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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00109278 |
The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).
Condition | Intervention | Phase |
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Measles |
Biological: V205C, measles, mumps, and rubella virus vaccine live Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age |
Enrollment: | 1100 |
Study Start Date: | October 2004 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
The duration of treatment is 6 weeks.
Ages Eligible for Study: | 12 Months to 18 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: | 2005_016, V205C-010 |
Study First Received: | April 26, 2005 |
Last Updated: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00109278 |
Health Authority: | United States: Food and Drug Administration |
Prevention of Measles |
Virus Diseases Paramyxoviridae Infections Measles |
Healthy Rubella Mumps |
RNA Virus Infections Morbillivirus Infections Mononegavirales Infections |