INFANRIX ™ New Product 1997, 1998 (last year) Smithkline Beecham
Diphtheria and Tetanus Toxoids—Acellular Pertussis Vaccine
Active Immunizing Agent
Pharmacology: Infanrix contains pertussis toxoid, filamentous hemaglutinin and pertactin, antigens which are considered to play an important role in protection against pertussis disease.
Immune Response of Infanrix Primary Immunization: One month after a 3-dose primary vaccination course with 1 718 subjects in the first 6 months of life more than 99% of infants vaccinated with Infanrix had antibody litres of more than 0.1 IU/mL to both diphtheria and tetanus.
In an NIH sponsored Italian study 1 month after a 3-dose primary vaccination course during the first 6 months of life, 93.7% and 99.4% of infants, vaccinated with Infanrix had antibody titres of more than 0.01 IU/mL to both diphtheria and tetanus respectively.
In these clinical studies, the vaccine response to these pertussis antigens was more than 95%.
Immune Response of Infanrix Booster Immunization: Following administration of an Infanrix booster in the second year of life (13 to 24 months) all Infanrix-primed infants had antibody titres 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.
Protective Efficacy of Infanrix: Based on data collected from secondary contacts in households where there was an index case with typical pertussis, the protective efficacy of Infanrix was calculated to be 88.7%, with a 2-sided 95% confidence interval of 76.6 to 94.6%.
In an NIH sponsored efficacy study performed in Italy (2, 4 and 6 months schedule), the vaccine efficacy was found to be 84%.
Indications: For active primary immunization against diphtheria, tetanus and pertussis in children of age 2 months and older, and as a booster in children up to and including 6 years of age, who have previously been immunized with 3 or 4 doses of either diphtheria, tetanus and acellular pertussis (DTPa) vaccine or diphtheria, tetanus and whole-cell pertussis (DTPw) vaccine.
Contraindications: 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 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, DTPw or DT vaccines.
A history of febrile convulsions and a family history of convulsive fits do not constitute contraindications.
HIV infection is not considered as a contraindication.
As for all diphtheria, tetanus and pertussis vaccines, each injection should be given deep i.m. and preferably at different injection sites.
Infanrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an i.m. administration to these subjects.
DTPa vaccine should not be administered to persons 7 years of age or older because of the dangers of reactions to the diphtheria toxoid and pertussis antigens.
Elective immunization of individuals over 6 months should be deferred during an outbreak of poliomyelitis. Infanrix should under no circumstances be administered intravascularly.
Precautions: General: As with any other vaccine, Infanrix may not protect 100% of individuals receiving the vaccine. As with other injectable vaccines, appropriate medication (e.g., epinephrine 1:1 000) should be readily available for immediate use in case of anaphylaxis or anaphylactoid reactions following administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after immunization.
If any of the following events occur in temporal relation to receipt of DTPa or DTPw vaccines, 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 contraindications for DTPw and can now be considered general precautions: 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.
Patients with Special Diseases and Conditions: In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immunologic response may not be achieved.
Drug Interactions: Infanrix can be administered in any temporal relationship with other childhood vaccines.
Different injectable vaccines should always be administered at different injection sites.
Special Warnings and Special Precautions for Use: It is good clinical practice that immunization should be preceded by a review of the medical history (especially with regard to previous immunization and possible occurrence of undesirable events) and a clinical examination.
Table 1 – Infanrix
Solicited Symptoms (Based on the Results of the Pivotal Comparative Studies)
| 
