NCT00254917

Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Weeks – 19 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Diphtheria
• Tetanus
• Polio
• Pertussis
• Haemophilus Influenzae Type B

Interventions

Type	Name	Description
BIOLOGICAL	Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine	0.5 mL, IM
BIOLOGICAL	Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine	0.5 mL, IM

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2005-11-17
• Last updated: 2012-04-16

Locations

1 site across 1 country: Philippines