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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00092430 |
The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.
Condition | Intervention | Phase |
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Measles Mumps Rubella Varicella |
Biological: V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study |
Official Title: | A Comparison of the Safety, Tolerability, and Immunogenicity of a Refrigerator-Stable Measles, Mumps, Rubella, and Varicella Combination Vaccine V221 (Refrigerated) Versus V221 (Frozen) in Healthy Children |
Ages Eligible for Study: | 12 Months to 23 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_076 |
Study First Received: | September 22, 2004 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00092430 |
Health Authority: | United States: Food and Drug Administration |
Herpes Zoster Mouth Diseases Paramyxoviridae Infections Measles Chickenpox Healthy Rubella Togaviridae Infections |
Herpesviridae Infections Virus Diseases DNA Virus Infections Chicken pox Stomatognathic Diseases Salivary Gland Diseases Mumps |
Rubivirus Infections Parotid Diseases RNA Virus Infections Morbillivirus Infections |
Parotitis Rubulavirus Infections Mononegavirales Infections |