Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

Phase 3

Completed

• Conditions: Gastroenteritis; Rotavirus
• Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)

• Registration Number: NCT00718237
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Study Start: 2008-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-06-23
• Results First Submitted QC: 2010-06-23
• Results First Posted: 2010-07-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 762

Inclusion Criteria

• Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age

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Exclusion Criteria

• History Of Known Prior Rotavirus Gastroenteritis
• Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)	RotaTeq™

Primary Outcome Measures

Name	Time	Method
Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A	At least 14 days following the 3rd vaccination	Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A	At least 14 days following the 3rd vaccination	Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of \>8 and \<=16 was considered moderate, and \>16 was considered severe.
Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A	At least 14 days following the 3rd vaccination	Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of \>8 and \<=16 was considered moderate, and \>16 was considered severe.