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

Phase 4

Completed

• Conditions: Polio; Tetanus; Haemophilus Infection; Pertussis; Diphtheria
• Interventions: Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)

• Registration Number: NCT00802867
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2005-06
• Study Completion: 2005-09
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Results First Submitted: 2009-09-24
• Results First Submitted QC: 2009-12-08
• Results First Posted: 2010-01-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 989

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)	Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®	0 to 3 days post-dose 5 vaccination	Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.; Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.