Last updated: 11/07/2018 01:00:43
Evaluate the immunogenicity & safety of GSK Biologicals' HPV vaccine in female subjects aged 10-14 years
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluate the immunogenicity & safety of GSK Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0,1,6 mth schedule in healthy female subjects aged 10–14 yrs
Trial description: Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 – 14 years in Korea.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
Timeframe: Not Applicable.
Secondary outcomes:
To evaluate safety and reactogenicity throughout the study period.
Timeframe: Not Applicable.
Interventions:
Enrollment:
300
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kim YJ et al. (2010) Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10–14 years. J Korean Med Sci. 25(8):1197-1204.
Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
November 2005 to August 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
10 - 14 years
Accepts healthy volunteers
Yes
- Inclusion criteria:
- A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
Inclusion and exclusion criteria
Inclusion criteria:
- A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
- Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment.
- Subjects must have a negative urine pregnancy test.
- Healthy subject before entering the study as established by medical history and clinical examination.
- Subject must be of non-childbearing potential. Exclusion criteria:
- Pregnant or breastfeeding.
- Previous vaccination against HPV.
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality
- History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease."
Inclusion criteria:
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-05-08
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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