NCT00259337

Immunogenicity and Safety of Pentaxim™ in an Indian Population

Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 42 Days – 56 Days
• Healthy volunteers: Accepted

Summary

The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life. Safety: This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).

Conditions

• Diphtheria
• Tetanus
• Polio
• Pertussis
• Haemophilus Infections

Interventions

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

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-04-01
• Completion: 2008-12-01
• First posted: 2005-11-29
• Last updated: 2012-04-16

Locations

1 site across 1 country: India