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
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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