EUCTR2017-001443-13-Outside-EU/EEA进行中（未招募）1 期
A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made with an Alternative Manufacturing Process (AMP)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
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. In good health, based on medical history (physical examination is not required).
- •b. Twelve (12) to 23 months of age upon receipt of the first study vaccination (subject is able to enroll from the day of his/her first birthday up to 1 day prior to his/her second birthday).
- •c. A negative clinical history for measles, mumps, rubella, varicella, and zoster.
- •d. Subject’s legal representative understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- •e. Subject’s legal representative is able to read, understand, and complete study questionnaires (i.e., VRC).
- •f. Subject is able to complete all scheduled visits and comply with the study procedures.
- •g. The subjects’ parent/legal guardian may also provide written informed consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1400
- •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
- •If a subject meets any of the exclusion criteria marked with an asterisk (*), the Day 1 visit may be rescheduled for a time when these criteria are no longer met.
- •a. Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study.
- •b. *Vaccinated with a licensed, non-live vaccine (e.g., Inactivated Poliovirus [IPV], Diphtheria, Tetanus, and Acellular Pertussis [DTaP], Haemophilus influenzae type b [Hib]) 14 days or less prior to any dose of the study vaccines or expected to be vaccinated with a licensed, non-live vaccine during the 42-day safety follow-up period after each vaccination in this study.
- •c. *Vaccinated with any licensed live vaccine within 30 days prior to any dose of the study vaccines or expected to be vaccinated with a licensed live vaccine other than the study vaccines during the 42-day safety follow-up period after each vaccination during in this study.
- •d. Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study.
- •e. The subject had an exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination involving: Continuous household contact, or Playmate contact (generally >1 hour of play indoors), or Hospital contact (in the same 2- to 4- bed room or in adjacent beds in a large ward or prolonged contact with an infectious staff member or patient), or In the case of varicella, contact with a newborn whose mother had onset of chickenpox 5 days or less before delivery or within 48 hours after delivery.
- •f. Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use (See Exclusion Criterion g) or other immunosuppressive therapy.
- •g. Subject has received 1) systemic immunomodulatory steroids [greater than the equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to entering the study, or 2) any dose of systemic immunomodulatory steroids within 7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study.
- •h. A history of allergy or anaphylactiod reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines.
- •i. Subject has received salicylates (e.g., aspirin or any aspirin-containing products) within 14 days prior to vaccination.
- •j. A diagnosis of an active neurological disorder. Enrollment may be considered when the disease process has been stabilized.
- •k. History of seizure disorder, including single febrile seizure.
- •l. Diagnosis of active untreated tuberculosis.
- •m. *A recent (<72 hours) febrile illness (=102.0°F [=38.9°C] oral equivalent) prior to the study vaccination.
- •n. History of thrombocytopenia.
- •o. Subject was born to an HIV-infected mother.
- •p. Subject’s legal representative is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
- •q. Any other underlying medical condition that, in the opinion of the investigator, may interfere with the evaluation of study objectives.
- •r. Currently participating in or sche
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