NCT00772928

Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,167 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 42 Days – 89 Days
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™ Primary Objective - Stage I: To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®). Primary Objective - Stage II: To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

Detailed description

This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®. Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.

Conditions

• Diphtheria
• Tetanus
• Haemophilus Infection
• Pertussis
• Polio

Interventions

Type	Name	Description
BIOLOGICAL	Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®	0.5 mL, Intramuscular
BIOLOGICAL	Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®	0.5 mL, Intramuscular

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-05-01
• Completion: 2006-11-01
• First posted: 2008-10-15
• Last updated: 2012-02-01
• Results posted: 2010-02-12

Locations

23 sites across 1 country: United States