Pharmacotherapeutic group: Bacterial and viral vaccines, combined. ATC code: J07CA11.
Pharmacology: Pharmacodynamics: In a phase-III clinical trial involving 6-8 week old healthy infants the combined liquid pentavalent DTwP-rHepB-Hib vaccine manufactured by Biological E. Limited has demonstrated a comparable safety and immunogenicity in comparison with a licensed, WHO prequalified vaccine marketed in India. The primary immunogenicity analysis showed seroprotection rates of 98.25%, 100%, 96.49%, 94.74% and 89.47% against Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus influenzae type b antigen components respectively.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.