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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00877877




Registration number
NCT00877877
Ethics application status
Date submitted
26/03/2009
Date registered
8/04/2009
Date last updated
18/01/2020

Titles & IDs
Public title
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Scientific title
Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
Secondary ID [1] 0 0
2008-000369-44
Secondary ID [2] 0 0
111375
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus 0 0
Papillomavirus Vaccines 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Blood sampling

Other: Cervarix Group - Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.


Treatment: Surgery: Blood sampling
Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Timepoint [1] 0 0
At Month 60
Primary outcome [2] 0 0
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Timepoint [2] 0 0
At Month 72
Primary outcome [3] 0 0
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Timepoint [3] 0 0
At Month 84
Primary outcome [4] 0 0
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Timepoint [4] 0 0
At Month 96
Primary outcome [5] 0 0
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Timepoint [5] 0 0
At Month 60
Primary outcome [6] 0 0
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Timepoint [6] 0 0
At month 72
Primary outcome [7] 0 0
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Timepoint [7] 0 0
At Month 84
Primary outcome [8] 0 0
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Timepoint [8] 0 0
At Month 96
Primary outcome [9] 0 0
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Timepoint [9] 0 0
At Month 108
Primary outcome [10] 0 0
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Timepoint [10] 0 0
At Month 108
Primary outcome [11] 0 0
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Timepoint [11] 0 0
At Month 120
Primary outcome [12] 0 0
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Timepoint [12] 0 0
At Month 120
Secondary outcome [1] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From Month 48 to Month 60
Secondary outcome [2] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From Month 60 to Month 72
Secondary outcome [3] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [3] 0 0
From Month 72 to Month 84
Secondary outcome [4] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [4] 0 0
From Month 84 to Month 96
Secondary outcome [5] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
From Month 96 to Month 108
Secondary outcome [6] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [6] 0 0
From Month 108 to Month 120

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
24 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/01/2015
Sample size
Target
Accrual to date
Final
632
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Bogota
Country [2] 0 0
Germany
State/province [2] 0 0
Baden-Wuerttemberg
Country [3] 0 0
Germany
State/province [3] 0 0
Bayern
Country [4] 0 0
Germany
State/province [4] 0 0
Mecklenburg-Vorpommern
Country [5] 0 0
Germany
State/province [5] 0 0
Niedersachsen
Country [6] 0 0
Germany
State/province [6] 0 0
Nordrhein-Westfalen
Country [7] 0 0
Germany
State/province [7] 0 0
Rheinland-Pfalz
Country [8] 0 0
Germany
State/province [8] 0 0
Schleswig-Holstein
Country [9] 0 0
Germany
State/province [9] 0 0
Thueringen
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Honduras
State/province [12] 0 0
Francisco Morazan
Country [13] 0 0
Panama
State/province [13] 0 0
Panamá
Country [14] 0 0
Panama
State/province [14] 0 0
La Chorrera
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00877877
Trial related presentations / publications
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.
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries