INFORMATION FOR HEALTH PROFESSIONALS
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INFANRIX™-IPV contains diphtheria toxoid, tetanus toxoid, and three purified pertussis antigens (pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN/69 kiloDalton outer membrane protein)( adsorbed on aluminium salts. It also contains three types of inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3: Saukett strain).
The diphtheria and tetanus toxoids obtained from cultures of Corynebacterium diphtheriae and Clostridium tetani are inactivated and purified. The acellular pertussis vaccine components (PT, FHA and pertactin) are prepared by growing phase I Bordetella pertussis from which the PT, FHA and pertactin are extracted and purified. FHA and pertactin are treated with formaldehyde, PT is treated with glutaraldehyde and formaldehyde, and irreversibly inactivated.
The three polioviruses are cultivated on a continuous VERO cell line, purified and inactivated with formaldehyde.
INFANRIX™-IPV meets the World Health Organisation requirements for the manufacture of biological substances, of diphtheria, tetanus, pertussis and combined vaccines, and of inactivated poliomyelitis vaccines.
A 0.5 ml dose of vaccine contains not less than 25 Lf ( ≈ min. 30 IU) of adsorbed diphtheria toxoid, not less than 10 Lf ( ≈ min. 40 IU) of adsorbed tetanus toxoid, 25 µg of PT, 25 mcg of FHA, 8 mcg of pertactin, 40 D antigen units of type 1 (Mahoney), 8 D antigen units of type 2 (MEF-1) and 32 D antigen units of type 3 (Saukett) of the polio virus.
Suspension, Injection.
INFANRIX™-IPV is indicated for active primary immunisation against diphtheria, tetanus, pertussis, and poliomyelitis.
INFANRIX-IPV is also indicated as a booster dose for children who have previously been immunised with DTP and polio antigens.
Not applicable
The primary vaccination schedule consists of three doses in the first year of life. An interval of at least 1 month should be respected between doses.
In order to maintain protection a booster dose is recommended. An interval of at least 6 months after completion of primary vaccination schedule should be adhered to. Local immunisation schedule recommendations should be followed for primary and booster doses.
Data on the use of the vaccine as a booster has been obtained for children up to 13 years of age.
INFANRIX™-IPV is for deep intramuscular injection. For infants, the preferred site is the anterolateral aspect of the thigh; in older children, vaccine should be administered in the deltoid.
It is preferable that each subsequent dose is given at alternate sites.
INFANRIX™-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.
INFANRIX™-IPV 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 diphtheria, tetanus, pertussis, or inactivated poliomyelitis vaccines.
INFANRIX™-IPV is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
As with other vaccines, the administration of INFANRIX™-IPV should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication.
It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
If any of the following events occur in temporal relation to receipt of DTP-containing vaccine, 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 the events are not associated with permanent sequelae. According to available clinical data, the risk benefit ratio of acellular pertussis vaccine is better than the risk benefit ratio of whole cell pertussis vaccine. The following events were previously considered contra-indications for DTPw and can now be considered precautions :
In children with progressive neurological isorders, 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, a family history of convulsions, a family history of Sudden Infant Death Syndrome (SIDS) or a family history of an adverse event following DTP and/or IPV vaccination do not constitute contra-indications.
Human Immunodeficiency Virus (HIV) infection is not considered as a contra-indication.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Infanrix™-IPV contains traces of neomycin and polymyxin. The vaccine should be used with caution in patients with known hypersensitivity to one of these antibiotics.
As with all diphtheria, tetanus, and pertussis vaccines, the vaccine should be given deep intramuscularly.
INFANRIX™-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.
INFANRIX™-IPV should under no circumstances be administered intravenously.
It is current practice in paediatric vaccination to co-administer different vaccines during the same session, where injectable vaccines should always be given at different injection sites.
Infanrix™-IPV can be administered concomitantly with hepatitis B vaccine, and/or Haemophilus influenzae vaccine, the injections being applied at different injection sites. Routine simultaneous administration of Hib vaccine and hepatitis B vaccine may be given to children who are at the recommended age to receive these vaccines.
Although data on the concomitant administration of Infanrix™-IPV and measles, mumps and rubella combined vaccine and varicella vaccine are not available, it is generally accepted that they may be given at the same time if separate injection sites are used.
As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response may not be achieved.
Adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Not applicable.
Adverse reactions associated with vaccination have been evaluated in 11 clinical trials. Adverse event data were actively collected using diary cards and by questioning the parents at clinic visits. Events solicited, and frequently reported, were local reactions (pain/tenderness, redness and swelling) and systemic symptoms (fever, unusual crying, restlessness, irritability, sleeping more or less than usual, malaise, loss of appetite, nausea, vomiting, diarrhoea, headache [headache reported following booster doses only in 6-13 year olds]). The incidence of these symptoms was variable across the trials. As has been observed for other licensed DTPa vaccines, an increase in local reactogenicity and fever >39.5°C was reported after booster vaccination.
