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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
111758
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
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
During the entire study period (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
During the entire study period (up to Month 12)
Primary outcome [3] 0 0
Number of Subjects With Pregnancies and Pregnancy Outcomes
Timepoint [3] 0 0
During the entire study period (up to Month 12)

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.
Minimum age
26 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 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
Non-randomised trial
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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
1239
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Rio Grande Do Sul
Country [2] 0 0
Brazil
State/province [2] 0 0
Campinas
Country [3] 0 0
Brazil
State/province [3] 0 0
Curitiba
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taipei

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

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00849381
Trial related presentations / publications
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00849381