drugset / Trial / NCT00259337

Immunogenicity and Safety of Pentaxim™ in an Indian Population

NCT00259337

Phase 3 Completed 226 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelPrevention

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™).

Timeline

Start
2006-02
Primary completion
2008-04
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject PENTAXIM™ Vaccine 0.5 ml Intramuscular