A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants

Phase 3

Completed

• Conditions: Haemophilus Influenzae Type B; Pertussis; Diphtheria; Tetanus
• Interventions: Biological: DTaP//PRP-T Combined Vaccine; Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine

• Registration Number: NCT01062477
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China

Primary Objectives:

* To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination.

* To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination.

Secondary Objectives:

* To describe the safety after administration of the study vaccines.

* To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.

Detailed Description

Participants will receive a primary vaccination consisting of three doses of ACTACEL at either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at 18-20 months of age and will be followed up for one month after the last dose of study vaccine.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Primary Completion: 2011-09
• Status Verified: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-12
• Last Update Posted: 2011-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1056

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 2	DTaP//PRP-T Combined Vaccine	Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.
Study Group 1	DTaP//PRP-T Combined Vaccine	Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.
Study Group 3	DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine	Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.

Primary Outcome Measures

Name	Time	Method
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.	One month post-vaccination

Secondary Outcome Measures

Name	Time	Method
Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine.	0-7 days post-vaccination and entire study duration