Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rotavirus; Gastroenteritis

Treatments: Biological: Comparator: Comparator: Placebo (unspecified); Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718237

V260-029

2008_014

Details and patient eligibility

About

The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.

Enrollment: 762 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age

Exclusion criteria

• History Of Known Prior Rotavirus Gastroenteritis
• Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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762 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

RotaTeq™

Treatment:

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)

2

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Comparator: Comparator: Placebo (unspecified)