NCT00824655

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 140 Days – 392 Days
• Healthy volunteers: Accepted

Summary

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	13vPnC	13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
BIOLOGICAL	13vPnC	13vPnC will be administered by intramuscular injection at approximately 12 months of age.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-01-19
• Last updated: 2011-08-10
• Results posted: 2011-07-18

Locations

7 sites across 1 country: Sweden