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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00877877
Ethics application status
Date submitted
26/03/2009
Date registered
8/04/2009

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
Human Genetics and Inherited Disorders 0 0 0 0
Down's syndrome
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Musculoskeletal 0 0 0 0
Osteoarthritis

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
Primary outcome [13] 0 0
Incidence of complications
Timepoint [13] 0 0
6mths post-surgery
Primary outcome [14] 0 0
Harris Hip score change at 6mths post-surgery
Timepoint [14] 0 0
6mths post-surgery
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
Secondary outcome [7] 0 0
Harris Hip Score
Timepoint [7] 0 0
3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [8] 0 0
Oxford Hip Score
Timepoint [8] 0 0
3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [9] 0 0
UCLA Activity Rating
Timepoint [9] 0 0
3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [10] 0 0
Incidence of post operative radiological signs
Timepoint [10] 0 0
7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [11] 0 0
Change in bone mineral density
Timepoint [11] 0 0
7days, 3mths, 6mths, 1yr and 2yrs post-surgery
Secondary outcome [12] 0 0
Kaplan-Meier Survivorship Calculations
Timepoint [12] 0 0
3 months, 6 months, and Annually

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
NA
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)
NSW
Recruitment hospital [1] 0 0
University of Sydney - St. Leonards
Recruitment hospital [2] 0 0
Royal Newcastle Hospital - Broadmeadow
Recruitment hospital [3] 0 0
Prince of Wales Private Hospital - Sydney
Recruitment hospital [4] 0 0
Sydney Adventist Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
- Broadmeadow
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
Colombia
State/province [2] 0 0
Bogota
Country [3] 0 0
Germany
State/province [3] 0 0
Baden-Wuerttemberg
Country [4] 0 0
Germany
State/province [4] 0 0
Bayern
Country [5] 0 0
Germany
State/province [5] 0 0
Mecklenburg-Vorpommern
Country [6] 0 0
Germany
State/province [6] 0 0
Niedersachsen
Country [7] 0 0
Germany
State/province [7] 0 0
Nordrhein-Westfalen
Country [8] 0 0
Germany
State/province [8] 0 0
Rheinland-Pfalz
Country [9] 0 0
Germany
State/province [9] 0 0
Schleswig-Holstein
Country [10] 0 0
Germany
State/province [10] 0 0
Thueringen
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Hamburg
Country [13] 0 0
Honduras
State/province [13] 0 0
Francisco Morazan
Country [14] 0 0
Panama
State/province [14] 0 0
Panamá
Country [15] 0 0
Panama
State/province [15] 0 0
La Chorrera
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taipei
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taoyuan
Country [18] 0 0
United States of America
State/province [18] 0 0
Massachusetts
Country [19] 0 0
United States of America
State/province [19] 0 0
Michigan
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Zlinsky kraj
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Ceske Budejovice
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Pecs
Country [33] 0 0
Ireland
State/province [33] 0 0
Dublin
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Italy
State/province [35] 0 0
Genova
Country [36] 0 0
Spain
State/province [36] 0 0
Catalonia
Country [37] 0 0
France
State/province [37] 0 0
Garches
Country [38] 0 0
Germany
State/province [38] 0 0
Frankfurt
Country [39] 0 0
Italy
State/province [39] 0 0
Jesi
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sequenom, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Johnson & Johnson
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD is available via the Clinical Study Data Request site (click on the link provided below)

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/Posting.aspx?ID=3315


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT00877877