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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Vomiting Diarrhea Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

RotaTeq™

Group Type EXPERIMENTAL

RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent

Intervention Type BIOLOGICAL

2.0 mL oral dose of RotaTeq™. 14 week treatment period

2

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type BIOLOGICAL

Arm 2: Placebo. 14 week treatment period

Interventions

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RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent

2.0 mL oral dose of RotaTeq™. 14 week treatment period

Intervention Type BIOLOGICAL

Comparator: Placebo

Arm 2: Placebo. 14 week treatment period

Intervention Type BIOLOGICAL

Other Intervention Names

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RotaTeq™ V260

Eligibility Criteria

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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

Minimum Eligible Age

4 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes