Infanrix®-IPV

Infanrix®-IPV

DTaP-IPV

  • Overview
  • In Depth
  • Ingredients
Medsafe Datasheet

Infanrix®-IPV is used for primary and booster vaccination of infants and children up to their 7th birthday to protect against diphtheria, tetanus, pertussis and poliomyelitis.

Vaccine Schedule

Recommended and offered free on the New Zealand Immunisation schedule to all children at 4 years of age.

Who should get the vaccine

All children up to their 7th birthday.

Children with a personal history of a hypotonic hyporesponsive episode (HHE) CAN have the vaccine.

Children with a family history of Sudden lnfant Death Syndrome (SIDS) or convulsions following a diphtheria, tetanus and pertussis vaccination CAN have the vaccine.

 

Who should not get the vaccine

Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine; a previous dose of diphtheria, tetanus, pertussis, or polio vaccine or a component of the vaccine.

Administration of Infanrix®-IPV should be postponed in individuals suffering from a fever over 38°C.

The presence of a minor infection is not a reason to delay immunisation.

How effective is the vaccine

Diphtheria
The vaccine gives 87–98% protection from the disease but the disease is less severe in the 2–13% who have been immunised but who are not fully protected. The duration of protection is expected to be around 10 years.

Tetanus
Almost 100% of infants have protection after three doses of vaccine. The duration of protection is expected to last at least 20 years.

Pertussis (whooping cough)
A study of children under two years of age showed that 84% have protection against the disease. The duration of protection starts to wane after about 6 years.

Polio
Over 90% of children are protected. The duration of protection is expected to last at least 18 years.

How safe is the vaccine?

For all vaccines, similar to most medications, an extremely rare allergic reaction called ‘anaphylaxis’ can occur. Anaphylaxis after immunisation occurs about 1-3 times in every one million vaccine doses. All vaccinators will have training and equipment to deal with this situation in the unlikely event of it occurring.

No other serious responses to the vaccine have been identified. Large reactions where the injection has been given, sometimes involving the entire upper part of the limb, have been reported after the fourth and fifth doses of tetanus, diphtheria and pertussis vaccines. They resolve without treatment. Tetanus, diphtheria and pertussis vaccines can be given in the future. These reactions do not predict a similar reaction occurring after future doses.

What if my child misses a dose?

Children can catch up missed doses of this vaccine anytime before their 7th birthday. Children aged 5 years and over do not routinely require immunisation against Haemophilus influenza type b. This vaccine can be used to catch up missed infant doses of Infanrix®-hexa.

Recommendations

Infanrix®-IPV is not administered to children after their 7th birthday or adults. Alternative vaccines are available for these age groups.

Possible vaccine side effects
Common side effectsUncommon side effectsRare/very rare side effects
Soreness/pain, redness and/or swelling around the injection site.
Fever over 38°C.
Decreased appetite, vomiting and/or diarrhoea.
Irritability, restlessness.
Unusual crying.
Fatigue.
Swelling involving the entire thigh or upper arm occurs in 2–3 percent of children after administration of the fourth and fifth doses of acellular pertussis vaccine. It resolves spontaneously without long term consequences.
Extensive limb swelling after the fourth dose does not predict an increased risk of a similar reaction following the fifth dose of pertussis vaccine.
Anaphylaxis.
Urticaria.
Idiopathic thrombocytopenic purpura.
Convulsion within 2 days of immunisation.
Inflammation of the nerve in the arm causing muscle weakness and pain (brachial neuritis) occurs within four weeks of immunisation, 1- 2 times per 200,000 doses. It may occur in either the injected or non-injected arm. Recovery is spontaneous and usually without long term consequences.

References

GlaxoSmithKline NZ Ltd. Infanrix-IPV data sheet [Home page on the internet]. Wellington: Medsafe; 2009 [cited 2011, May 16]. Available from: http://www.medsafe.govt.nz/profs/Datasheet/i/InfanrixIPVinj.pdf.
Medical Advisory Committee of Haemophilia Foundation of New Zealand. National guidelines management of haemophilia - treatment protocols. Christchurch: Haemophilia Foundation of New Zealand; 2005.
Ministry of Health. Childhood immunisation. Wellington: Ministry of Health; 2008.
Other Vaccine Brands

Infanrix®-IPV

Dosage and Administration

Infanrix®-IPV is administered by deep intramuscular injection. The deltoid muscle is the preferred site for older children.

