The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-14 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
QUADRUPLE
Enrollment
3,994
Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
Occurrence of severe RV GE caused by the circulating wild-type RV strains during the each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of G1 serotype during each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of non-G1 serotypes during each efficacy follow-up period.
Occurrence of hospitalization due to RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.
Occurrence of any medical attention (medical provider contact, advice, visit; emergency room contact or visit or hospitalization) for RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the period starting from Dose 1 of the study vaccine until Visit 5.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period in subjects who completed the two-dose vaccination course before the RV epidemic season.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period in subjects who were vaccinated during the RV epidemic season.
Immune response to HRV vaccine at Visit 1 and Visit 3.
Immune response to all antigens contained in each of the different childhood vaccines at Visit 3 and Visit 4 or Visit 6 (if applicable):
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GSK Investigational Site
Brno, Czechia
GSK Investigational Site
Havlíčkův Brod, Czechia
GSK Investigational Site
Hradec Králové, Czechia
GSK Investigational Site
Humpolec, Czechia
GSK Investigational Site
Jindřichův Hradec, Czechia
GSK Investigational Site
Náchod, Czechia
GSK Investigational Site
Ostrava, Czechia
GSK Investigational Site
Pardubice, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
...and 91 more locations
In a subset of subjects (N=1800), occurrence of each type of solicited symptom within the 8-day solicited follow-up period (Day 0 to Day 7) after each dose of HRV/placebo.
For all subjects, occurrence of unsolicited symptoms within 31 days (Day 0 to Day 30) after each dose of HRV/placebo and SAEs throughout the entire study period.