V260 Registration Study (V260-013)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rotavirus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00166517

2005_071

V260-013

Details and patient eligibility

About

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Enrollment: 178 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At first study vaccination, age 6 weeks through exactly 12 weeks

Exclusion criteria

• History of congenital abdominal disorders, intussusception, or abdominal surgery
• History of known prior rotavirus disease
• Ongoing chronic diarrhea or failure to thrive
• Clinical evidence of active gastrointestinal illness

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

RotaTeq

Treatment:

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

2

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Comparator: Placebo