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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Infections, Rotavirus

Treatments

Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00139347
444563/024

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

17

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems