Dose Confirmation Efficacy Study (V260-007)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-06-30

Brief Summary

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This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

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Detailed Description

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The duration of treatment is 10 months.

Conditions

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Rotavirus Infections

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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RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent)

administered 28 to 70 days apart.

Group Type EXPERIMENTAL

RotaTeq™, rotavirus vaccine, live, oral, pentavalent

Intervention Type BIOLOGICAL

Three doses of RotaTeq™ administered 28 to 70 days apart.

Placebo matching RotaTeq™

Placebo matching RotaTeq™ administered 28 to 70 days apart.

Group Type PLACEBO_COMPARATOR

Comparator: Placebo matching RotaTeq™

Intervention Type BIOLOGICAL

Placebo matching RotaTeq™ administered 28 to 70 days apart.

Interventions

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RotaTeq™, rotavirus vaccine, live, oral, pentavalent

Three doses of RotaTeq™ administered 28 to 70 days apart.

Intervention Type BIOLOGICAL

Comparator: Placebo matching RotaTeq™

Placebo matching RotaTeq™ administered 28 to 70 days apart.

Intervention Type BIOLOGICAL

Other Intervention Names

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V260

Eligibility Criteria

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Inclusion Criteria

* Healthy infants

Exclusion Criteria

* History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
* Known or suspected problems with immune system
* Fever at time of immunization
* Prior administration of a rotavirus vaccine
* History of known prior rotavirus disease
* Chronic diarrhea, or failure to thrive

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes