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

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

Official Title
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A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan

Conditions
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Rotavirus, Gastroenteritis

Intervention / Treatment
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* Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
* Biological: Comparator: Comparator: Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RotaTeq™ | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)<br>* Rotateq orally administered 3 times<br>* Other names: V260;|
| Placebo Comparator: 2<br>Placebo | Biological: Comparator: Comparator: Placebo (unspecified)<br>* Placebo orally administered 3 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At least 14 days following the 3rd vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At least 14 days following the 3rd vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenteritis, Rotavirus