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Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

NCT00757770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 854

Last updated 2016-09-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

Rotarix

Two oral doses.

BIOLOGICAL

Placebo

Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.

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
2003-08-31
Primary Completion
2004-01-31
Completion
2004-01-31

Countries

  • Colombia
  • Mexico
  • Peru

Study Locations

More Related Trials

Entities

Drugs
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 NCT00757770 on ClinicalTrials.gov