Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

4,003

Participants

Timeline

Start Date

June 18, 2010

Primary Completion Date

November 18, 2011

Study Completion Date

July 17, 2013

Conditions
Haemophilus Influenzae Type b
Interventions
BIOLOGICAL

GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)

Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.

BIOLOGICAL

ActHIB™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination

BIOLOGICAL

Pentacel™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination

BIOLOGICAL

Pediarix™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

BIOLOGICAL

Prevnar 13™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

BIOLOGICAL

Rotarix™

Two oral doses in primary epoch at 2 and 4 months of age

BIOLOGICAL

Engerix™-B

Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection

BIOLOGICAL

Infanrix™

One dose in the booster epoch at 15-18 months of age as intramuscular injection

Trial Locations (63)

11501

GSK Investigational Site, Mineola

13210

GSK Investigational Site, Syracuse

13502

GSK Investigational Site, Utica

16125

GSK Investigational Site, Greenville

16148

GSK Investigational Site, Hermitage

16505

GSK Investigational Site, Erie

29406

GSK Investigational Site, Charleston

30062

GSK Investigational Site, Marietta

30189

GSK Investigational Site, Woodstock

32763

GSK Investigational Site, Orange City

36305

GSK Investigational Site, Dothan

40004

GSK Investigational Site, Bardstown

40291

GSK Investigational Site, Louisville

44121

GSK Investigational Site, Cleveland

44718

GSK Investigational Site, Canton

45229

GSK Investigational Site, Cincinnati

45406

GSK Investigational Site, Dayton

49127

GSK Investigational Site, Stevensville

53792

GSK Investigational Site, Madison

54449

GSK Investigational Site, Marshfield

55108

GSK Investigational Site, Saint Paul

58103

GSK Investigational Site, Fargo

68131

GSK Investigational Site, Omaha

72019

GSK Investigational Site, Benton

72205

GSK Investigational Site, Little Rock

72401

GSK Investigational Site, Jonesboro

72703

GSK Investigational Site, Fayetteville

74107

GSK Investigational Site, Tulsa

76107

GSK Investigational Site, Fort Worth

77055

GSK Investigational Site, Houston

77479

GSK Investigational Site, Sugar Land

79124

GSK Investigational Site, Amarillo

80304

GSK Investigational Site, Boulder

80922

GSK Investigational Site, Colorado Springs

83686

GSK Investigational Site, Nampa

84010

GSK Investigational Site, Bountiful

84041

GSK Investigational Site, Layton

84067

GSK Investigational Site, Roy

84075

GSK Investigational Site, Syracuse

84095

GSK Investigational Site, South Jordan

84109

GSK Investigational Site, Salt Lake City

91790

GSK Investigational Site, West Covina

92647

GSK Investigational Site, Huntington Beach

92708

GSK Investigational Site, Fountain Valley

92804

GSK Investigational Site, Anaheim

93726

GSK Investigational Site, Fresno

94015

GSK Investigational Site, Daly City

94063

GSK Investigational Site, Redwood City

94509

GSK Investigational Site, Antioch

94538

GSK Investigational Site, Fremont

94545

GSK Investigational Site, Hayward

94589

GSK Investigational Site, Vallejo

94596

GSK Investigational Site, Walnut Creek

94612

GSK Investigational Site, Oakland

95051

GSK Investigational Site, Santa Clara

95119

GSK Investigational Site, San Jose

95403

GSK Investigational Site, Santa Rosa

95661

GSK Investigational Site, Roseville

95815

GSK Investigational Site, Sacramento

95823

GSK Investigational Site, Sacramento

96797

GSK Investigational Site, Waipio

96819

GSK Investigational Site, Honolulu

02721

GSK Investigational Site, Fall River

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01000974 - Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants | Biotech Hunter | Biotech Hunter