Study of a Multivalent Human Papillomavirus (HPV)
- Conditions
- Prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58.MedDRA version: 17.0Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2007-003528-39-AT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 14620
Inclusion criteria of PN001-00 to 03 (Base):
1. Subject is female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of randomization.
2. Subject has never had Pap testing or has only had normal Pap test results.
3. The subject has the following lifetime sexual history at the time of enrollment:
a) Subject has had 1 to 4 male and/or female sexual partners; or
b) Subject has had 0 male and/or female sexual partners, is 18 years of age or older, and plans to become sexually active within the first 3-6 months of the study.
4. Since the first day of the subject’s last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse).
Inclusion criteria for Extension protocol PN001-04 (Cohort 1):
- Subject was enrolled in Part B of the V503-001 base study , was randomized to the V503 cohort, and was in the Per-Protocol Immunogenicity population for at least one HPV type.
- Since the first day of the subject’s last menstrual period through Month 60, the subject has not had sex with males or has had sex with males and used effective contraception with no failures.
Inclusion criteria for Extension protocol PN001-04 (Cohort 2):
- Subject was enrolled in Part A or Part B of the V503-001 base study between 16 and 26 years of age, was randomized to the GARDASI cohort, and received at least 1 dose of GARDASIL.
- Since the first day of the subject’s last menstrual period through Month 60, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse).
Are the trial subjects under 18? yes
Number of subjects for this age range: 7310
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7310
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria of PN001-00 to 03 (Base):
1. Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse).
2. Subject has a history of a positive test for HPV.
3. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
4. Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
5. Subject has a history of or clinical evidence at the Day 1 pelvic examination of HPV-related external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer.
Exclusion criteria for Extension protocol PN001-04 (Cohort 1 & Cohort 2):
- Subject has known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™.
- Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
- Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- Subject is concurrently enrolled in clinical studies of investigational agents.
- Subject is pregnant.
- Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
- Subject has had a splenectomy.
- Subject is receiving or has received in the year prior to enrollment in the base study immunosuppressive therapies like radiation therapy, any chemotherapy, monocolonal antibody therapies (including rituximab), intravenous gamma globulin (IVIG) (for a compleze list see exclusion criteria 8 on page 18).
- Subject has received any immune globulin product or blood-derived product within the 3 months prior to the Month 60 vaccination, or (for Cohort 1 only) plans to receive any such product during Month 60 through Month 61 of the study.
- Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Month 60 vaccination or has received replicating (live) vaccines within 21 days prior to the Month 60 vaccination.
- Subject has received an HPV vaccine outside of the context of the V503-001 study.
- Subject has had a fever (defined as an oral temperature of =37.8°C) within the 24-hour period prior to the Month 60 vaccination.
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Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method