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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/NCT00849381
Registration number
NCT00849381
Ethics application status
Date submitted
19/02/2009
Date registered
23/02/2009
Date last updated
12/09/2014
Titles & IDs
Public title
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand
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Scientific title
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female Brazilian, Taiwanese and Thai Subjects Who Had Received Control Vaccine in Study 580299/008
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Secondary ID [1]
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111758
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - GSK580299, GSK Biological's HPV vaccine
Experimental: Cervarix Compliance Issue Centre Group - Subjects from one centre where compliance issues were discovered, who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study
Experimental: Cervarix All Centres Group - Subjects from all study centres who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
Other interventions: GSK580299, GSK Biological's HPV vaccine
All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
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Assessment method [1]
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Note: Results from one center where compliance issues were discovered are presented also separately.
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Timepoint [1]
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During the entire study period (up to Month 12)
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Primary outcome [2]
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Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
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Assessment method [2]
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MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
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Timepoint [2]
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During the entire study period (up to Month 12)
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Primary outcome [3]
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Number of Subjects With Pregnancies and Pregnancy Outcomes
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Assessment method [3]
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The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.
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Timepoint [3]
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During the entire study period (up to Month 12)
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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 26 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.
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Minimum age
26
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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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 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2012
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Sample size
Target
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Accrual to date
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Final
1239
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Rio Grande Do Sul
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Country [2]
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Brazil
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State/province [2]
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Campinas
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Country [3]
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Brazil
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State/province [3]
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Curitiba
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Country [4]
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Taiwan
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State/province [4]
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Taipei
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Country [5]
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Thailand
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State/province [5]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV
vaccine GSK580299 in female subjects who took part in study 008/580299 and received the
control vaccine (Hepatitis A vaccine).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00849381
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Trial related presentations / publications
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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
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00849381
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