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Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00092456 |
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
Condition | Intervention | Phase |
---|---|---|
Rotavirus Infections |
Biological: rotavirus vaccine, live, oral, pentavalent |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants |
Enrollment: | 784 |
Study Start Date: | May 2003 |
Study Completion Date: | September 2004 |
Ages Eligible for Study: | 6 Weeks to 12 Weeks |
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_078, V260-009 |
Study First Received: | September 22, 2004 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00092456 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Rotavirus Infections Healthy |
RNA Virus Infections Reoviridae Infections Infection |