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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00258154 |
The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.
Condition | Intervention |
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Rotavirus Disease |
Biological: V260, rotavirus vaccine, live, oral, pentavalent / Duration of Treatment 3-6 months Drug: Comparator: INFANRIX (tm) hexa/Duration of Treatment 3-6 months |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Safety and Immunogenicity of Concomitant Use of V260 and INFANRIX(tm) Hexa in Healthy Infants |
Enrollment: | 522 |
Study Start Date: | February 2006 |
Study Completion Date: | June 2007 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
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: | 2005_046, V260-010 |
Study First Received: | November 15, 2005 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00258154 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Virus Diseases Rotavirus Infections Healthy |
RNA Virus Infections Reoviridae Infections |