Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

1,106

Participants

Timeline

Start Date

January 24, 2007

Primary Completion Date

March 7, 2008

Study Completion Date

May 14, 2012

Conditions
Infections, PapillomavirusPapillomavirus Vaccines
Interventions
BIOLOGICAL

GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM)

Three doses administered intramuscularly at months 0, 1 and 6

BIOLOGICAL

Gardasil ® (Merck & Co. Inc)

Three doses administered intramuscularly at months 0, 2 and 6

BIOLOGICAL

Placebo

One dose administered intramuscularly at month 1 to maintain blinding

BIOLOGICAL

Placebo

One dose administered intramuscularly at month 2 to maintain blinding

Trial Locations (40)

10029

GSK Investigational Site, New York

10461

GSK Investigational Site, The Bronx

15106

GSK Investigational Site, Carnegie

15241

GSK Investigational Site, Upper Saint Clair

16507

GSK Investigational Site, Erie

16508

GSK Investigational Site, Erie

17601

GSK Investigational Site, Lancaster

19107

GSK Investigational Site, Philadelphia

27514

GSK Investigational Site, Chapel Hill

30342

GSK Investigational Site, Atlanta

33134

GSK Investigational Site, Coral Gables

33136

GSK Investigational Site, Miami

33437

GSK Investigational Site, Boynton Beach

40004

GSK Investigational Site, Bardstown

44094

GSK Investigational Site, Willoughby Hills

44122

GSK Investigational Site, Cleveland

45249

GSK Investigational Site, Cincinnati

49127

GSK Investigational Site, Stevensville

55108

GSK Investigational Site, Saint Paul

55318

GSK Investigational Site, Chaska

67005

GSK Investigational Site, Arkansas City

67207

GSK Investigational Site, Wichita

68131

GSK Investigational Site, Omaha

76104

GSK Investigational Site, Fort Worth

77030

GSK Investigational Site, Houston

78705

GSK Investigational Site, Austin

80027

GSK Investigational Site, Louisville

80045

GSK Investigational Site, Aurora

83642

GSK Investigational Site, Boise

84109

GSK Investigational Site, Salt Lake City

85224

GSK Investigational Site, Chandler

91790

GSK Investigational Site, West Covina

92083

GSK Investigational Site, Vista

92123

GSK Investigational Site, San Diego

94115

GSK Investigational Site, San Francisco

98418

GSK Investigational Site, Tacoma

98801

GSK Investigational Site, Wenatchee

99362

GSK Investigational Site, Walla Walla

01757

GSK Investigational Site, Milford

02886

GSK Investigational Site, Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00423046 - Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age | Biotech Hunter | Biotech Hunter