This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

1,280

Participants

Timeline

Start Date

September 14, 2017

Primary Completion Date

October 9, 2018

Study Completion Date

March 1, 2019

Conditions
Rotavirus InfectionRotavirus Vaccines
Interventions
BIOLOGICAL

Rotarix

Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.

BIOLOGICAL

Pediarix

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

BIOLOGICAL

Hiberix

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

BIOLOGICAL

Prevenar 13

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Trial Locations (47)

10468

GSK Investigational Site, The Bronx

13202

GSK Investigational Site, Syracuse

16148

GSK Investigational Site, Hermitage

21702

GSK Investigational Site, Frederick

22902

GSK Investigational Site, Charlottesville

27609

GSK Investigational Site, Raleigh

28607

GSK Investigational Site, Boone

29407

GSK Investigational Site, Charleston

32701

GSK Investigational Site, Altamonte Springs

33142

GSK Investigational Site, Miami

33435

GSK Investigational Site, Boynton Beach

33617

GSK Investigational Site, Tampa

35205

GSK Investigational Site, Birmingham

37660

GSK Investigational Site, Kingsport

40004

GSK Investigational Site, Bardstown

40202

GSK Investigational Site, Louisville

43123

GSK Investigational Site, Grove City

44121

GSK Investigational Site, Cleveland

45406

GSK Investigational Site, Dayton

45414

GSK Investigational Site, Dayton

45419

GSK Investigational Site, Dayton

48025

GSK Investigational Site, Bingham Farms

54449

GSK Investigational Site, Marshfield

68504

GSK Investigational Site, Lincoln

68505

GSK Investigational Site, Lincoln

68522

GSK Investigational Site, Lincoln

72401

GSK Investigational Site, Jonesboro

72703

GSK Investigational Site, Fayetteville

76107

GSK Investigational Site, Fort Worth

77375

GSK Investigational Site, Tomball

77555

GSK Investigational Site, Galveston

80922

GSK Investigational Site, Colorado Springs

83686

GSK Investigational Site, Nampa

84037

GSK Investigational Site, Kaysville

84041

GSK Investigational Site, Layton

84057

GSK Investigational Site, Orem

84067

GSK Investigational Site, Roy

84075

GSK Investigational Site, Syracuse

84095

GSK Investigational Site, South Jordan

84107

GSK Investigational Site, Murray

84604

GSK Investigational Site, Provo

91790

GSK Investigational Site, West Covina

94015

GSK Investigational Site, Daly City

94596

GSK Investigational Site, Walnut Creek

94611

GSK Investigational Site, Oakland

02721

GSK Investigational Site, Fall River

29406-9170

GSK Investigational Site, North Charleston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03207750 - This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine | Biotech Hunter | Biotech Hunter