A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

1,080

Participants

Timeline

Start Date

August 22, 2022

Primary Completion Date

February 23, 2024

Study Completion Date

February 25, 2024

Conditions
Cervical Intraepithelial Neoplasia
Interventions
BIOLOGICAL

HPV9 High formulation

3 doses of the high formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.

BIOLOGICAL

HPV9 Medium formulation

3 doses of the medium formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.

BIOLOGICAL

HPV9 Low formulation

3 doses of the low formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.

BIOLOGICAL

Gardasil 9

3 doses of the marketed HPV vaccine (Gardasil 9) were administered intramuscularly at Day 1, Month 2 and Month 6.

Trial Locations (68)

1431

GSK Investigational Site, Sofia

1606

GSK Investigational Site, Sofia

8661

GSK Investigational Site, Vilnius

10128

GSK Investigational Site, Tallinn

10617

GSK Investigational Site, Tallinn

19055

GSK Investigational Site, Schwerin

21000

GSK Investigational Site, Dijon

21075

GSK Investigational Site, Elkridge

23502

GSK Investigational Site, Norfolk

27612

GSK Investigational Site, Raleigh

29405

GSK Investigational Site, North Charleston

30328

GSK Investigational Site, Atlanta

33060

GSK Investigational Site, Pompano Beach

33125

GSK Investigational Site, Miami

33134

GSK Investigational Site, Coral Gables

33162

GSK Investigational Site, North Miami Beach

34239

GSK Investigational Site, Sarasota

34741

GSK Investigational Site, Kissimmee

35000

GSK Investigational Site, Rennes

37000

GSK Investigational Site, Tours

37404

GSK Investigational Site, Chattanooga

38043

GSK Investigational Site, La Tronche

40509

GSK Investigational Site, Lexington

43213

GSK Investigational Site, Columbus

44093

GSK Investigational Site, Nantes

46617

GSK Investigational Site, South Bend

47712

GSK Investigational Site, Evansville

48602

GSK Investigational Site, Saginaw

49387

GSK Investigational Site, Kaunas

50106

GSK Investigational Site, Tartu

50708

GSK Investigational Site, Tartu

65109

GSK Investigational Site, Jefferson City

66606

GSK Investigational Site, Topeka

67205

GSK Investigational Site, Wichita

68701

GSK Investigational Site, Norfolk

70433

GSK Investigational Site, Covington

73072

GSK Investigational Site, Norman

75010

GSK Investigational Site, Carrollton

75062

GSK Investigational Site, Irving

75251

GSK Investigational Site, Dallas

75679

GSK Investigational Site, Paris

76104

GSK Investigational Site, Fort Worth

77065

GSK Investigational Site, Houston

77338

GSK Investigational Site, Humble

77346

GSK Investigational Site, Humble

77375

GSK Investigational Site, Tomball

78229

GSK Investigational Site, San Antonio

78412

GSK Investigational Site, Corpus Christi

80033

GSK Investigational Site, Wheat Ridge

84088

GSK Investigational Site, West Jordan

85025

GSK Investigational Site, La Roche-sur-Yon

87102

GSK Investigational Site, Albuquerque

89102

GSK Investigational Site, Las Vegas

92120

GSK Investigational Site, San Diego

97074

GSK Investigational Site, Würzburg

160000

GSK Investigational Site, Prague

92103-6204

GSK Investigational Site, San Diego

CZ-500 03

GSK Investigational Site, Hradec Králové

772 00

GSK Investigational Site, Olomouc

779 00

GSK Investigational Site, Olomouc

LT-48259

GSK Investigational Site, Kaunas

LT-49456

GSK Investigational Site, Kaunas

LT-50177

GSK Investigational Site, Kaunas

85-796

GSK Investigational Site, Bydgoszcz

30-348

GSK Investigational Site, Krakow

91-363

GSK Investigational Site, Lodz

96-100

GSK Investigational Site, Skierniewice

00-215

GSK Investigational Site, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY