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
Completed
Completed
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:
Biological/vaccine: HPV-16/18 L1/AS04
Enrollment:
300
Observational study model:
Not applicable
Primary completion date:
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
- 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.
- Pregnant or breastfeeding.
- Previous vaccination against HPV.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
A female subject between, and including, 10 and 14 years of age at the time of the first vaccination.
Exclusion criteria:
- 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."
Pregnant or breastfeeding.
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
Completed
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website