Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
69274 participants
INTERVENTIONAL
2001-01-31
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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1
RotaTeq
Rotateq™
3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
2
Placebo
Comparator: Placebo
3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
Interventions
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Rotateq™
3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
Comparator: Placebo
3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Weeks
12 Weeks
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB, Shinefield HR, Christie CD, Ylitalo S, Itzler RF, Coia ML, Onorato MT, Adeyi BA, Marshall GS, Gothefors L, Campens D, Karvonen A, Watt JP, O'Brien KL, DiNubile MJ, Clark HF, Boslego JW, Offit PA, Heaton PM; Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006 Jan 5;354(1):23-33. doi: 10.1056/NEJMoa052664.
Itzler R, Koch G, Matson DO, Gothefors L, Van Damme P, Dinubile MJ, Heaton PM. Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5). BMC Pediatr. 2010 Jun 11;10:42. doi: 10.1186/1471-2431-10-42.
Other Identifiers
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2004_012
Identifier Type: -
Identifier Source: secondary_id
V260-006
Identifier Type: -
Identifier Source: org_study_id
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