TCTR20231108008尚未招募4 期
A Phase IV, Non-Inferiority, Double Blind, Randomized Controlled Clinical Trial comparing Safety and Immunogenicity of SII-Measles-Mumps-Rubella vaccine with Priorix (GSK) in healthy infants
MASU Co., Ltd0 个研究点目标入组 250 人开始时间: 2023年11月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 9 Months 至 12 Months（—）
- 性别
- All
入选标准
- •1)Normal healthy infants of age 9-12 months at the time of the screening and have not received their first dose of MMR vaccine.
- •2)Parents or legal guardians of participant willing to give written informed consent
- •3)Parents/legal guardians willing to comply with study protocol.
- •4)Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
- •5)The participant should be the resident of study area.
排除标准
- •1)Infant participating in other clinical trial or planned participation in another clinical trial during the present trial period.
- •2)Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy such as systemic corticosteroids therapy for a period of greater than or equal to 1 week.
- •3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances.
- •4)Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders such as autism.
- •5)Infant who has received blood or blood derived products in the past.
- •6)Clinical history of measles, mumps, or rubella infection.
- •7)Previous history of MMR vaccination.
- •8)Known history of a bleeding disorder or any condition that may be associated with prolonged bleeding time.
- •9)History of allergy to eggs, milk, neomycin or gelatin.
- •10)An acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) within the past 21 days.
- •11)Infants with leukemia, lymphoma, or any other cancer or neoplasm.
- •12)Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, neurological, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives.
- •13)Acute febrile illness at the time of vaccination (temporary exclusion criterion).
- •14)Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the participant could complete the protocol.
研究者
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