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Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants

NCT00429481 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2464

Last updated 2016-09-16

No results posted yet for this study

Summary

To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.

Conditions

Interventions

BIOLOGICAL

Rotarix

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Weeks
Max Age
17 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2003-04-30
Completion
2003-04-30

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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 NCT00429481 on ClinicalTrials.gov