EUCTR2017-000109-19-Outside-EU/EEA进行中（未招募）1 期
A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL™, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 23-Year-Old Women.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 680
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Subjects should meet all inclusion criteria. For items with an asterisk (*), if the subject does not meet these inclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria can be met.
- •a. Subject is between the ages of 16 years and 0 days and 23 years and 364 days on the day of randomization.
- •b. Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, agrees to participate in the study, and has given written informed consent.
- •c. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
- •d. Subject has a lifetime history of 0 to 4 sexual partners (male and/or female). Male partner is defined as someone with whom the subject has penetrative sexual intercourse. Female partner is defined as someone who has contacted, either by penetrative (with fingers or other objects) or non-penetrative means, the subject's genitalia during sexual activity.
- •e. *Subject has refrained from douching/vaginal cleansing and using vaginal medications or preparations for 2 days prior to the Day 1 visit. Subject agrees to refrain from these activities for 2 days prior to any future visit that includes collection of study specimens (cervical/genital swabs, Pap test, or
- •biopsy/definitive therapy tissue).
- •f. *Subject has refrained from sexual activity (including anal, vaginal, or genital/genital contact whether same sex or opposite sex) for 2 days prior to the Day 1 visit. Subject agrees to refrain from these sexual activities for 2 days prior to any future visit that includes collection of study specimens (cervical/genital swabs, Pap test, or biopsy/definitive therapy tissue).
- •g. *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). Effective contraception is defined as a marketed, approved contraceptive product that the subject has used per the manufacturer’s instructions with every act of sexual intercourse. The subject understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable methods per the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 136
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 544
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •To be randomized and receive the first study vaccination, subjects should not have any exclusion criteria. For items with an asterisk (*), if the subject meets these exclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria are not met.
- •a. Subject has a history of an abnormal Pap test (showing ASC-US or worse) or an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse).
- •b. Subject has never had a history of an abnormal Pap test, but has a history of a positive test for HPV.
- •c. Subject has a history of recent (within 1 year from the date of enrollment) or ongoing alcohol abuse or other drug abuse. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and legal problems as a result of alcohol use.
- •d. 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.
- •e. Subject has known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for serious adverse experiences defined in Section I.G.
- •f. 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.
- •g. Subject has had a splenectomy.
- •h. Subject is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), TNF-a antagonists, Rituximab (Rituxan™), monocolonal antibody therapies, intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. Subjects using
- •inhaled, nasal, or topical corticosteroids are considered eligible for the study.
- •i. Subject has received any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
- •j. * Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live virus) vaccines within 21 days prior to the Day 1 vaccination.
- •k. Subject has thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
- •l. Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens.
- •m. Subject has a history of participation in an HPV vaccine clinical trial and has received either active agent or placebo.
- •n. Subject has a history of any disease or condition which, in the investiga
研究者
相似试验
进行中（未招募）
1 期
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 Women.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: 18.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862EUCTR2007-003528-39-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA14,620
进行中（未招募）
1 期
A Randomized, International, Double-Blinded (With In-House Blinding), ControlledWith GARDASIL™, Tolerability, Immunogenicity, and Efficacy Study of a SecondGeneration Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) VaccineAdministered to 16- to 26-Year-Old WomePrevention of cervical, vulvar, and vaginal cancers and related precancers, externalgenital lesions, and persistent infection caused by Human Papillomavirus (HPV) 6, 11,16, 18, 31, 45, 52, and 58.MedDRA version: 8.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionEUCTR2006-004933-14-DKMerck & Co., Inc.4,000
已完成
不适用
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-B977 Papillomavirus as the cause of diseases classified to other chaptersPapillomavirus as the cause of diseases classified to other chaptersB977PER-064-07MERCK SHARP & DOHME PERU S.R.L.,785
进行中（未招募）
1 期
A Randomized, International, Double-Blinded (With In-HouseBlinding), Controlled With GARDASIL™, Dose-Ranging, Tolerability,Immunogenicity, and Efficacy Study of a Multivalent HumanPapillomavirus (HPV) L1 Virus-Like Particle (VLP) VaccineAdministered to 16- to 26-Year-Old Women - FUTURE 9EUCTR2007-003528-39-DKMerck & Co. Inc.14,620
进行中（未招募）
不适用
An International Study of an HPV Vaccine in 16- to 26-Year-Old WomeEUCTR2007-003528-39-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.14,620