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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00197015 |
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Hepatitis A |
Biological: Havrix™ Biological: VARIVAX™ Biological: M-M-RII |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-Administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 m of Age |
Enrollment: | 1474 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
HAV Group: Active Comparator |
Biological: Havrix™
2 IM injections, 6 months apart
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MMR+V→HAV Group: Active Comparator |
Biological: VARIVAX™
1 SC injection, in the right deltoid
Biological: M-M-RII
1 SC injection, in the left deltoid
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HAV+MMR+V Group: Experimental |
Biological: VARIVAX™
1 SC injection, in the right deltoid
Biological: M-M-RII
1 SC injection, in the left deltoid
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An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II and Varivax™ followed by Havrix™ one month later.
Ages Eligible for Study: | 12 Months to 13 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 208109/231 |
Study First Received: | September 13, 2005 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00197015 |
Health Authority: | United States: Food and Drug Administration |
Herpes Zoster Liver Diseases Measles Chickenpox Hepatitis, Viral, Human Picornaviridae Infections Rubella |
Hepatitis Virus Diseases Digestive System Diseases Hepatitis A Chicken pox Enterovirus Infections Mumps |
RNA Virus Infections |