NCT00366678

Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in 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 Routine Pediatric Vaccinations in France.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 613 (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 pediatric vaccines in France.

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
BIOLOGICAL	7-valent pneumococcal conjugate vaccine	Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
DRUG	Pentavac	The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2006-08-21
• Last updated: 2012-08-15
• Results posted: 2012-08-15

Locations

45 sites across 1 country: France