Last updated: 11/03/2018 08:40:49
A study to evaluate the immunogenicity and safety of GSK Biologicals' HPV vaccine in healthy women aged 18-35 years
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase III, double-blind, randomized, controlled study to evaluate immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine, administered intramuscularly (0, 1, 6 month schedule) in healthy females aged 18 – 35 years
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 immune response induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA)
Timeframe: At Month 7
Secondary outcomes:
Occurrence of SAEs
Timeframe: Throughout the study period (up to Month 7)
Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms
Timeframe: During the 7 days after each and any vaccination
Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms
Timeframe: Within 30 days after any vaccination
Occurrence of new onset chronic diseases and other medically significant conditions regardless of causal relationship to vaccination and intensity.
Timeframe: Throughout the study period (up to Month 7)
Anti-HPV-16/18 antibody titres (by ELISA)
Timeframe: At Month 0 and Month 7
Interventions:
Biological/vaccine: HPV-16/18 L1 VLP AS04
Enrollment:
300
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ngan HY et al. (2010) Human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in healthy Chinese women from Hong Kong. Hong Kong Med J. 16(3): 171-179.
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)
March 2006 to June 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18 - 35 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A female of Chinese origin, residing in Hong Kong aged between, and including, 18 and 35 years at the time of the first vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study/ control vaccine within 30 days preceding the first dose of study/ control vaccine, or planned use during the study period.
- Pregnant or breastfeeding.
Inclusion and exclusion criteria
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 female of Chinese origin, residing in Hong Kong aged between, and including, 18 and 35 years at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects must have a negative urine pregnancy test.
- Subjects of childbearing potential at the time of study entry must be abstinent or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study/ control vaccine within 30 days preceding the first dose of study/ control vaccine, or planned use during the study period.
- Pregnant or breastfeeding.
- Planning to become pregnant or likely to become pregnant.
- 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 before and 30 days after the first dose of vaccine. Administration of routine vaccines up to 8 days before the first 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.
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/ control vaccines.
- Hypersensitivity to latex.
- Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- History of chronic condition(s) requiring treatment.
- Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/ control vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
- Acute disease at the time of enrolment.
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
2007-16-06
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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