Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

PHASE3CompletedINTERVENTIONAL
Enrollment

1,351

Participants

Timeline

Start Date

July 19, 2019

Primary Completion Date

November 30, 2020

Study Completion Date

November 30, 2020

Conditions
Infections, Rotavirus
Interventions
BIOLOGICAL

PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine

2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.

BIOLOGICAL

Lyophilized formulation of GSK's oral live attenuated HRV vaccine

2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.

Trial Locations (37)

100

GSK Investigational Site, Taipei

104

GSK Investigational Site, Taipei

500

GSK Investigational Site, Changhua

13210

GSK Investigational Site, Syracuse

21702

GSK Investigational Site, Frederick

22902

GSK Investigational Site, Charlottesville

26040

GSK Investigational Site, Eskişehir

35235

GSK Investigational Site, Birmingham

35340

GSK Investigational Site, Izmir

38030

GSK Investigational Site, Kayseri

40291

GSK Investigational Site, Louisville

45014

GSK Investigational Site, Fairfield

45245

GSK Investigational Site, Cincinnati

48025

GSK Investigational Site, Bingham Farms

68504

GSK Investigational Site, Lincoln

68516

GSK Investigational Site, Lincoln

68522

GSK Investigational Site, Lincoln

80922

GSK Investigational Site, Colorado Springs

83301

GSK Investigational Site, Kaohsiung City

84020

GSK Investigational Site, Draper

84057

GSK Investigational Site, Orem

84095

GSK Investigational Site, South Jordan

84107

GSK Investigational Site, Murray

97330

GSK Investigational Site, Corvallis

02721-1735

GSK Investigational Site, Fall River

07108

GSK Investigational Site, East Orange

T3B 6A8

GSK Investigational Site, Calgary

V3S 2N6

GSK Investigational Site, Surrey

B3K 6R8

GSK Investigational Site, Halifax

B2N 1L2

GSK Investigational Site, Truro

L6T 0G1

GSK Investigational Site, Brampton

N5W 6A2

GSK Investigational Site, London

N7T 4X3

GSK Investigational Site, Sarnia

H3T 1C5

GSK Investigational Site, Montreal

G1V 4G2

GSK Investigational Site, Québec

Unknown

GSK Investigational Site, Pokfulam

GSK Investigational Site, Shatin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03954743 - Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks | Biotech Hunter | Biotech Hunter