Last updated: 11/03/2018 12:04:52
Safety study of GSK Biologicals’ HPV vaccine (GSK-580299) in healthy female subjects.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Safety study of GSK Biologicals’ human papillomavirus vaccine (GSK-580299) in healthy female subjects.
Trial description: This study will collect safety data of GlaxoSmithKline Biologicals’ human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects reporting any serious adverse event (SAE) and SAE(s) with a causal relationship to vaccination as assessed by the investigator.
Timeframe: During the entire study period (Day 0 up to the telephone contact at Month 12).
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
92
Primary completion date:
2010-09-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
May 2009 to September 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
25+ years
Accepts healthy volunteers
Yes
- Subjects enrolled in the primary study (NCT00306241) who received the placebo (aluminium hydroxide [Al(OH)3]).
- A female who is unable to receive all three doses of commercially available Cervarix before her 25th birthday.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study 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).
Inclusion and exclusion criteria
Inclusion criteria:
- A female who is unable to receive all three doses of commercially available Cervarix before her 25th birthday.
- Written informed consent obtained from the subject (prior to enrolment).
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects must have a negative urine pregnancy test.
- Subjects must be of non-childbearing potential or, if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for two months after completion of the vaccination series.
Subjects enrolled in the primary study (NCT00306241) who received the placebo (aluminium hydroxide [Al(OH)3]).
Exclusion criteria:
- 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).
- Pregnant or breastfeeding.
- 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.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
- Hypersensitivity to latex (found in syringe-tip cap and plunger).
- Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Previous administration of an adjuvant that used in the HPV-16/18 vaccine.
- Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
- Acute disease at the time of enrolment.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2010-09-09
Actual study completion date
2010-09-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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