A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL™, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26-Year-Old Wome
- Conditions
- -B977 Papillomavirus as the cause of diseases classified to other chaptersPapillomavirus as the cause of diseases classified to other chaptersB977
- Registration Number
- PER-064-07
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 785
• The participant is a woman, between 16 years of age and 0 days and 26 years and 364 days on the day of randomization.
• Participants have never had a Pap test or have only had normal Pap test results.
• The participant (or, for underage participants, the parent / legal guardian and the participant) fully understand the study procedures, available alternative treatments, the risks involved with the study and voluntarily accept to participate by providing written informed consent.
• The participant is able to read, understand and complete the vaccination report card.
• The participant is considered to be in good physical health based on medical history, physical examination and laboratory results.
• The participant presents the following sexual history throughout her life at the time of enrollment: a) The participant has had 1 to 4 sexual partners of male and / or female sex; or b) The participant has had 0 sex partners of male and / or female sex, is 18 years of age or older and plans to become sexually active within the first 3 months of the beginning of the study.
• The participant has abstained from showering / vaginal hygiene or using drugs or vaginal preparations for 2 calendar days prior to the Day 1 visit. The participant agrees to abstain from these activities for 2 calendar days prior to any future visit that includes the collection of samples for the study (cervical / genital smear, Pap test or tissue collection for definitive therapy / biopsy).
• The participant has abstained from having sexual activity (including anal, vaginal or genital / genital contact with either the same sex or the opposite sex) for 2 calendar days before the Day 1 visit. The participant agrees to abstain from these activities for 2 calendar days prior to any future visit that includes the collection of samples for the study (cervical / genital smear, pap smear or tissue collection for definitive therapy / biopsy).
• The participant has not had sex with men from the first day of her last menstrual period until Day 1, or she has had sex with men and has used effective contraceptives without problems (an example of a problem is the rupture of a condom male during intercourse). Effective contraception is defined as an approved, contracted contraceptive product that the participant has used following the manufacturer´s instructions in each of their sexual relationships. The participant understands and accepts that during the period from Day 1 to Month 7, she should not have sex with men without effective contraception, and that the use of the rhythm method alone, the withdrawal alone or the Emergency contraception are not acceptable methods according to the protocol.
• The participant has an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia (CIN) or worse).
• The participant presents a positive test history for HPV.
• The participant is, at the moment of signing the informed consent, user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. A person who abuses alcohol consumption is defined as one who takes alcohol despite their social, interpersonal and / or legal problems caused by the use of alcohol.
• The participant has a history of severe allergic reaction (for example, swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
• The participant has a known allergy to any component of the vaccine, including aluminum, yeast, or BENZONASE ™ (nuclease, Nycomed ™ [used to remove residual nucleic acids from this and other vaccines]). For purposes of this exclusion criteria, an allergy to a component of the vaccine is defined as an allergic reaction that met the criteria for serious adverse events defined in Section 3.4.
• The participant is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bladder disease or another autoimmune condition
• The participant has undergone a splenectomy.
• The participant is receiving or has received, in the year prior to enrollment, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporine, leflunomide (Arava ™), TNF-a antagonists, antibody therapies monoclonal antibodies (including rituximab [Rituxan ™]), intravenous gamma globulin (IVIG), antilymphocyte serum, or other therapy known to interfere with the immune response. With respect to systemic corticosteroids, a participant will be excluded if she is currently receiving steroid therapy, has recently received (defined as within 2 weeks prior to enrollment) such therapy, or has received 2 or more cycles of corticosteroids in high doses (orally or parenterally) with a duration of at least 1 week in the year prior to enrollment. Participants who use inhaled, nasal or topical corticosteroids are considered eligible for the study.
• The participant has received any immunoglobulin product (including RlioGAM [Ortho-Clinical Diagnostics, Inc.]) or blood products within 3 months prior to the Day 1 vaccination, or plans to receive such product during the period from Day 1 through Month 7 of the study.
• The participant has received non-replicative (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicative vaccines (live virus) within 21 days prior to the Day 1 vaccination.
• The participant has thrombocytopenia or any coagulation disorder that could contraindicate intramuscular injections.
• The participant has donated blood within the week prior to the Day 1 vaccination or intends to do so during the period from Day I to Month 7 of the study.
• The participant expects to donate eggs during the period from Day 1 to Month 7 of the study.
• The participant is currently enrolled in clinical studies of agents in research or in studies that include the collection of cervical samples.
• The participant has received
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:It is defined that this endpoint has occurred if a participant is positive for the same type of HPV through the PCR assay for HPV 31/33/45/52/58 to at least 1 common gene in 2 or more external cervicovaginal / genital samples. , of biopsy or definitive therapy obtained with at least 6 months of difference (within the windows of ± 1 month).<br>Measure:Combined incidence of persistent infection by<br>HPV 31, 33, 45, 52 and 58 for 6 months<br>Timepoints:6 months<br>
- Secondary Outcome Measures
Name Time Method