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

NCT00483470 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2014-01-22

No results posted yet for this study

Summary

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

Conditions

  • Hepatitis A

Interventions

BIOLOGICAL

Hepatitis A vaccine AVAXIM 80U

0.5 mL, Intramuscular

BIOLOGICAL

Hepatitis A vaccine (HAVRIX 720)

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-05-31
Completion
2008-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483470 on ClinicalTrials.gov