CTRI/2024/08/073010尚未招募不适用
A Prospective Randomized Single Center Two Arm Open Label Parallel Group Comparative Study to Evaluate the Safety of Needle Free Injection System (N-FIS TM) and Immunogenicity of Hexavalent Vaccine (HEXASIIL) in Healthy Infants Aged 15 to 18 Months
IntegriMedical Private Limited1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1 To evaluate the Safety of NFIS system
研究概览
简要总结
The design is a Prospective, randomized, single-center, two arm study to generate data for the evaluation of Safety and Immunogenicity [as measured by the trial participants who
experience Adverse Event/s (AE/s) &/or Serious Adverse Event/s (SAE/s) by using NIFSTM and assess the levels of antibodies concentration]. Trial participants will be assigned randomly to one of two groups, with a 1:1 ratio: either the intervention group (receiving HEXAVALENT vaccine via the intramuscular route using the NIFSTM) or the comparator group (receiving HEXAVALENT vaccine via traditional intramuscular injection).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Month(s) 至 18.00 Month(s)（—）
- 性别
- All
入选标准
- •1 Healthy infants either boys or girls aged 15 to 18 months at the time of enrollment 2 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 3 Infant with good general health as determined by the medical history physical examination and clinical judgment of the investigator 4 Informed Consent Assent Form (ICF) signed by the parent or any other Legally Acceptable Representative (LAR) 5 Subject and parent/legally acceptable representative are able to attend all scheduled visits and to 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 previous Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis and Haemophilus influenzae Type b Conjugate infection or Hexavalent (HEXASIIL) vaccination or if they had been exposed to any of these three diseases within 30 days of trial commencement 4 Subjects having received the Hexavalent (HEXASIIL) vaccine less than 3 months back 5 Subjects with a history of convulsions epilepsy other central nervous system diseases a 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 enrolment 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 Any bleeding disorder or receipt of anticoagulants in 3 weeks prior to the screening and randomization 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.
结局指标
主要结局
1 To evaluate the Safety of NFIS system
时间窗: 1 Day 1 to Day 28 | 2 Day 1 to Day 28
2 To evaluate the number of participants reporting solicited injection site reactions solicited or unsolicited systemic reactions
时间窗: 1 Day 1 to Day 28 | 2 Day 1 to Day 28
次要结局
- Evaluate the levels of antibody concentration to the vaccine antigens following a single dose of the HEXAVALENT vaccine(Day 1 to Day 28)
研究者
Dr Prashant Khandgave
Silver Birch Multispeciality hospital
研究点 (1)
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