NCT00090233

Rotavirus Efficacy and Safety Trial (REST)(V260-006)

Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69,274 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

Conditions

• Rotavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	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.

Timeline

• Start date: 2001-01-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2004-08-27
• Last updated: 2015-10-05
• Results posted: 2011-05-05