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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

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
Not applicable
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


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