Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

PHASE3CompletedINTERVENTIONAL
Enrollment

1,612

Participants

Timeline

Start Date

October 27, 2016

Primary Completion Date

June 27, 2018

Study Completion Date

November 26, 2018

Conditions
Infections, RotavirusRotavirus Vaccines
Interventions
BIOLOGICAL

HRV PCV-free liquid vaccine

Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

BIOLOGICAL

Rotarix

Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Trial Locations (66)

100

GSK Investigational Site, Taipei

104

GSK Investigational Site, Taipei

300

GSK Investigational Site, Hsinchu

333

GSK Investigational Site, Taoyuan District

404

GSK Investigational Site, Taichung

407

GSK Investigational Site, Taichung

12004

GSK Investigational Site, Castellon

12530

GSK Investigational Site, Castellon

16506

GSK Investigational Site, Erie

20520

GSK Investigational Site, Turku

21431

GSK Investigational Site, Incheon

26426

GSK Investigational Site, Gangwon-do

28050

GSK Investigational Site, Madrid

28100

GSK Investigational Site, Pori

29004

GSK Investigational Site, Málaga

29200

GSK Investigational Site, Antequera/Málaga

29520

GSK Investigational Site, Cheraw

29600

GSK Investigational Site, Marbella

33100

GSK Investigational Site, Tampere

35235

GSK Investigational Site, Birmingham

41013

GSK Investigational Site, Seville

44121

GSK Investigational Site, Cleveland

46020

GSK Investigational Site, Valencia

46023

GSK Investigational Site, Valencia

46200

GSK Investigational Site, Valencia

47574

GSK Investigational Site, Goch

49565

GSK Investigational Site, Bramsche

54449

GSK Investigational Site, Marshfield

60100

GSK Investigational Site, Seinäjoki

64108

GSK Investigational Site, Kansas City

66604

GSK Investigational Site, Topeka

67100

GSK Investigational Site, Kokkola

67114

GSK Investigational Site, Newton

67227

GSK Investigational Site, Frankenthal

68161

GSK Investigational Site, Mannheim

83471

GSK Investigational Site, Schönau am Königssee

83686

GSK Investigational Site, Nampa

84041

GSK Investigational Site, Layton

84057

GSK Investigational Site, Orem

84075

GSK Investigational Site, Syracuse

84107

GSK Investigational Site, Murray

84604

GSK Investigational Site, Provo

90220

GSK Investigational Site, Oulu

90723

GSK Investigational Site, Paramount

92804

GSK Investigational Site, Anaheim

95119

GSK Investigational Site, San Jose

95815

GSK Investigational Site, Sacramento

97941

GSK Investigational Site, Tauberbischofsheim

442723

GSK Investigational Site, Gyeonggido

29456-9170

GSK Investigational Site, North Charleston

Unknown

GSK Investigational Site, San José

GSK Investigational Site, San José

02230

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

274-0063

GSK Investigational Site, Chiba

299-4503

GSK Investigational Site, Chiba

350-0001

GSK Investigational Site, Saitama

360-0846

GSK Investigational Site, Saitama

146-0095

GSK Investigational Site, Tokyo

167-0052

GSK Investigational Site, Tokyo

190-0002

GSK Investigational Site, Tokyo

01450

GSK Investigational Site, Seoul

02447

GSK Investigational Site, Seoul

04619

GSK Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02914184 - Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks | Biotech Hunter | Biotech Hunter