This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis...
Date First Received: August 25, 2004
Last Updated: May 17, 2006
Verified by: Merck, September 2005
Clinical Trial Phase: Phase 3 | Start Date: December 2000
Overall Status: Completed
Estimated Enrollment: 60000
Brief Summary
Official Title: “Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants”
Condition Keyword(s):
This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Biological: V260, rotavirus vaccine, live, oral, pentavalent / Duration of Treatment: 3 years
Outcome Measures for this Clinical Trial
Primary Measures
- Occurance of clinical rotavirus disease caused by serotypes G1, G2, G3 and G4 that occurs 14 days following 3rd dose; serum neutralizing antibodies (SNA) against rotavirus; risk of intussusception within 42 days following any dose
Criteria for Participation in this Clinical Trial
- Healthy infants
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Weeks
Maximum Age for this Clinical Trial: 12 Weeks
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Related Publications
Citations Reporting Results
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00090233
Study ID Number: 2004_012
ClinicalTrials.gov Identifier: NCT00090233
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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