INFORMATION FOR HEALTH PROFESSIONALS
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INFANRIX is presented as a turbid white suspension in a glass prefilled syringe. Upon storage a white deposit and clear supernatant is observed.
INFANRIX contains diphtheria toxoid, tetanus toxoid and three purified pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and 69 kilodalton (kDa) outer membrane protein (pertactin)] adsorbed onto aluminium salts.
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 pertactin) are prepared by growing phase I Bordetella pertussis from which the PT and FHA and pertactin are extracted, purified and treated with formaldehyde; PT is irreversibly detoxified.
The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine components are adsorbed on aluminium salts. The final vaccine is formulated in saline and contains 2-phenoxyethanol as preservative.
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.
A 0.5mL dose of the vaccine contains not less than 30 International Units (IU) of diphtheria toxoid, 40 IU of tetanus toxoid, 25 μg of PT, 25 μg of FHA and 8 μg of pertactin.
INFANRIX (DTPa) is indicated for active primary immunisation against diptheria, tetanus and pertussis.
INFANRIX is indicated as fourth and/or fifth dose for children from 15 months of age up to and including 6 years of age who have previously been immunised with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.
INFANRIX is administered by intramuscular injection. THE VACCINE SHOULD NEVER BE ADMINISTERED INTRAVENOUSLY.
The recommended dose (0.5 mL) of the vaccine must be administered.
The primary immunisation course consists of 3 doses with boosters during the second and sixth year of life.
Each dose consists of a 0.5mL ready to use sterile suspension. Before use of INFANRIX, the vaccine should be well shaken to obtain a homogenous turbid suspension. Discard the vaccine if it appears otherwise.
All parenteral drug and vaccine products should be inspected visually for any particulate matter or discolouration prior to administration.
INFANRIX should be injected intramuscularly in the lateral aspect of the thigh or the deltoid region of the arm.
INFANRIX should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous administration of INFANRIX, diphtheria and tetanus vaccine and DTPw.
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.
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 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.
If any of the following events occur in temporal relation to receipt of DTPa or DTPw, the decision to give subsequent 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 outweigh possible risks, particularly since these events are not associated with permanent sequelae.
The following events were previously considered contra-indications for DTPw and can now be considered general precautions :
A history of febrile convulsions and a family history of convulsive fits do not constitute contraindications.
HIV infection is not considered as a contraindication. However in patients with immunodeficiency or in patients receiving immunosuppressive therapy, an adequate immunologic response may not be achieved.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after immunisation.
As for all diphtheria, tetanus and pertussis vaccines, the vaccine should be given deep intramuscularly and preferably at alternate injection sites.
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.
INFANRIX should under no circumstances be administered intravenously.
INFANRIX can be administered in any temporal relationship with other childhood vaccines.
Different injectable vaccines should always be administered at different injection sites.
INFANRIX must not be mixed with other vaccines.
As INFANRIX is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Not applicable.
In controlled clinical studies, signs and symptoms were actively monitored and recorded on diary cards in all vaccinees following the administration of each dose of the vaccine.
The following table, based on the results of comparative studies summarises
the local solicited symptoms reported within 48 hours of vaccination as a
percentage of doses administered.
| Local solicited symptoms | Primary immunisation | Booster | ||||
|---|---|---|---|---|---|---|
| Infanrix (1275 doses) | DTPw (455 doses) | Infanrix after Infanrix primary (269 doses) |
DTPw after DTPw primary (92 doses) |
Infanrix after DTPw primary (273 doses) |
DTPw after DTPw primary (91 doses) |
|
| pain | 2.5 | 19.1 | 15.6 | 55.4 | 15.8 | 59.3 |
| redness (> 2 cm) | 0.1 | 1.1 | 4.5 | 3.3 | 2.2 | 5.5 |
| swelling (> 2 cm) | 0 | 1.3 | 3.0 | 7.6 | 1.5 | 5.5 |
General solicited symptoms which were reported in the same comparative studies
and within the same timeframe are summarised in the following table.
| General solicited symptoms (%) | Primary immunisation | Booster | ||||
|---|---|---|---|---|---|---|
| Infanrix | DTPw | Infanrix after Infanrix primary | DTPw after DTPw primary | Infanrix after DTPw primary | DTPw after DTPw primary | |
| fever > 38°C (rectal) | 9.9 | 42.2 | 26.8 | 64.1 | 29.3 | 63.7 |
| fever > 39.5°C (rectal) | 0.2 | 1.3 | 0.4 | 4.3 | 0.7 | 4.4 |
| unusal crying | 5.2 | 11.9 | 8.6 | 14.7 | 2.6 | 11.0 |
| vomiting | 3.0 | 4.4 | 3.3 | 7.6 | 2.6 | 2.2 |
| diarrhoea | 5.9 | 6.8 | 11.2 | 13.0 | 8.1 | 16.5 |
| eating and drinking less than usual | 4.2 | 20.7 | 7.1 | 43.5 | 12.5 | 29.7 |
| sleeping more than usual / drowsiness | 9.3 | 13.6 | 10.4 | 31.5 | 10.3 | 14.3 |
| sleeping less than usual / restlessness | 9.3 | 16.7 | 12.3 | 32.6 | 7.7 | 16.5 |
Additional safety data are available from other studies, which evaluate the
primary immunisation course and the booster dose administration. These studies,
which include non-comparative studies, confirmed the safety profile of DTPa
which is summarised above. Redness and swelling of more than 10 cm have been
reported after the booster dose and these resolved spontaneously. As with other
vaccines such as DT and DTP, swelling of the entire thigh has occasionally been
observed.
The following unsolicited symptoms have been reported for
Extremely rare cases of collapse or shock-like state (hypotonic-hyporesponsiveness episode) and convulsions within 2 to 3 days of vaccination have been reported. All the subjects recovered totally and spontaneously without sequelae.
Very rare allergic reactions, including anaphylactoid reactions, have been reported.
Not applicable.
One month after a three-dose primary vaccination course in the first 6 months of life more than 99% of infants vaccinated with INFANRIX had antibody titers of more than 0.1 IU/ml to both diphtheria and tetanus.
The vaccine contains PT, FHA and pertactin, antigens which are considered to play an important role in protection against pertussis disease. In clinical studies, the vaccine response to these pertussis antigens was more than 95%.
Following administration of an INFANRIX booster in the second year of life (13-24 months) all INFANRIX-primed infants had antibody titers of more than 0.1 IU/ml to both diphtheria and tetanus.
The booster response to the pertussis antigens was seen in more than 96% of these children.
The protective efficacy of INFANRIX against WHO-defined typical pertussis (21 days of paroxysmal cough with laboratory confirmation) was demonstrated in :
Evaluation of pharmacokinetic properties is not required for vaccines.
Appropriate safety tests have been performed.
INFANRIX should be stored between +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. The shelf life of INFANRIX is 36 months from the date of manufacture at a temperature of +2°C to +8°C.
Prescription Medicine
Prefilled syringes: 0.5mL in packs of 1.
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert & Customs Street
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
ph (09) 367 2900
fax (09) 367 2506
23 October 2002
Ref: MDS Version 6 (Date of approval 23/03/00)