NCT00802867

Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 989 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

Objectives: * To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. * To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

Detailed description

This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Polio
• Haemophilus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)	0.5 mL, Intramuscular

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-06-01
• Completion: 2005-09-01
• First posted: 2008-12-05
• Last updated: 2016-04-14
• Results posted: 2010-01-12

Locations

19 sites across 1 country: United States