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Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) in Toddlers, Children and Adolescents

NCT02011763 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2015-10-01

No results posted yet for this study

Summary

The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to confirm the good safety profile of the vaccine.

Primary objective:

* To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered 6 months apart, in subjects aged 12 months to 15 years.

Conditions

  • Hepatitis A
  • Hepatitis A Virus

Interventions

BIOLOGICAL

Avaxim 80U Pediatric: Inactivated Hepatitis A Virus

0.5 mL, Intramuscular (2 injection 6 months apart)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-09-30
Completion
2015-08-31

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 NCT02011763 on ClinicalTrials.gov