Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

585

Participants

Timeline

Start Date

April 16, 2014

Primary Completion Date

February 6, 2015

Study Completion Date

November 13, 2015

Conditions
PoliomyelitisDiphtheriaHaemophilus Influenzae Type bTetanusAcellular PertussisHepatitis B
Interventions
BIOLOGICAL

Infanrix hexa

3 doses administered intramuscularly in the right thigh.

BIOLOGICAL

Pediarix

3 doses administered intramuscularly in the right thigh

BIOLOGICAL

ActHIB

4 doses administered intramuscularly in the upper left thigh

BIOLOGICAL

Pentacel

4 doses administered intramuscularly in the right thigh

BIOLOGICAL

Engerix-B

2 or 3 doses administered intramuscularly in the upper left thigh

BIOLOGICAL

Infanrix

1 dose administered intramuscularly in the right thigh

BIOLOGICAL

Hiberix

1 dose administered intramuscularly in the left thigh

BIOLOGICAL

Prevnar13

3 doses administered intramuscularly in the lower left thigh

BIOLOGICAL

Rotarix

2 doses administered orally

Trial Locations (43)

13210

GSK Investigational Site, Syracuse

16505

GSK Investigational Site, Erie

18960

GSK Investigational Site, Sellersville

21045

GSK Investigational Site, Columbia

22902

GSK Investigational Site, Charlottesville

30062

GSK Investigational Site, Marietta

30189

GSK Investigational Site, Woodstock

32701

GSK Investigational Site, Altamonte Springs

32763

GSK Investigational Site, Orange City

37660

GSK Investigational Site, Kingsport

40202

GSK Investigational Site, Louisville

40291

GSK Investigational Site, Louisville

40356

GSK Investigational Site, Nicholasville

45414

GSK Investigational Site, Dayton

64108

GSK Investigational Site, Kansas City

66604

GSK Investigational Site, Topeka

67010

GSK Investigational Site, Augusta

67114

GSK Investigational Site, Newton

67205

GSK Investigational Site, Wichita

72703

GSK Investigational Site, Fayetteville

80922

GSK Investigational Site, Colorado Springs

83686

GSK Investigational Site, Nampa

84041

GSK Investigational Site, Layton

84088

GSK Investigational Site, West Jordan

84095

GSK Investigational Site, South Jordan

84109

GSK Investigational Site, Salt Lake City

84604

GSK Investigational Site, Provo

84651

GSK Investigational Site, Payson

84790

GSK Investigational Site, St. George

85741

GSK Investigational Site, Tucson

92804

GSK Investigational Site, Anaheim

93726

GSK Investigational Site, Fresno

94015

GSK Investigational Site, Daly City

94545

GSK Investigational Site, Hayward

94588

GSK Investigational Site, Pleasanton

94596

GSK Investigational Site, Walnut Creek

94611

GSK Investigational Site, Oakland

95051

GSK Investigational Site, Santa Clara

95119

GSK Investigational Site, San Jose

95661

GSK Investigational Site, Roseville

95815

GSK Investigational Site, Sacramento

95823

GSK Investigational Site, Sacramento

98926

GSK Investigational Site, Ellensburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02096263 - Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants | Biotech Hunter | Biotech Hunter