct times. This will ensure the best effect of the vaccine in protecting you or your child against diphtheria, tetanus, pertussis and poliovirus infection.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you or your child do not feel well during or after having had a dose of BOOSTRIX-IPV.

BOOSTRIX-IPV helps protect most children and adults from diphtheria, tetanus, pertussis and poliovirus infection, but it may have unwanted side effects in a few people. 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 having a permanent injury from the natural infections.

Most unwanted effects with BOOSTRIX-IPV are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

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):

  • sleepiness
  • swelling, pain, redness at the injection site

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

  • loss of appetite
  • irritability
  • headache
  • fever (more than 37.5°C)
  • bleeding at the injection site.

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

  • swollen glands in the neck, armpit or groin
  • sleeping problems
  • apathy
  • dry throat
  • diarrhoea, vomiting, nausea
  • stomach pain or discomfort
  • tiredness.

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 at the injection site
  • tiredness.

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

  • fever (more than 37.5°C)
  • bruising at the injection site
  • nausea, vomiting, diarrhoea and/or abdominal pain.

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

  • oral herpes
  • swollen glands in the neck, armpit or groin
  • decreased appetite
  • tingling or numbness of the hands or feet
  • sleepiness
  • dizziness
  • asthma
  • itching
  • joint pain, muscle pain
  • fever (more than 39°C)
  • 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, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • fits (with or without fever)
  • hives
  • hard lump at the injection site
  • extensive swelling of the vaccinated limb
  • unusual weakness.

Additionally, the following side effects have been reported during clinical studies or routine use of Boostrix (GlaxoSmithKline Biological’s booster vaccine against diphtheria, tetanus and pertussis):

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

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

  • nausea, vomiting, diarrhoea and/or abdominal pain.

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
  • skin rash
  • pain
  • hard lump at the injection site.

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):

  • generally feeling unwell

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

  • nausea
  • 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
  • fainting
  • cough
  • diarrhoea, vomiting
  • excessive sweating
  • skin rash
  • joint or muscle stiffness
  • flu-like symptoms, such as fever, sore throat, runny nose, cough and chills.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • sudden sign of allergy such as rash, itching or hives on the skin, swelling of limbs, face, eyes, lips, mouth, throat or other part of the body
  • shortness of breath, breathing or swallowing difficulties
  • unusual tiredness or weakness that is sudden and severe.

These are signs of an allergic reaction. As with all vaccines given by injection there is a very small risk of such reactions. Allergy to BOOSTRIX-IPV is rare. Any such severe reactions will usually occur within the first few hours of vaccination.

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

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

How to store BOOSTRIX-IPV

Storage

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

  • Keep BOOSTRIX-IPV 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
  • BOOSTRIX-IPV should be used immediately after opening
  • Keep BOOSTRIX-IPV in the original pack until it is time for it to be given.
  • Protect from light.

Disposal

Ask your pharmacist what to do with any BOOSTRIX-IPV that has expired or has not been used.

Product description

What it looks like

BOOSTRIX-IPV comes in a prefilled syringe. It is a white, slightly milky liquid.

Ingredients

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

The vaccine cannot cause these diseases.

Each 0.5 mL dose contains:

  • 2 IU of diphtheria toxoid
  • 20 IU of tetanus toxoid
  • 8 micrograms of pertussis toxoid, 8 micrograms of filamentous haemagglutinin and 2.5 micrograms of pertactin
  • 40 D-antigen units of poliovirus Type 1, 8 D-antigen units of poliovirus Type 2 and 32 D-antigen units of poliovirus Type 3.

The inactive ingredients in the vaccine are: aluminium hydroxide hydrate and aluminium phosphate as adjuvants, sodium chloride (salt), Medium 199 (which contains phenylalanine), water for injections, and traces of formaldehyde, polysorbate 80, neomycin sulfate and polymyxin sulfate.

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.

Supplier

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

Date of Preparation: 20 August 2019

BOOSTRIX-IPV 0.5mL injection syringe (AUST R 96137)

Version 5.0

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

© 2019 GSK group of companies or its licensor.

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Boostrix-IPV

Active ingredient

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

Schedule

S4

 

1 Name of Medicine

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

6.7 Physicochemical Properties

Chemical structure.

Not relevant to vaccines.

CAS number.

Not relevant to vaccines.

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.

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 (> twofold 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.

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.

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.
The NHMRC currently recommends only 4 doses of polio vaccines in childhood, and that polio boosters for adults are not necessary unless they are at special risk, such as: travellers to areas or countries where poliomyelitis is epidemic or endemic; healthcare workers in possible contact with poliomyelitis cases.
For those exposed to continuing risk of infection a single booster dose is desirable every 10 years.
The NHMRC currently recommends boosting against diphtheria, tetanus and pertussis using an adolescent/ adult formulation dTpa at 15 to 17 years of age. Before the eighth birthday, DTP containing vaccines should be given, as they contain a larger dose of diphtheria toxoid. After the eighth birthday, smaller doses of toxoid (adult/ adolescent formulation dTpa or dT containing vaccines) should be given.
A booster dose of dTpa is also recommended:
Before planning pregnancy, or for both parents as soon as possible after delivery of an infant;
For adults working with young children;
For any adult expressing an interest in receiving a booster dose of dTpa, provided that a primary course of DTP vaccine has been given in the past.
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.

4.3 Contraindications

Boostrix-IPV should not be administered 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 child 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 regard 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. 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.
(Category B1)
The use of Boostrix-IPV may be considered during the third trimester of pregnancy (See Section 4.1 Therapeutic Indications).
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 (dTpa component of Boostrix-IPV) was administered to pregnant women during the third trimester (793 pregnancy outcomes) as well as data from post-marketing surveillance where pregnant women were exposed to Boostrix-IPV or to Boostrix has not detected an elevated frequency or unusual patterns of adverse events.
As with other inactivated vaccines, it is not expected that the polio antigens contained in Boostrix-IPV would harm the foetus.
Human data from prospective clinical studies on the use of Boostrix-IPV 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-IPV during pregnancy. The clinical relevance of this observation is unknown.
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.
Boostrix-IPV should be used during pregnancy when the possible advantages outweigh the possible risks for the foetus. (See Section 4.1 Therapeutic Indications). When protection against tetanus is sought, consideration should be given to tetanus or combined diphtheria-tetanus vaccines.
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.

4.8 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.
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.

4.2 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. Discard 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.

Administration.

Boostrix-IPV is administered by deep intramuscular injection preferably in the deltoid region of the arm. 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.

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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

S4.

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 formaldehyde, polysorbate 80, neomycin sulfate and polymyxin 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.

6.5 Nature and Contents of Container

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

Summary Table of Changes