MedTrace Logo

Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

NCT00362648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7504

Last updated 2017-04-13

Study results available
· View outcomes & findings →

Summary

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

Conditions

Interventions

BIOLOGICAL

RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent

2.0 mL oral dose of RotaTeq™. 14 week treatment period

BIOLOGICAL

Comparator: Placebo

Arm 2: Placebo. 14 week treatment period

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-03-31
Completion
2009-03-31

More Related Trials

Entities

Diseases
Companies

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 NCT00362648 on ClinicalTrials.gov