Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

Phase 3

Completed

• Conditions: Diarrhea; Fever; Vomiting
• Interventions: Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent

• Registration Number: NCT00362648
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-08
• Study First Submitted QC: 2006-08-09
• Study First Posted: 2006-08-10
• Study Start: 2007-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-03-11
• Results First Submitted QC: 2010-04-26
• Results First Posted: 2010-05-13
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7504

Inclusion Criteria

• Age 4 weeks through 12 weeks at Dose 1
• Parent able to understand study procedures and give consent

Exclusion Criteria

• Clinical evidence of active gastrointestinal disease
• Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent	RotaTeq™

Primary Outcome Measures

Name	Time	Method
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose	At least 14 days following the third vaccination

Secondary Outcome Measures

Name	Time	Method
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]	14 days following the 3rd vaccination	Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]	14 days following the 3rd vaccination	Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)