NCT00366899

Study Evaluating 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 Paediatric Vaccinations in Italy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 75 Days – 105 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 Italy.

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
BIOLOGICAL	7 valent pneumococcal conjugate vaccine	Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-08-21
• Last updated: 2013-02-22
• Results posted: 2013-02-22

Locations

13 sites across 1 country: Italy