NCT00258895

Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

Safety and Immunogenicity of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL® or Pentacel®

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 649 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. Observational Objectives: 1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates. 3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.

Conditions

• Diphtheria
• Tetanus
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	DAPTACEL®: DTaP	0.5 mL, Intramuscular
BIOLOGICAL	DAPTACEL®: DTaP	0.5 mL, Intramuscular

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-12-01
• Completion: 2007-04-01
• First posted: 2005-11-28
• Last updated: 2016-04-14
• Results posted: 2009-09-28

Locations

22 sites across 1 country: United States