NCT00689351

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

Phase 2, 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 Korea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (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 vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.

Conditions

• Pneumococcal Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
BIOLOGICAL	7-valent pneumococcal conjugate vaccine	7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-06-03
• Last updated: 2011-06-28
• Results posted: 2011-01-11

Locations

6 sites across 1 country: South Korea