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To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

NCT00363545 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1274

Last updated 2018-06-08

Study results available
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Summary

This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

Lyophilized formulation of HRV vaccine

Lyophilized formulation of HRV vaccine

BIOLOGICAL

Liquid formulation of HRV vaccine

Liquid formulation of HRV vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-09-01
Primary Completion
2007-04-12
Completion
2007-04-12

Countries

  • Panama

Study Locations

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Entities

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 NCT00363545 on ClinicalTrials.gov