Infanrix®-IPV should be administered to children with thrombocytopenia or bleeding disorders, e.g. haemophilia, in accordance with their haematologist's instructions. The vaccine may be given subcutaneously if the person's haematologist has advised against intramuscular injection of immunisations. Firm pressure should be applied to the injection site (without rubbing) for at least ten minutes following either intramuscular or subcutaneous injection.

Infanrix®-IPV can be given to a child with a history of a hypotonic hyporesponsive episode (HHE) within 48 hours of a previous pertussis vaccination or convulsions  with or without fever within  3 days of a previous pertussis vaccination.

Infanrix®-IPV can be given to a child with a family history of Sudden lnfant Death Syndrome (SIDS) or convulsions following a diphtheria, tetanus and pertussis vaccination.

Infanrix®-IPV can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.

Store between +2°C to +8°C. The expiry date of the vaccine is the last day of the month in the year indicated on the packaging.

 

Efficacy/Effectiveness

After administration of a booster dose of Infanrix®-IPV more than 99.5% of children demonstrated protective antibody titre of > 0.1 lU/mls against tetanus and diphtheria. All vaccine recipients demonstrated a marked increase in protective antibody levels, with respect to pre-booster levels, against all three sertotypes of polio covered by the vaccine.

After administration of a booster dose of Infanrix®™-IPV a booster response was also seen in the majority of vaccinees against the pertussis antigens; lower response rates were seen where the pre-vaccination levels of antibodies were high. All vaccine recipients were seropositive one month after the booster dose however studies have not yet established a correlation between serology results and protection against pertussis. Collection of data from secondary contacts in households where there was an index case with pertussis the protective efficacy of the vaccine was 84-88.7%.

Catch-Up

Infanrix®-IPV is not administered to children after their 7th birthday or adults. Refer to the catch up section of the current Immunisation Handbook for age appropriate catch up schedules.

Contraindications

A severe allergy (anaphylaxis) to a previous dose of this vaccine; a previous dose of diphtheria, tetanus, pertussis, or polio vaccine or a component of the vaccine.

Administration of Infanrix®™-IPV should be postponed in individuals suffering from acute severe febrile illness (fever over 38°C). The presence of a minor infection is not a contraindication.

Where a child has an evolving neurological disorder (eg, uncontrolled epilepsy or deteriorating neurological state) there is the potential for confusion about the role of vaccination while clinically unstable. The risks and benefits of withholding vaccination until the clinical situation has stabilised should be considered on an individual basis after careful consideration of the risks and benefits.

History of a hypotonic hyporesponsive episode (HHE) within 48 hours of a previous pertussis vaccination or convulsions  with or without fever within  3 days of a previous pertussis vaccination ARE NOT contraindications for administration of Infanrix®™-IPV.

A family history of Sudden lnfant Death Syndrome (SIDS) or convulsions following a diphtheria, tetanus and pertussis vaccination ARE NOT contraindications for administration of Infanrix®™-IPV.

Vaccine type: Subunit and inactivated

Ingredients Quantity/dose (0.5ml) Function
Active substances    
Diphtheria toxoid, adsorbed Not less than 30 international units (IU) or 25 Lime flocculation units (Lf U) Antigen
Tetanus toxoid, adsorbed Not less than 40 IU or 10 Lf U Antigen
Pertussis toxoid, adsorbed 25 micrograms (μg) Antigen
Filamentous haemagglutinin, adsorbed 25 μg Antigen
Pertactin, (69 kiloDalton outer membrane protein) 8 μg  Antigen
Inactivated Polio Virus Type 1  40 D-antigen unit (DU) Antigen
Inactivated Polio Virus Type 2  8 DU Antigen
Inactivated Polio Virus Type 3 32 DU Antigen
     
Adjuvants    
Aluminium hydroxide Less than 0.625 mg by assay Adjuvant
     
Excipients    
Culture medium Residual Grow Clostridium tetani (tetanus), Corynebacterium diphtheriae (diphtheria), Bordetella pertussis (pertussis); stabilise polio viruses
Glutaraldahyde Residual Inactivate pertussis toxins
Formaldehyde Less than or equal to 100 μg Antimicrobial; stabiliser; inactivate tetanus, diphtheria toxins; inactivate polio viruses
Amino acids, bovine derived materials, glutamate, phosphate, sucrose, vitamins Residual Components of culture medium
Recombinant human albumin Residual Stabiliser in culture media
Glycine Residual Protein stabiliser
2-phenoxyethanol Residual Preservative
Neomycin, polymyxin Trace Antibacterial
Potassium chloride Residual Buffer; component of growth media
Disodium phosphate, monopotassium phosphate Residual Buffer
Sodium chloride 4.5 mg Buffer
Water for injection   Solvent