NCT00452790

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 708 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 42 Days – 72 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	1 dose at 6, 10, 14 weeks and 12 months of age
BIOLOGICAL	7 valent pneumococcal conjugate vaccine	1 dose at 6, 10, 14 weeks and 12 months of age

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-10-01
• Completion: 2010-02-01
• First posted: 2007-03-27
• Last updated: 2011-03-24
• Results posted: 2010-11-15

Locations

12 sites across 1 country: India