Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants
Trial overview
Number of histopathologically confirmed Cervical Intraepithelial Neoplasia (CIN)2+ cases associated with HPV16 and/or HPV18 infection detected in the preceding cervical cytology specimen.
Timeframe: From Month 6 up to Month 48
Number of cervical infection with HPV16 or HPV18.
Timeframe: From Month 6 up to Month 48
Number of histopathologically confirmed CIN2+ cases associated with infection by any oncogenic HPV type
Timeframe: From Month 6 up to Month 48
Number of persistent infection (12-month definition) with human papillomavirus (HPV)-16 or HPV-18 cases
Timeframe: From Month 6 up to Month 48
Geometric mean titers (GMTs) for HPV-16 antibody in the immunogenicity subcohort.
Timeframe: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
Geometric mean titers (GMTs) for HPV-18 antibody in the immunogenicity subcohort
Timeframe: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal antibody Inhibition Test)
Timeframe: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal antibody Inhibition Test)
Timeframe: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48
Number of subjects reporting any and Grade 3 solicited local symptoms.
Timeframe: Within 60 minutes after vaccination
Number of subjects reporting any and Grade 3 solicited general symptoms.
Timeframe: Within 60 minutes after vaccination
Number of subjects reporting any and Grade 3 solicited local symptoms on a 10% random subset of participants.
Timeframe: From Day 3 to Day 6 after vaccination
Number of subjects reporting any and Grade 3 solicited general symptoms on a 10% random subset of participants.
Timeframe: From Day 3 to Day 6 after vaccination
Number of subjects reporting serious adverse events (SAEs).
Timeframe: During the entire study period (From Month 0 up to Month 48).
Number of subjects reporting unsolicited adverse events (AEs).
Timeframe: During the entire study period (From Month 0 up to Month 48).
Number of subjects with all possible pregnancy outcomes
Timeframe: During the entire study period (From Month 0 up to Month 48).
Number of cervical infection with HPV16 or HPV18.
Timeframe: During the first year of follow-up period
Number of cervical infection with HPV16 or HPV18.
Timeframe: During the second year of follow-up period
Number of cervical infection with HPV16 or HPV18.
Timeframe: During the third year of follow-up period
Number of cervical infection with HPV16 or HPV18.
Timeframe: From the fourth year follow-up period
Number of subjects reporting unsolicited adverse events (AEs).
Timeframe: within 30 days (Days 0-29) after vaccination
- DISEASE CHARACTERISTICS:
- Healthy participants
DISEASE CHARACTERISTICS: •Healthy participants ◦Deemed to be in good general health by history and physical examination •Resident of Guanacaste Province of Costa Rica and surrounding areas ◦Must remain a resident for ≥ 6 months after the first study vaccination PATIENT CHARACTERISTICS: Age •18 to 25 Performance status •Not specified Life expectancy •Not specified Hematopoietic •Not specified Hepatic •No history of chronic hepatitis requiring treatment •No acute or chronic clinically significant hepatic function abnormality by physical examination or laboratory findings •No known history of hepatitis A infection Renal •No history of kidney disease requiring treatment •No acute or chronic clinically significant kidney function abnormality by physical examination or laboratory findings Cardiovascular •No acute or chronic clinically significant cardiovascular function abnormality by physical examination or laboratory findings Pulmonary •No acute or chronic clinically significant pulmonary function abnormality by physical examination or laboratory findings Immunology •No history of allergic disease •No history of autoimmune disorder requiring treatment •No history of allergic reaction (e.g., difficulty breathing) to any vaccine •No suspected allergy or reaction likely to be exacerbated by a component of the study vaccines (e.g., 2-phenoxyethanol or neomycin) •No hypersensitivity to latex •No diagnosis or suspicion of any immunodeficient condition by medical history or physical examination Other •Not pregnant or nursing ◦No delivery within the past 3 months •Negative pregnancy test •Fertile patients must use effective contraception for 30 days before, during, and for 60 days after completion of study treatment •Able to speak or understand Spanish •Mentally competent •Able to undergo pelvic exam (i.e., no heavy bleeding [menstruation or otherwise] or heavy vaginal discharge) •No history of cancer requiring treatment •No history of diabetes requiring treatment •No history of other chronic conditions requiring treatment •No acute or chronic clinically significant neurologic function abnormality by physical examination or laboratory findings •No other acute disease •No fever ≥ 37.5º C PRIOR CONCURRENT THERAPY: Biologic therapy •More than 6 months since prior chronic administration (i.e., > 14 days) of immune-modulating drugs •More than 90 days since prior immunoglobulins •More than 30 days since prior and no other concurrent investigational or non-registered vaccines •More than 30 days since prior registered vaccines •More than 8 days since prior routine meningococcal, hepatitis B, influenza, or diphtheria/tetanus vaccine •No prior vaccination against hepatitis A •No prior vaccination against human papillomavirus •No prior monophosphoryl lipid A or AS04 adjuvant Chemotherapy •Not specified Endocrine therapy •More than 6 months since prior chronic administration (i.e., > 14 days) of corticosteroids (e.g., ≥ 0.5 mg/kg/day of prednisone or equivalent) •Concurrent inhaled or topical steroids allowed Radiotherapy •Not specified Surgery •No prior hysterectomy Other •More than 6 months since prior chronic administration (i.e., > 14 days) of immunosuppressants •More than 30 days since prior and no other concurrent investigational or non-registered drugs
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
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.