Rotavirus Efficacy and Safety Trial (REST)(V260-006)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rotavirus Infections

Treatments: Biological: Rotateq™; Biological: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090233

V260-006

2004_012

Details and patient eligibility

About

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

Enrollment: 69,274 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants

Exclusion criteria

• None Specified

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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69,274 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

RotaTeq

Treatment:

Biological: Rotateq™

2

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Comparator: Placebo