PER-076-04已完成未知
A STUDY TO EVALUATE THE EFFICACY OF TETRAVALENT VACCINE AGAINST HPV (TYPES 6,11,16,18) OF SIMILAR PARTICLES TO VIRUS (VLP) L1 TO REDUCE THE INCIDENCE OF ANOGENITARIAN WARTS RELATED TO HPV 6,11, 16 AND 18 AND THE INCIDENCE OF GENITAL INFECTION RELATED TO HPV 6,11,16 AND 18 IN MEN BETWEEN 16 AND 23 YEARS OF AGE.
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 250 人开始时间: 2004年12月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 250
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
- 年龄范围
- 0 至 0（—）
入选标准
- •Healthy men between 16 years and 0 days and 23 years and 364 days.
- •No clinical evidence of macroscopic genital lesion suggesting a sexually transmitted disease without clinically present anogenital warts.
- •They should not have a temperature> 100 ° F or> 37.8 ° C (oral) within 24 hours before vaccinations (vaccinations can be scheduled for a later date when the temperature falls within the normal range).
- •They must agree to abstain from sexual activity (including vaginal and anal penetration and any genital contact) for 2 calendar days before any of the visits that include obtaining samples, to avoid detection of viral DNA that has been deposited in the genital area of the man during sexual intercourse and that is not the result of an ongoing infection.
- •Individuals who have initiated sexual activity but who have not had more than 5 sexual partners in the course of their life.
- •They must agree to provide the study staff with a primary telephone number as well as an alternate telephone number for follow-up purposes.
- •Additional inclusion criteria for heterosexual individuals Individuals must be heterosexual men, who have had exclusively female partners. Additional inclusion criteria for MSM individuals Individuals must have had anal intercourse either insertive or receptive with another man as a sexual partner within the previous year.
排除标准
- •Individuals concurrently enrolled in clinical studies of research agents or studies that involve obtaining genital samples.
- •History of a previous known vaccination with a vaccine against HPV.
- •Have received inactivated vaccines within 14 days prior to enrollment or have received live virus vaccines within 21 days prior to enrollment.
- •Individuals who have a history of anogenital warts or who have anogenital warts clinically present on Day 1.
- •History of a severe allergic reaction (for example, swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
- •Individuals allergic to any component of the vaccine, including aluminum, yeast, or BENZONASE ™ (nucleasea Nycomed [used to remove residual nucleic acids from this and other vaccines]).
- •Individuals who have received any immunoglobulin or blood products within 6 months prior to the first injection, or who plan to receive one until Month 7 of the study.
- •Individuals with a history of splenectomy, known immune disorders (eg, systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressants (eg, substances or treatments known to decrease the immune response such as radiation therapy, administration of antimetabolites) , antilymphocytic serums, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressants, defined as at least 3 courses of oral corticosteroids, each of at least 1 week in duration during the year prior to enrollment, will be excluded. Individuals who use topical steroids (ie, inhaled or nasal) will be eligible for vaccination.
- •Individuals who are immunocompromised or who have been diagnosed with infection with Human Immunodeficiency Virus (HIV).
- •Individuals with known thrombocytopenia or any coagulation disorder that may have intramuscular injections as a contraindication.
- •History of alcohol use or recent or ongoing drug abuse (within the last 12 months). Alcohol or drug abuse is defined as taking or using drugs despite recurring social, interpersonal and legal problems resulting from this use of alcohol or drugs.
- •Any disorder that in the opinion of the investigator could interfere with the evaluation of the study objectives.
- •Any plans to permanently move out of the area before completing the study or leaving the area for a prolonged period of time during which study visits would need to be scheduled.
- •Individuals with less than one or> 5 sexual partners in the course of their life.
- •Inability to give informed consent / acceptance.
研究者
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