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Dose Confirmation Efficacy Study (V260-007)

NCT00092443 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1312

Last updated 2015-09-14

Study results available
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Summary

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

Conditions

  • Rotavirus Infections

Interventions

BIOLOGICAL

RotaTeq™, rotavirus vaccine, live, oral, pentavalent

Three doses of RotaTeq™ administered 28 to 70 days apart.

BIOLOGICAL

Comparator: Placebo matching RotaTeq™

Placebo matching RotaTeq™ administered 28 to 70 days apart.

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
2002-09-30
Primary Completion
2004-06-30
Completion
2004-06-30

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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 NCT00092443 on ClinicalTrials.gov