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 6 months to 24 months

IntegriMedical Private Limited3 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24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: 3
主要终点: 1 To evaluate the Safety of Needle Free Injection System in terms of the number of participants reporting

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

Itâ€™s 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: 6.00 Month(s) 至 24.00 Month(s)（—）
性别: All

入选标准

•Healthy infants boys or girls aged 6 months to 24 months will be included
•Born at full-term pregnancy (greater or equal to 37 weeks) with a birth weight greater or equal to 2.5 kg and preterm pregnancy with a birth weight greater or equal to 2.0 kg
•Infant with good general health as determined by the medical history physical examination and clinical judgment of the investigator
•Informed Consent or Assent Form signed by the parent(s)legal guardian or any other Legally Acceptable Representative
•Subject and parent or legally acceptable representative can attend all scheduled visits and comply with all trial procedures
•Confirmed through medical history to have been born to a mother who tested negative for hepatitis B surface antigen (HBsAg).

排除标准

•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
•Any vaccination administered within four weeks before the initial trial vaccination (excluding the Bacillus Calmette Guerin vaccine) or any vaccination expected to be administered within eight days before and eight days after each subsequent trial vaccination
•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
•Any other parenteral vaccine administration within 30 days of initiation of the study or during the study
•A history of serious chronic illness major congenital defects immunosuppression (immunosuppressive illness or therapy)
•Subjects who have received blood blood products or immunoglobulins during the preceding 3 months
•Subjects with any other clinically significant concurrent illness affecting immune response after vaccination
•Subjects with an acute febrile illness at the time of Enrollment or randomization
•Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy such as anticancer chemotherapy or radiation therapy since birth or longterm systemic corticosteroid therapy prednisone or equivalent for more than 2 consecutive weeks since birth
•Known personal or maternal history of Human Immunodeficiency Virus HIV or hepatitis C seropositivity
•Known systemic hypersensitivity to any of the vaccine components or history of a lifethreatening reaction to the trial vaccine or a vaccine containing the same substances
•Known thrombocytopenia as reported by the parent or legally acceptable representative
•Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating subcutaneous vaccination
•In an emergency setting or hospitalized involuntarily
•Chronic illness that in the opinion of the investigator is at a stage where it might interfere with trial conduct or completion
•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
•History of seizures.

结局指标

主要结局

1 To evaluate the Safety of Needle Free Injection System in terms of the number of participants reporting