EUCTR2006-000764-85-FI进行中（未招募）不适用
A Open-label, Randomized, Multicenter Study of the Safety, Tolerability, andImmunogenicity of GARDASIL™ Given Concomitantly with REPEVAX™ in HealthyAdolescents 11-17 Years of Age
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
- All
入选标准
- •a. Healthy adolescent boys and girls age 11 to 17 years.
- •b. Must agree to provide study personnel with a primary telephone number as
- •well as an alternate telephone number for follow-up purposes.
- •c. Must agree to refrain from sexual activity throughout the course of the study
- •(including vaginal and anal penetration and any genital contact).
- •d. Subject must have been previously immunized against diphtheria, tetanus, and
- •pertussis (not in the last 5 years).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Individuals concurrently enrolled in clinical studies of investigational agents.
- •b. History of known prior vaccination with an HPV vaccine.
- •c. Receipt of inactivated vaccines within 14 days prior to enrollment or receipt
- •of live virus vaccines within 21 days prior to enrollment.
- •d. Has had coitarche or plans to become sexually active through the course of the
- •e. Temperature =100°F or =37.8°C (oral) within 24 hours prior to the first
- •f. Pregnant now (as determined by a urine pregnancy test sensitive to 25 IU
- •g. Individuals allergic to any of the vaccine components of GARDASIL™ or
- •REPEVAX™ or residues carried over from manufacture (such as
- •formaldehyde, streptomycin, neomycin, and polymoxin B). Individuals who
- •have experienced anaphylactic or other allergic reactions to a previous dose of
- •tetanus or diptheria or a component pertussis combination vaccine.
- •Individuals allergic to aluminum, yeast, phenoxyethanol, or BENZONASE™
- •(nuclease, Nycomed [used to remove residual nucleic acids from this and
- •other vaccines]).
- •i. Individuals who have received any immune globulin preparation (including
- •RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived products within
- •the 6 months prior to the first injection, or plan to receive any through the
- •completion of the study.
- •j. 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,
- •inhaled or nasal steroids will be eligible for vaccination.
- •k. Individuals with known hemophilia, thrombocytopenia or any coagulation
- •disorder that would contraindicate intramuscular injections.
- •l. Any condition which in the opinion of the investigator might interfere with the
- •evaluation of the study objectives.
- •m. Individuals who are immunocompromised or have been diagnosed as having
- •HIV infection.
- •n. History of recent (within 1 year from the date of enrollment) 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.
研究者
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