Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

GlaxoSmithKline6,360 enrolled

Overview

The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

6,360

Conditions

Infections, Rotavirus

Interventions

2-dose oral live attenuated G1P[8] human rotavirus vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Healthy infants 6 -12 weeks old at Dose 1 with written informed consent. Exclusion criteria: * Allergic reaction to vaccine components; * clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; * immunocompromised.

Locations (17)

GSK Investigational Site

Colonia Caroya, Córdoba Province, Argentina

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

Outcomes

Primary Outcomes

Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.

Secondary Outcomes

Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines

Data from ClinicalTrials.gov

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