Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose

Phase 3

Completed

• Conditions: Hepatitis A
• Interventions: Biological: Hepatitis A vaccine (HAVRIX 720); Biological: Hepatitis A vaccine AVAXIM 80U

• Registration Number: NCT00483470
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-07
• Primary Completion: 2008-05
• Study Completion: 2008-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Hepatitis A vaccine (HAVRIX 720)	-
1	Hepatitis A vaccine AVAXIM 80U	-

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine	1 month post-vaccination