MedTrace Logo

Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants

NCT01171963 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3340

Last updated 2018-08-06

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

GSK Biologicals' liquid human rotavirus vaccine 444563

Oral administration

BIOLOGICAL

Placebo

Oral administration

BIOLOGICAL

Infanrix™

Intramuscular administration

BIOLOGICAL

Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)

Oral administration

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
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-29
Primary Completion
2012-05-12
Completion
2012-05-12

Countries

  • China

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 NCT01171963 on ClinicalTrials.gov