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Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

NCT00969228 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 684

Last updated 2020-01-18

Study results available
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Summary

The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.

Conditions

  • Infections, Rotavirus
  • Rotavirus Vaccines

Interventions

BIOLOGICAL

Rotarix ™

Two oral doses

BIOLOGICAL

Placebo

Two oral doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-25
Primary Completion
2010-07-23
Completion
2010-07-23

Countries

  • South Korea

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 NCT00969228 on ClinicalTrials.gov