CTRI/2013/05/003702已完成4 期
A Phase IV, Non-Inferiority, Observer blind Randomized Clinical Study Comparing Safety And Immunogenicity Of Measles-Mumps-Rubella (MMR) Subcutaneous Vaccination By Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe For The Administration In Healthy Children In India Aged 15 To 18 Months.
Serum Institute of India Ltd0 个研究点目标入组 340 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 340
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
入选标准
- •1)Normal healthy infants of age 15-18 months at the time of the screening and have not received their first dose of MMR vaccine.
- •2)Previously received a measles monovalent vaccine at 9 months, as confirmed by the childhood vaccination record.
- •3)Parents or legal guardians of subject willing to give written informed consent and 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 subject 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.
- •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.
- •5)Infant who receive blood or bloodâ??derived products in the past.
- •6)Clinical history of measles, mumps, or rubella infection.
- •7)Previous history of MMR/MR combination vaccine or Rubella vaccine immunization.
- •8)Known history of a bleeding disorder or any condition that may be associated with prolonged bleeding time.
- •9)History of egg allergy to eggs, 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, 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)History of febrile illness at the time of vaccination is a 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 subject could complete the protocol.
研究者
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