Tetanus Clinical Trial
The present clinical study will assess the immunogenicity and reactogenicity of the
subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine
(PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age
schedule followed by a booster vaccination during the second year of life with the aim to
cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus,
pertussis, poliomyelitis and Hib vaccines.
WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14
weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.
To assess the safety of Pentaxim.
Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one
of the two study groups as follows:
Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and
the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.
Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B
vaccines at 6, 10 and 14 weeks of age.
All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19
months of age.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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