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

NCT00718237 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 762

Last updated 2017-04-13

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

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

Rotateq orally administered 3 times

BIOLOGICAL

Comparator: Comparator: Placebo (unspecified)

Placebo orally administered 3 times

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00718237 on ClinicalTrials.gov