Clinical trial NCT00877877: Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Official title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Papillomavirus Vaccines
Keywords: HPV vaccine
cervical cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-04-08
Enrollment: 632
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives \& outcome measures of the extension phase from Month 60 to Month 120. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives \& outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).

Detailed description: Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study.

Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
* A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
* Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject.

Exclusion Criteria:

* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
* Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
* Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
* Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.

Primary outcomes:
measure: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
timeFrame: At Month 60
measure: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
timeFrame: At Month 72
measure: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
timeFrame: At Month 84
measure: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
timeFrame: At Month 96
measure: Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
timeFrame: At Month 60
measure: Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
timeFrame: At month 72
measure: Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
timeFrame: At Month 84
measure: Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
timeFrame: At Month 96
measure: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
timeFrame: At Month 108
measure: Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
timeFrame: At Month 108
measure: Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
timeFrame: At Month 120
measure: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
timeFrame: At Month 120
Secondary outcomes:
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 48 to Month 60
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 60 to Month 72
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 72 to Month 84
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 84 to Month 96
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 96 to Month 108
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 108 to Month 120
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Deggingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ettenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tauberbischofsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weilheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Buetzow
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Wolfenbuettel
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Willich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Harrislee
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Niebuell
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Weimar
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Tegucigalpa
country: Honduras
facility: GSK Investigational Site
state: Francisco Morazan
city: Arraijan/Vista Alegre
country: Panama
facility: GSK Investigational Site
state: Panamá
city: La Chorrera
country: Panama
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D. Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial. Pediatr Infect Dis J. 2014 Dec;33(12):1255-61. doi: 10.1097/INF.0000000000000460.
citation: Schwarz TF, Huang LM, Valencia A, Panzer F, Chiu CH, Decreux A, Poncelet S, Karkada N, Folschweiller N, Lin L, Dubin G, Struyf F. A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years. Hum Vaccin Immunother. 2019;15(7-8):1970-1979. doi: 10.1080/21645515.2019.1625644. Epub 2019 Jul 17.