NCT00474539

Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 42 Days – 98 Days
• Healthy volunteers: Accepted

Summary

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

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	1 dose at 2,4,6 and 15 months of age
BIOLOGICAL	7-valent pneumococcal conjugate vaccine	1 dose at 2,4,6 and 15 months of age

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-05-17
• Last updated: 2013-03-05
• Results posted: 2013-03-05

Locations

27 sites across 1 country: Spain