Last updated: 11/07/2018 02:34:52
Immunogenicity and safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) vaccine 580299 in healthy females 15 - 25 years of age
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity and safety study of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15-25 years
Trial description: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. 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:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Timeframe: One month after the third vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Timeframe: One month after the third vaccine dose
Secondary outcomes:
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Timeframe: One month after the second vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Timeframe: One month after the second vaccine dose
Number of Subjects Reporting Solicited Local Symptoms
Timeframe: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Solicited General Symptoms
Timeframe: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Timeframe: During the 30-day (Days 0-29) period following each vaccination
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset autoimmune diseases (NOADs), serious adverse events (SAEs), and Medically Significant Conditions (MSCs)
Timeframe: During the entire study period (up to Month 18 or up to Month 12)
Number of subjects with pregnancies and their outcomes
Timeframe: During the entire study period (up to Month 18 or Month 12)
Number of subjects completing the 3-dose vaccination schedule
Timeframe: After the third vaccine dose
Interventions:
Biological/vaccine: Cervarix TM
Enrollment:
805
Observational study model:
Not applicable
Primary completion date:
2009-26-02
Time perspective:
Not applicable
Clinical publications:
Esposito S et al. (2011) Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine administered according to an alternative dosing schedule compared with the standard dosing schedule in healthy women aged 15 to 25 years: results from a randomized study. Pediatr Infect Dis J. 30(3):e49-55.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
November 2007 to July 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
15 - 25 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol
- A female between and including 15 and 25 years of age at the time of the first vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol
- A female between and including 15 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject’s parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and/or clinical examination before entering into the study.
- Subject must be of non-childbearing potential, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
- Subject who had no more than 6 lifetime sexual partners prior to enrolment.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- 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. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the patient 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 (pharmaceutical product or device).
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- previous administration of components of the investigational vaccine
- Cancer or autoimmune disease under treatment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- Pregnant or breastfeeding female.
- Female planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period starting at visit one and up to two months after the last vaccine dose.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or lab tests.
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
Completed
Actual primary completion date
2009-26-02
Actual study completion date
2009-20-07
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.
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