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

Phase 3CompletedNCT00718237

Merck Sharp & Dohme LLC762 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

762

Conditions

Rotavirus Gastroenteritis

Interventions

Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)BIOLOGICAL

Rotateq orally administered 3 times

Comparator: Comparator: Placebo (unspecified)BIOLOGICAL

Placebo orally administered 3 times

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age 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

Outcomes

Primary Outcomes

Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

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

Time frame: At least 14 days following the 3rd vaccination

Secondary Outcomes

Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

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.

Time frame: At least 14 days following the 3rd vaccination

Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

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.

Time frame: At least 14 days following the 3rd vaccination

Data from ClinicalTrials.gov

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