NCT01026038

Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.

Conditions

• 13-valent Pneumococcal Vaccine
• Immunization
• Safety
• Antibody Response

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-12-04
• Last updated: 2012-02-08
• Results posted: 2012-02-08

Locations

25 sites across 1 country: France