A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.0 个研究点目标入组 1,040 人开始时间: 2010年2月16日最近更新: 2012年4月18日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 1,040

研究概览入排标准研究者记录与标识符相似试验

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

•1. Subject is male or female, between the ages of 11 years and 0 days and 15 years and 364 days on the day of enrollment.
•2. Subject is judged to be in good physical health on the basis of medical history and physical examination.
•3. Parent/legal guardian and subject fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent/assent.
•4. Parent/legal guardian is able to read, understand, and complete the vaccination report card.
•5. Subject and parent/legal guardian agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
•6. Subject must not yet have had coitarche and does not plan on becoming sexually active through the course of the study.
•7. Subject must have previously received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5 year interval to a prior vaccination containing any one of these vaccine antigens.
•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

•1. Subject has a known allergy to any vaccine component of the 9-valent HPV L1 VLP vaccine, REPEVAX™ or residues carried over from manufacture (such as formaldehyde, glutaraldehyde, streptomycin, neomycin, and polymoxin B). Individuals allergic to aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). Subject experienced an allergy to a previous dose of tetanus, diphtheria, poliovirus (inactivated and/or oral poliovirus) or a component pertussis combination (acellular and whole cell) vaccine.
•2. Subject has had a severe reaction affecting the brain (e.g. evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine.
•3. Subject has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus (inactivated and/or oral poliovirus) or a component pertussis combination (acellular and whole cell) vaccine.
•4. Subject ever had Guillain-Barré syndrome (temporary loss of movement and feeling in all or part of the body) or brachial neuritis (loss of movement, pain and numbness of the arm and the shoulder) following a previous dose of a tetanus containing vaccine.
•5. Subject has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™.
•6. 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.
•7. Subject has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections.
•8. Subject is concurrently enrolled in clinical studies of investigational agents.
•9. (Female subjects only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
•10. 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.
•11. Subject has had a splenectomy.
•12. 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, monoclonal antibody therapies (including rituximab [Rituxan™]), 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 he/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, topical, or ocular steroids are considered eligible for the study.
•13. 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 the study.
•14. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine

研究者

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

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