A post-marketing surveillance study to evaluate the safety of Needle Free Injection System (N-FISTM) when administered with various types of vaccine for healthy infants aged below 6 months

IntegriMedical Private Limited2 个研究点分布在 1 个国家目标入组 500 人开始时间: 2024年9月28日最近更新: 2024年9月21日

试验速览

阶段: Unknown
状态: 招募中
发起方
入组人数: 500
试验地点: 2
主要终点: 1 To evaluate the Safety of Needle Free Injection System (N-FISTM) in terms of the

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single-arm, non-randomized, multicenter post-marketing surveillance study aimed at generating safety data for evaluating the Needle-Free Injection System (N-FISTM) when used with vaccines.

Safety will be assessed based on injection site reactions, Adverse Events (AEs), and Serious Adverse Events (SAEs) experienced by trial participants at three time points: within the first 30mins (at the hospital), Day 2 (Telephonic Follow Up), and Day 10 (Telephonic Follow up).

研究设计

研究类型: Observational

入排标准

年龄范围: 1.00 Month(s) 至 6.00 Month(s)（—）
性别: All

入选标准

•1 Healthy infants boys or girls aged less than 6 months will be included 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 Infant with good general health as determined by the medical history physical examination and clinical judgment of the investigator 4 Informed Consent or Assent Form (ICF) signed by the parent(s) or any other Legally Acceptable Representative (LAR) 5 Subject and parent/legally acceptable representative can attend all scheduled visits and comply with all trial procedures 6 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 convulsions, epilepsy other central nervous system diseases a severe disease of the haematopoietic system decompensated heart disease, or impaired renal function 4 Any other parenteral vaccine administration within 30 days of initiation of the study or during the study 5 A history of serious chronic illness major congenital defects immunosuppression (immunosuppressive illness or therapy) 6 Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months
•Subjects with any other clinically signiô€icant concurrent illness affecting immune response after vaccination 8 Subjects with an acute febrile illness at the time of enrolment/randomization
•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) 10 Known personal or maternal history of Human Immunodeô€iciency Virus (HIV) or hepatitis C seropositivity 11 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 12 Known thrombocytopenia, as reported by the parent/legally acceptable representative 13 Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating subcutaneous vaccination 14 In an emergency setting or hospitalized involuntarily 15 Chronic illness that in the opinion of the investigator is at a stage where it might interfere with trial conduct or completion 16 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) 17 History of seizures.