CTRI/2009/091/000787暂停3 期
Evaluation of Tolerability and Immunogenicity of GARDASIL in Healthy Females, Between 16 and 26 Years of Age, in India
Merck Sharp and Dohme0 个研究点目标入组 600 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •o Healthy married females between 16 and 26 years of age with intact uteri.
- •o No clinical evidence of gross purulent cervicitis (otherwise postpone until after treatment or lack of laboratory confirmation of treatable cause).
- •o Must agree to refrain from sexual activity (including vaginal and anal penetration and any genital contact) for 48 hours prior to any scheduled visit that includes a pelvic examination in an attempt to avoid detection of viral DNA which has been deposited in the vagina or on the perineal/perianal area during sexual intercourse and is not the result of ongoing infection.
- •o Not pregnant now (as determined by a serum pregnancy test or urine pregnancy test sensitive to 25 IU b HCG), and must agree to use effective contraception through Month 7 of the study.
- •o Must agree to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
- •o Individuals who have had sexual intercourse in the 2 weeks prior to enrollment must have been using effective contraception as defined above (Emergency contraception is not considered effective contraception for enrollment into the study)
排除标准
- •o Individuals concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
- •o History of known prior vaccination with an HPV vaccine.
- •o Subject has received non-replicating (inactivated) vaccine within 14 days prior to the Day 1 vaccination or has received replicating (live virus) vaccine within 21 days prior to the Day 1 vaccination.
- •o Individuals with any prior abnormal Pap test showing squamous intraepithelial lesion (SIL), ASCUS, ASC-US, ASC-H.
- •o Individuals with a history of genital warts.
- •o Individuals allergic to any vaccine component, including aluminium, yeast, or BENZONASE? (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]).
- •o Individuals who have received any immune globulin preparation or blood-derived products within the 3 Months prior to the first injection, or plan to receive any through the completion of the study.
- •o Individuals with a history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of systemic corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled or nasal) will be eligible for vaccination. Individuals who are immunocompromised or have been diagnosed as having HIV infection
- •o Individuals with known thrombocytopenia or any coagulation disorder that would
- •contraindicate intramuscular injections.
- •o Any condition which in the opinion of the investigator might interfere with the
- •evaluation of the study objectives.
- •o Any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
- •o History of recent or ongoing alcohol 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.
- •o Inability to give consent/assent.
- •o Feverish feeling within 24 hours prior to the first injection and no temperature 100°F or 37.8°C (oral or oral equivalent) at first vaccination
研究者
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