EUCTR2009-015103-58-FI进行中（未招募）1 期
A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar™ in Healthy Adults and Toddlers
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
- 150
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
- •Adults =18 to 45 years of age in good health.
- •Afebrile (<100.4ºF[<38ºC] or equivalent) on day of vaccination.
- •Females must have a negative urine pregnancy test.
- •Healthy toddlers, 12-15 months of age who have previously completed a documented full 3 dose infant series of Prevnar™ at 2, 4, and 6 months of age.
- •Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C (<100.0°F) on day of vaccination.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Receipt of any pneumococcal polysaccharide vaccine at any time or receipt of polysaccharide conjugate vaccine after the second year of life.
- •Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
- •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), nephritic syndrome, or other conditions associated with immunosuppression such as organ or bone marrow transplant.
- •Functional or anatomic asplenia.
- •History of autoimmune disease.
- •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., >5 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.
- •Subject has received diphtheria toxoid within 6 months prior to receipt of study vaccine.
- •Prior receipt of a blood transfusion or blood products including immune globulin administered within the 6 months before receipt of study vaccine.
- •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.
- •History of febrile illness (=100.40 F [=38.00 C] oral or equivalent) occurring within 72 hours before receipt of study vaccine.
- •Subject is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. Female subjects of reproductive potential must have been using 2 acceptable methods of birth control for 2 weeks prior to enrollment, and agree to use 2 acceptable methods of birth control for 1 month after vaccination. (Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence).
- •Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
- •Have received less than the full 3-dose infant series of Prevnar™ or 3rd dose less than 2 months before study vaccine.
- •Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
- •Known or suspected impairment of immunological function.
- •Subject has a history of congenital or acquired immunodeficiency (e.g. splenomegaly).
- •Subject or his/her mother has documented HIV infection.
- •Functional or anatomic asplenia.
- •History of autoimmune disease.
- •Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. (Note: Toddlers on topical and inhaled/nebulized steroids may participate in the study.) Use of systemic steroids are only permitted when the subject is receiving less than 2mg/kg per day of prednisone (or its equivalent), or less than 20mg/d if they weigh more than 10kg and are not otherwise immunocompromised.
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins.
- •History of invasive pneumococcal d
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