CTRI/2024/01/061633招募中不适用
A Prospective, Randomized, Single-Center, Two Arm, Open Label, Parallel Group, Comparative Study to Evaluate the Safety of Needle Free Injection System (NFIS) and Immunogenicity of Tresivac MMR Vaccine in Healthy Infants using NFIS.
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1月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1)To evaluate the Safety of Needle Free Injection System (NFIS)
研究概览
简要总结
This 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 Needle Free Injection System (NFIS) and assess the levels of antibodies concentration] for 28 days
Trial participants will be assigned randomly to one of two groups, with a 1:1 ratio: either the intervention group (receiving Tresivac MMR vaccine using NFIS) or the comparator group (receiving Tresivac MMR vaccine using traditional subcutaneous injection).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 9.00 Month(s) 至 12.00 Month(s)（—）
- 性别
- All
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.
结局指标
主要结局
1)To evaluate the Safety of Needle Free Injection System (NFIS)
时间窗: (Pre vaccination) Day 1 to Day 28 (post-vaccination
(Note- safety in terms of Pain redness swelling itching observed at the injection site and any other adverse events or serious adverse events due to NFIS)
时间窗: (Pre vaccination) Day 1 to Day 28 (post-vaccination
2)To evaluate the number of participants reporting solicited injection site reactions solicited &/or unsolicited systemic reactions after administration of Tresivac MMR vaccine
时间窗: (Pre vaccination) Day 1 to Day 28 (post-vaccination
次要结局
- 1)Evaluate the levels of antibodies concentration to the vaccine antigens following single dose of Tresivac MMR vaccine((Pre vaccination) Day 1 to Day 28 (post-vaccination)
研究者
Mr Chandu Devanpally
Ardent Clinical Research Services
研究点 (1)
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