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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00799825




Registration number
NCT00799825
Ethics application status
Date submitted
26/11/2008
Date registered
1/12/2008

Titles & IDs
Public title
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US
Scientific title
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008
Secondary ID [1] 0 0
111955
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 0 0
Infections, Papillomavirus 0 0
Depression 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GSK Biological's HPV vaccine GSK580299 (Cervarix™)
Treatment: Drugs - Metformin
Treatment: Drugs - Placebo
Treatment: Drugs - Metformin + Clomiphene
Treatment: Drugs - Metformin
Treatment: Drugs - Clomiphene
Treatment: Devices - Mobile Tracking Young People's Experiences (mobiletype)

Experimental: Cervarix group - Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.

Experimental: BMI > 32 - Women with BMI \> 32

Experimental: BMI </= 32 - Women with BMI \</= 32

Experimental: Mood monitoring - The mobiletype monitoring intervention group will monitor their current activities, current mood, responses to negative mood, any recent stressors and coping strategies. Other activities monitored include eating patterns, exercise patterns, quantity and quality of sleep and alcohol and cannabis use.

No intervention: Comparison monitoring program - The mobiletype monitoring comparison group will monitor their current activities, eating patterns, exercise patterns, quantity and quality of sleep and alcohol and cannabis use.

This program excludes questions about mood, stress and coping strategies.


Treatment: Other: GSK Biological's HPV vaccine GSK580299 (Cervarix™)
All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.

Treatment: Drugs: Metformin
500mg tds for 6 months

Treatment: Drugs: Placebo
One tablet tds for 6 months

Treatment: Drugs: Metformin + Clomiphene
500mg tds + Ovulatory dose for 6 months

Treatment: Drugs: Metformin
500mg tds for 6 months

Treatment: Drugs: Clomiphene
Ovulatory dose for 6 months

Treatment: Devices: Mobile Tracking Young People's Experiences (mobiletype)
A mobile phone self-monitoring program, based on momentary sampling techniques, that prompts young people to complete it four times a day. The program asks several questions about daily activities, mood, stress, eating and exercise.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Throughout the study (up to Month 12)
Primary outcome [2] 0 0
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Timepoint [2] 0 0
Throughout the study (up to Month 12)
Primary outcome [3] 0 0
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Timepoint [3] 0 0
Throughout the study (up to Month 12)
Primary outcome [4] 0 0
Clinical pregnancy
Timepoint [4] 0 0
within 6 calendar months of randomisation
Primary outcome [5] 0 0
Depressive symptoms
Timepoint [5] 0 0
Pre-, post-monitoring, 6-week follow up & 6 month follow-up
Primary outcome [6] 0 0
Emotional Self Awareness
Timepoint [6] 0 0
Pre-, post-, 6-weeks post- and 6-months post-test
Secondary outcome [1] 0 0
Live birth
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Adverse events
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Detection of mental health problems
Timepoint [3] 0 0
Pre-, post-monitoring, 6 week and 6 month follow up
Secondary outcome [4] 0 0
Pathways to care
Timepoint [4] 0 0
Pre-, post-monitoring, 6 week and 6 month follow up
Secondary outcome [5] 0 0
Patient's satisfaction with their GP
Timepoint [5] 0 0
Pre-, post-monitoring, 6 week and 6 month follow up

Eligibility
Key inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study
* A subject previously enrolled in the primary study (NCT00122681), who received the active control hepatitis A vaccine, and who cannot receive commercially available HPV-16/18 L1 VLP AS04 vaccine because the vaccine has not yet been granted licensure in the subject's country or because the subject is above the age for which the vaccine is licensed.
* Written informed consent must be obtained from the subject prior to enrolment.
* A woman aged 18 years or older, at the time of the first vaccination in this study.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.
* Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant or lactating female. Enrolment should be deferred until three months after pregnancy has been completed or after lactating has ceased.
* A woman planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the extended safety follow-up period.
* 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 non-investigational product (pharmaceutical product or device).
* Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen by protocol.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days (i.e. Day 0-29) of each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
* Previous administration of components of the investigational vaccine.
* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
* Hypersensitivity to latex.
* Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests, which in the opinion of the investigator precludes administration of the study vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Cancer or autoimmune disease under treatment.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Acute disease at the time of enrolment.

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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2012
Sample size
Target
Accrual to date
Final
346
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Clifton Hill Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3068 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
Newfoundland and Labrador
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
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Auckland Medical Research Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
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 for this study will be made available via the Clinical Study Data Request site.

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


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/NCT00799825