Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

September 12, 2011

Primary Completion Date

September 20, 2017

Study Completion Date

September 20, 2017

Conditions
Infections, Papillomavirus
Interventions
PROCEDURE

Gynaecological follow-up

Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.

BIOLOGICAL

Cervarix

Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

BIOLOGICAL

Placebo control

Subjects received 3 doses of the control \[Al(OH)3\] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Trial Locations (20)

52242

GSK Investigational Site, Iowa City

67207

GSK Investigational Site, Wichita

98801

GSK Investigational Site, Wenatchee

109263

GSK Investigational Site, Moscow

119074

GSK Investigational Site, Singapore

199034

GSK Investigational Site, Saint Petersburg

229899

GSK Investigational Site, Singapore

T6G 2C8

GSK Investigational Site, Edmonton

V6H 3N1

GSK Investigational Site, Vancouver

B3K 6R8

GSK Investigational Site, Halifax

B2N 1L2

GSK Investigational Site, Truro

J1H 1Z1

GSK Investigational Site, Sherbrooke

1007 MB

GSK Investigational Site, Amsterdam

3015 CE

GSK Investigational Site, Rotterdam

2805-267 Almada

GSK Investigational Site, Almada

3000-075 Coimbra

GSK Investigational Site, Coimbra

1200-831 Lisboa

GSK Investigational Site, Lisbon

2910-446 Setúbal

GSK Investigational Site, Setúbal

E1 1BB

GSK Investigational Site, London

M13 9WL

GSK Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01190176 - Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects | Biotech Hunter | Biotech Hunter