Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

4,441

Participants

Timeline

Start Date

February 22, 2006

Primary Completion Date

August 27, 2007

Study Completion Date

February 26, 2008

Conditions
Haemophilus Influenzae Type bNeisseria Meningitidis
Interventions
BIOLOGICAL

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine

3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

BIOLOGICAL

ActHIB

3-dose intramuscular injection at 2, 4 and 6 months of age.

BIOLOGICAL

PedvaxHIB

1 booster dose by intramuscular injection at 12 to 15 months of age.

BIOLOGICAL

Pediarix

3-dose intramuscular injection at 2, 4 and 6 months of age.

BIOLOGICAL

Prevnar

3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

BIOLOGICAL

M-M-R II

1 booster dose by subcutaneous injection at 12 to 15 months of age.

BIOLOGICAL

Varivax

1 booster dose by subcutaneous injection at 12 to 15 months of age

Trial Locations (93)

2031

GSK Investigational Site, Randwick

3053

GSK Investigational Site, Carlton

4029

GSK Investigational Site, Herston

4101

GSK Investigational Site, South Brisbane

10467

GSK Investigational Site, The Bronx

11794

GSK Investigational Site, Stony Brook

13210

GSK Investigational Site, Syracuse

13413

GSK Investigational Site, New Hartford

14618

GSK Investigational Site, Rochester

14850

GSK Investigational Site, Ithaca

15010

GSK Investigational Site, Beaver Falls

15212

GSK Investigational Site, Pittsburgh

15213

GSK Investigational Site, Pittsburgh

15236

GSK Investigational Site, Pittsburgh

15241

GSK Investigational Site, Pittsburgh

16125

GSK Investigational Site, Greenville

16501

GSK Investigational Site, Erie

18960

GSK Investigational Site, Sellersville

19114

GSK Investigational Site, Philadelphia

21201

GSK Investigational Site, Baltimore

23111

GSK Investigational Site, Mechanicsville

23510

GSK Investigational Site, Norfolk

27609

GSK Investigational Site, Raleigh

27705

GSK Investigational Site, Durham

27710

GSK Investigational Site, Durham

28779

GSK Investigational Site, Sylva

29072

GSK Investigational Site, Lexington

29406

GSK Investigational Site, Charleston

32931

GSK Investigational Site, Cocoa Beach

32955

GSK Investigational Site, Rockledge

33024

GSK Investigational Site, Pembroke Pines

35216

GSK Investigational Site, Birmingham

35235

GSK Investigational Site, Birmingham

40004

GSK Investigational Site, Bardstown

40272

GSK Investigational Site, Louisville

40503

GSK Investigational Site, Lexington

43205

GSK Investigational Site, Columbus

44121

GSK Investigational Site, Cleveland

GSK Investigational Site, South Euclid

44512

GSK Investigational Site, Boardman

44718

GSK Investigational Site, Canton

45424

GSK Investigational Site, Huber Heights

49008

GSK Investigational Site, Kalamazoo

49024

GSK Investigational Site, Portage

49127

GSK Investigational Site, Stevensville

50266

GSK Investigational Site, Des Moines

50309

GSK Investigational Site, Des Moines

54601

GSK Investigational Site, La Crosse

55108

GSK Investigational Site, Saint Paul

56401

GSK Investigational Site, Brainerd

66160

GSK Investigational Site, Kansas City

67005

GSK Investigational Site, Arkansas City

68131

GSK Investigational Site, Omaha

71111

GSK Investigational Site, Bossier City

72011

GSK Investigational Site, Bryant

72202

GSK Investigational Site, Little Rock

72205

GSK Investigational Site, Little Rock

72703

GSK Investigational Site, Fayetteville

74127

GSK Investigational Site, Tulsa

76107

GSK Investigational Site, Fort Worth

76508

GSK Investigational Site, Temple

78205

GSK Investigational Site, San Antonio

79124

GSK Investigational Site, Amarillo

80501

GSK Investigational Site, Longmont

84041

GSK Investigational Site, Layton

84062

GSK Investigational Site, Pleasant Grove

84095

GSK Investigational Site, South Jordan

84790

GSK Investigational Site, St. George

85003

GSK Investigational Site, Phoenix

89025

GSK Investigational Site, North Las Vegas

90274

GSK Investigational Site, Rolling Hills Estates

90706

GSK Investigational Site, East Artesia

90723

GSK Investigational Site, Paramount

91790

GSK Investigational Site, West Covina

92037

GSK Investigational Site, La Jolla

92708

GSK Investigational Site, Fountain Valley

93710

GSK Investigational Site, Fresno

93720

GSK Investigational Site, Fresno

93726

GSK Investigational Site, Fresno

94609

GSK Investigational Site, Oakland

95817

GSK Investigational Site, Sacramento

97030

GSK Investigational Site, Gresham

98664

GSK Investigational Site, Vancouver

332901

GSK Investigational Site, Melbourne

06360

GSK Investigational Site, Norwich

208 463 3126

GSK Investigational Site, Nampa

02118

GSK Investigational Site, Boston

02724

GSK Investigational Site, Fall River

02130

GSK Investigational Site, Jamaica Plain

17033-0850

GSK Investigational Site, Hershey

02903

GSK Investigational Site, Providence

77555-0188

GSK Investigational Site, Galveston

06720

GSK Investigational Site, Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY