EUCTR2011-004542-18-DK进行中（未招募）1 期
A Multicenter, Double-Blind Study of the Safety, Tolerability, andImmunogenicity of a Pneumococcal Conjugate Vaccine (V114)Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX™ 23) and Prevnar 13™ (Pneumococcal 13-Valent ConjugateVaccine [Diphtheria CRM197 Protein]) in Healthy Adults50 Years of Age or Older
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
- 690
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.Man or woman in good health.
- •2.Age =50 years.
- •3.Informed consent signed and dated prior to any study procedures being performed. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in the Future Biomedical Research.
- •4.Afebrile (<100.4oF [<38.0oC] oral or equivalent) for 72 hours prior to vaccination.
- •5.Subject is able to read, understand, and complete the study questionnaires (i.e., the VRC).
- •6.Subject is able to attend all scheduled visits and to comply with the study procedures.
- •7.Subject is highly unlikely to conceive at any time from signing the informed consent through 6 weeks after receiving the last dose of the study vaccine, as indicated by at least one yes” answer to the following questions:
- •a.Subject is male.
- •b.Subject is a female who agrees to remain abstinent or use (or have her partner use) 2 acceptable methods of contraception during the time period at any time from signing the informed consent through 6 weeks after receiving the study vaccine. Acceptable methods of birth control are: hormonal contraceptives, diaphragm with spermicide, intrauterine device (IUD), contraceptive sponge, condom, or vasectomy. Note that simultaneous use of 2 reliable forms of contraception is recommended.
- •c.Subject is a female who is not of reproductive potential. A female subject who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range as determined by a laboratory, or 12 months of spontaneous amenorrhea), (2) post-surgical bilateral oophorectomy and/or hysterectomy, or (3) bilateral tubal ligation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 460
排除标准
- •1.Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine.
- •2.Known hypersensitivity to any component of the pneumococcal conjugate vaccine or of the pneumococcal polysaccharide vaccine.
- •3.Known or suspected immunocompromised persons, including persons with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record =3 mg/dL), nephrotic syndrome, or other conditions associated with immunosuppression, such as organ or bone marrow transplant.
- •4.Functional or anatomic asplenia.
- •5.History of autoimmune disease.
- •6.Subject has a coagulation disorder contraindicating intramuscular vaccinations.
- •7.Subject has evidence of dementia or other cognitive impairment.
- •8.Subject has insufficient muscle mass in the deltoid muscle of either arm or an inability to grade limitation of arm movement as required with postvaccination clinical monitoring.
- •9.Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Subjects on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 30 days prior to Visit 1 through Visit 2, systemic doses greater than required for physiological replacement, i.e., >20 mg of prednisone (or equivalent) daily and for >2 weeks. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.
- •10.Any underlying illness that would complicate evaluation and completion of this study.
- •11.Any licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine. (Exception: Inactivated influenza vaccine may be administered during the study but must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine.
- •12.Subject has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine.
- •13.Subject has received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine.
- •14.Prior receipt of a blood transfusion or blood products including immune globulin administered within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
- •15.Investigational drugs or vaccines received within the 2 months before receipt of study vaccine or is scheduled to receive an investigational drug or vaccines within 30 days of receipt of study vaccine..
- •16.Subject intends to participate in another interventional clinical study anytime during the duration of the current clinical study (participation in an observational or safety surveillance study is acceptable).
- •17.History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease.
- •18.Subject has received antibiotic therapy for any acute illness within 72 hours before rec
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