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Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

NCT00729001 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 529

Last updated 2016-09-16

No results posted yet for this study

Summary

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

Human Rotavirus Vaccine - two different formulations

Two oral doses

BIOLOGICAL

Prevnar

Three-dose intramuscular injection (US subjects only)

BIOLOGICAL

IPOL

Two-dose intramuscular injection (US subjects only)

BIOLOGICAL

Infanrix

Three-dose intramuscular injection (US subjects only)

BIOLOGICAL

OmniHIB

Three-dose intramuscular injection (US subjects only)

BIOLOGICAL

Pentacel

Three-dose intramuscular injection (Canada only)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2000-11-30
Primary Completion
2002-09-30
Completion
2002-09-30

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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 NCT00729001 on ClinicalTrials.gov