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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/NCT00799825




Registration number
NCT00799825
Ethics application status
Date submitted
26/11/2008
Date registered
1/12/2008
Date last updated
12/07/2018

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:
Infections, Papillomavirus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GSK Biological's HPV vaccine GSK580299 (Cervarix™)

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.


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
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)

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
N/A
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)
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

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 580299/008 and received the
control vaccine (Hepatitis A vaccine).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00799825
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