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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00861744 |
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine
Condition | Intervention | Phase |
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Diseases Caused by Measles, Mumps, Rubella and Varicella Viruses |
Biological: M-M-R® II (Merck and Co) Biological: Varivax® Biological: GSK Biological's investigational vaccine 209762 Biological: Havrix® Biological: Prevnar® |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Immunogenicity of GlaxoSmithKline Biologicals' MMR Vaccine (209762) vs. M-M-R® II, When Co-administered With Hepatitis A, Varicella and Pneumococcal Conjugate Vaccines to Children 12-15 Months of Age |
Estimated Enrollment: | 1200 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 3: Experimental
Subjects in this group will receive GSK 209762 investigational vaccine (Lot 3)
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Biological: GSK Biological's investigational vaccine 209762
Subcutaneous injection, one dose
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Group 1: Experimental
Subjects in this group will receive GSK 209762 investigational vaccine (Lot 1)
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Biological: Varivax®
Subcutaneous injection, one dose
Biological: GSK Biological's investigational vaccine 209762
Subcutaneous injection, one dose
Biological: Havrix®
Intramuscular injection, one dose
Biological: Prevnar®
Intramuscular injection, one dose
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Group 2: Experimental
Subjects in this group will receive GSK 209762 investigational vaccine (Lot 2)
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Biological: GSK Biological's investigational vaccine 209762
Subcutaneous injection, one dose
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Group 4: Active Comparator
Subjects in this group will randomly receive one of three different commercially-available lot of M-M-R II (Merck and Co.)
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Biological: M-M-R® II (Merck and Co)
Subcutaneous injection, one dose
Biological: Varivax®
Subcutaneous injection, one dose
Biological: Havrix®
Intramuscular injection, one dose
Biological: Prevnar®
Intramuscular injection, one dose
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Ages Eligible for Study: | 12 Months to 16 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111870 |
Study First Received: | March 12, 2009 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00861744 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Measles, Mumps, Rubella, Varicella Vaccine Vaccines Combined Vaccine Children |
Humans Immunogenicity Safety |
Virus Diseases Hepatitis Herpes Zoster Paramyxoviridae Infections Measles Chickenpox |
Hepatitis A DNA Virus Infections Rubella Togaviridae Infections Mumps Herpesviridae Infections |
Herpes Zoster RNA Virus Infections Morbillivirus Infections Paramyxoviridae Infections Measles Chickenpox Rubella |
Togaviridae Infections Herpesviridae Infections Virus Diseases Rubivirus Infections DNA Virus Infections Mononegavirales Infections |