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.

NCT00259337 Phase 3 COMPLETED

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™).

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	226
Start date	2006-02
Completion	2008-12

Conditions

• Diphtheria
• Tetanus
• Polio
• Pertussis
• Haemophilus Infections

Interventions

• Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine

Primary outcomes

• To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine — 19 months

Countries

India