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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/NCT01249365
Registration number
NCT01249365
Ethics application status
Date submitted
24/11/2010
Date registered
29/11/2010
Date last updated
13/11/2019
Titles & IDs
Public title
The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
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Scientific title
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study
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Secondary ID [1]
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2010-020227-48
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Secondary ID [2]
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113618
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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 (Cervarix)
Experimental: HPV vaccine - Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
Other interventions: GSK580299 (Cervarix)
3-dose schedule intramuscularly vaccination
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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 Reporting Serious Adverse Events
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Assessment method [1]
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Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
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Timepoint [1]
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Throughout the study (from Month 0 to Month 12)
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Primary outcome [2]
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Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
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Assessment method [2]
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Medically significant conditions (MSCs) are defined as:
AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination; SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Potential immune-mediated diseases (pIMDs) are a subset of medically significant conditions that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Any was defined as the occurrence of any MSC or pIMD regardless of intensity grade or relation to vaccination. Grade 3 MSC or pIMD = a MSC or pIMD which prevented normal, everyday activities. Related MSC or pIMD = a MSC or pIMD assessed by the investigator as related to the vaccination.
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Timepoint [2]
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Throughout the study (from Month 0 to Month 12)
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Primary outcome [3]
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Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
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Assessment method [3]
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Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Premature live infant NO apparent congenital anomaly; Premature live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Therapeutic abortion; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Spontaneous abortion congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Molar pregnancy; Pregnancy ongoing; Lost to follow up.
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Timepoint [3]
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Throughout the study (from Month 0 to Month 12)
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Eligibility
Key inclusion criteria
- Subjects who the investigator believes can and will comply with the requirements of
the protocol
- A subject previously enrolled in the study NCT00294047, who received the control
vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the
age for which the vaccine is licensed.
- Written informed consent obtained from the subject
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the
subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period
and 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 breastfeeding.
- A women planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the vaccination phase of the study, i.e.
up to two months after the last vaccine dose.
- Use of any investigational or non-registered product other than the study vaccine
within 30 days preceding the first dose of study vaccine, or planned use during the
study period.
- Previous vaccination against HPV or planned administration of another HPV vaccine
during the study other than that foreseen in the protocol.
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose.
- 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, with the exception of
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. Enrolment will be deferred until the subject
is outside of specified window.
- 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.
NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological
follow-up of the HPV-015 study, in which no investigational product will be administered.
Subjects will be invited to the gynaecological follow-up study if either of the following
applies:
- if they test positive for oncogenic HPV infection, but display normal cervical
cytology at their concluding HPV-015 study end visit;
- if they are pregnant so that no cervical sample can be taken at their concluding
HPV-015 study end visit;
- Previous administration of any components of the vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based
on medical history and physical examination.
- Cancer or autoimmune disease under treatment.
- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the
study period.
- History of any reaction or hypersensitivity likely to be exacerbated by any
component of the vaccine
- History of any neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or
renal functional abnormality, as determined by physical examination or laboratory
screening tests.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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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
24/01/2011
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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
10/01/2017
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Sample size
Target
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Accrual to date
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Final
199
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Parkville
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Recruitment hospital [2]
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GSK Investigational Site - Perth
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment postcode(s) [2]
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- Perth
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Recruitment outside Australia
Country [1]
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Portugal
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State/province [1]
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Almada
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Country [2]
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Portugal
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State/province [2]
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Coimbra
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Country [3]
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Portugal
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State/province [3]
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Lisboa
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Country [4]
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Portugal
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State/province [4]
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Porto
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Country [5]
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Portugal
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State/province [5]
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Setúbal
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Country [6]
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Russian Federation
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State/province [6]
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Ekaterinburg
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Country [7]
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Russian Federation
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State/province [7]
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Moscow
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Country [8]
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Russian Federation
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State/province [8]
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Sankt-Petersburg
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Country [9]
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Singapore
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State/province [9]
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Singapore
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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 extension study is designed to assess the safety of GSK Biological's HPV vaccine
GSK580299 in female subjects who took part in the primary study NCT00294047 and received the
control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the
subject's age group (26 years and older). This study is thus conducted to enable all women
who received the control placebo in the primary NCT00294047 study to receive the GSK580299
vaccine.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01249365
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Trial related presentations / publications
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Public notes
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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/NCT01249365
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