Dose Confirmation Efficacy Study (V260-007)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rotavirus Infections

Treatments: Biological: Comparator: Placebo matching RotaTeq™; Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092443

2004_077

V260-007

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.

Full description

The duration of treatment is 10 months.

Enrollment: 1,312 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,312 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart.

Treatment:

Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent

Placebo matching RotaTeq™

Placebo Comparator group

Description:

Placebo matching RotaTeq™ administered 28 to 70 days apart.

Treatment:

Biological: Comparator: Placebo matching RotaTeq™