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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Fever; Vomiting; Diarrhea

Treatments: Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362648

2006_027

V260-015

Details and patient eligibility

About

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

Enrollment: 7,504 patients

Sex: All

Ages: 4 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7,504 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

RotaTeq™

Treatment:

Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent

2

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Comparator: Placebo