The following events were also commonly reported in the clinical trials in temporal association with vaccination. It should be noted that causality has not necessarily been established for these events.
Gastrointestinal system: tooth ache
Respiratory system: rhinitis. pharyngitis
Application site: injection site mass
Resistance mechanism: upper respiratory tract infection, otitis media
Vision: conjunctivitis
Psychiatric: somnolence, insomnia
Gastrointestinal system: tooth ache
Respiratory system: rhinitis, bronchitis, pharyngitis
Application site: injection site mass
Resistance mechanism: upper respiratory tract infection, otitis media
Skin and appendages: puritis
Respiratory system: coughing, rhinitis, pharyngitis
Body as a whole: asthenia
Resistance mechanism: otitis media
Studies have been conducted to evaluate the incidence of local swelling reactions after booster administration. The frequency of these reactions was as follows:
Very common (≥1/10): local swelling at the injection site (≤50 mm)
Common (≥1/100, <1/10): local swelling at the injection site (>50 mm)*
Uncommon (≥1/100, <1/10): diffuse swelling of the injected limb, sometimes
involving the adjacent joint.*
*Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparision with children primed with whole cell vaccines. Local swelling at the injection site (>50 mm) and diffuse swelling may be more frequent (ver common and common, respectively) when they booster dose is administered between 4 and 6 years. These reactions resolve over an average of 4 days.
Very rare allergic reactions, including anaphylactoid reactions, have been reported following vaccination with DTPa containing vaccines.
Extremely rare cases of collapse or shock-like state (hypotonic-hyporesponsiveness episode) and convulsions within 2 to 3 days of vaccination have been reported for infants receiving pertussis containing vaccines. All the subjects recovered totally without sequelae.
Swelling of the entire injected limb has been reported.
Not applicable.
One month after a primary vaccination course more than 99% of infants vaccinated with INFANRIX™-IPV had antibody titers of ≥ 0.1 IU/ml to both tetanus and diphtheria.
Following administration of a booster dose of INFANRIX™-IPV, more than 99.5% of children had antibody titers of ≥ 0.1 IU/ml for both antigens.
One month after the 3-dose primary vaccination course with INFANRIX™-IPV 100% of infants were seropositive for the three pertussis components (PT, FHA, pertactin), and the overall response rates for each of the three individual pertussis antigens were ≥ 94%.
A booster response was seen in the vast majority of vaccinees against the pertussis antigens; lower response rates were seen in studies where the pre-vaccination levels of antibodies were high. All subjects were seropositive one month after this dose.
As the immune response to pertussis antigens following INFANRIX™-IPV administration is equivalent to that of Infanrix™, it can be assumed that the protective efficacy of the two vaccines will also be equivalent.
The clinical protection of the DTPa component, against WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) was demonstrated in :
- 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%.
- a NIH (National Institute of Health - USA) sponsored efficacy study performed in Italy (2,4,6 months schedule). The vaccine efficacy was found to be 84%. In a follow-up study of the same cohort, the efficacy was confirmed for up to 4 years of age.
One month after the primary vaccination, the overall seropositivity for each of the three serotypes (type 1, 2 and 3) was ≥ 99.5%.
Following administration of a booster dose of INFANRIX-IPV, 100% of children were seropositive for the three serotypes.
In all booster trials, vaccination induced a marked increase in antibody levels with respect to pre-booster values.
Evaluation of pharmacokinetic properties is not required for vaccines.
Sodium chloride, potassium chloride, disodium phosphate, monopotassium phosphate, 2-phenoxyethanol, aluminum salts, polysorbate 80, glycine, formaldehyde, M 199 (as stabilizer), neomycin sulfate, polymyxin sulfate, water for injections.
INFANRIX™-IPV should not be mixed with other vaccines in the same syringe.
The expiry date of the vaccine is indicated on the label and packaging.
The shelf life of the vaccine is 36 months.
INFANRIX™-IPV should be stored at +2°C to +8°C.
The vaccine should not be frozen. Discard if it has been frozen.
INFANRIX™-IPV is a turbid white suspension presented in a prefilled syringe. Upon storage, a white deposit and clear supernatant can be observed.
The prefilled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.
The vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
Since a white sediment may form during storage, INFANRIX™-IPV should be well shaken.
Prefilled syringes in packs of 1 or 10.
Prescription Medicine
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert & Customs Street
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
Telephone: (09) 367 2900
Facsimile: (09) 367 2506
19 June 2007