CTRI/2024/01/061633招募中Unknown
A Prospective, Randomized, Single-Center, Two Arm, Open Label, Parallel Group, Comparative Study to Evaluate the Safety of Needle Free Injection System (NFIS) and Immunogenicity of Tresivac MMR Vaccine in Healthy Infants using NFIS. - NI
IntegriMedical Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1 Healthy Infant(s) of 9 months to 12 months of age on the day of inclusion
- •2 Born at full term pregnancy (greater or equal to 37 weeks) with a birth weight greater or equal to 2.5 kg and pre-term pregnancy with a birth weight greater or equal to 2.0 kg
- •3 Informed Consent Form (ICF) signed by the parent(s) or any other Legally Acceptable Representative (LAR)
- •4 Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •5 Confirmed through medical history to have been born to a mother who tested negative for hepatitis B surface antigen (HBsAg)
排除标准
- •1 Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine drug medical device or medical procedure
- •2 Any vaccination administered within four weeks before the initial trial vaccination (excluding the Bacillus Calmette-Guerin [BCG] vaccine) or any vaccination expected to be administered within eight days before and eight days after each subsequent trial vaccination.
- •3 Subjects with a history of previous measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement.
- •4 Subjects having received measles vaccine less than 3 months back.
- •5 Subjects with a history of convulsions epilepsy other central nervous system diseases severe disease of haematopoietic system decompensated heart disease or impaired renal function
- •6 Any other parenteral vaccine administration within 30 days of initiation of the study or during the study
- •7 A history of serious chronic illness major congenital defects immunosuppression (immunosuppressive illness or therapy)
- •8 Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months
- •9 Subjects with any other clinically significant concurrent illness affecting immune response after vaccination
- •10 Subjects with an acute febrile illness at the time of enrollment/randomization
- •11 Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- •12 Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
- •13 Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- •14 Known thrombocytopenia as reported by the parent/legally acceptable representative
- •15 Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
- •16 In an emergency setting or hospitalized involuntarily
- •17 Chronic illness that in the opinion of the investigator is at a stage where it might interfere with trial conduct or completion
- •18 Identified as a natural or adopted child of the Investigator relatives or employee with direct involvement in the proposed study (To avoid conflict of interest in the study)
- •19 History of seizures
研究者
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