Status:
COMPLETED
Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cervical Cancer
Precancerous Condition
Eligibility:
FEMALE
18-25 years
Phase:
PHASE3
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus ...
Detailed Description
OBJECTIVES: Primary •Demonstrate the efficacy of the candidate vaccine, human papillomavirus 16/18 (HPV 16/18) L1 virus-like particle (VLP)/AS04 vaccine compared with control in preventing grade 2 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 30 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2010
Estimated Enrollment :
7466 Patients enrolled
Trial Details
Trial ID
NCT00128661
Start Date
June 30 2004
End Date
December 31 2010
Last Update
March 8 2019
Active Locations (1)
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1
Proyecto Epidemiologico Guanacaste
Liberia, Costa Rica