Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine

NCT00313950 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2014-01-22

No results posted yet for this study

Summary

The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.

Conditions

Interventions

BIOLOGICAL

Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella

0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)

BIOLOGICAL

Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine

0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)

BIOLOGICAL

Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella

0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
13 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-12-31
Completion
2010-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

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 NCT00313950 on ClinicalTrials.gov