EUCTR2010-019775-29-AT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™ 13 in Healthy Infants
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
- 1,110
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
入选标准
- •a.Healthy infants, age = 6 to = 12 weeks (= 42 days to = 89 days).
- •b.Subject's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
- •c.Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C (<100.0°F) on day of vaccination.
- •d.Subject’s parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
- •e.Subject is able to attend all scheduled visits and to comply with the study procedures.
- •f.Subject’s parent/legal guardian has access to a telephone
- •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
- •Prior administration of any pneumococcal 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 including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders.
- •Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders.
- •Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Subjects on intramuscular, oral, or intravenous corticosteroid treatment should be excluded if they are receiving or expected to receive in the period from 30 days prior to Visit 1 through Visit 6 (30 days PD4) more than 2 mg/kg per day of prednisone (or its equivalent), or more than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised. 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 other licensed non-live vaccines within the 14 days before receipt of study vaccine.
- •Subject has received a licensed live virus vaccine within the 30 days prior of receipt of study vaccine.
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins.
- •Investigational drugs or vaccines received within the 2 months before receipt of study vaccine.
- •Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study.
- •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.
- •A recent febrile illness (rectal temperature =38.1°C [=100.5°F]) occurring within 72 hours before receipt of study vaccine.
- •History of failure to thrive.
- •Subject and his/her mother have documented hepatitis B surface antigen-positive
研究者
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