An Open Label Single Centric Phase I Clinical Trial to evaluate the Safety and Immunogenicity of Japanese Encephalitis Vaccine Inactivated (Adsorbed, Human) I.P. of HBI when administered in two groups of Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
An Open Label Single Centric Phase I Clinical Trial to evaluate the Safety and Immunogenicity of Japanese Encephalitis Vaccine Inactivated (Adsorbed, Human) I.P. of HBI administered in two groups of Healthy Male Subjects of 18 to 49 years and 12 to below 18 years of age. The primary objectives are to evaluate the safety of Japanese Encephalitis Vaccine in two groups of healthy male subjects, proportion of the subjects experiencing local and/or systemic adverse events during follow up period in each age group and number of serious adverse events occurring during follow up period in each age group.
The secondary objective is to determine the Immunogenicity i.e. the humoral immune response after each dose of vaccination of Japanese Encephalitis Vaccine of HBI in two groups of Healthy male subjects of 18 to 49 years and 12 to below 18 years of age. Blood samples will be collected before the first dose of vaccination and 4-6 weeks after the second dose vaccination. The samples will be sent to central lab for analysis. The study will be conducted at one site.
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
- 12.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy male subjects of 18 to 49 years and 12 to below18 years of age.
- •Judged to be in good health based on reported medical history physical examination and clinical judgement of the investigator Subject or Parent or LAR is literate and has understood and signed the written informed consent prior to the study inclusion.
- •Subjects of 12 to below 18 years of age have provided Assent Plans to remain in the study area for the entire length of the trial.
排除标准
- •Past history of Japanese Encephalitis or Dengue infection History of receipt of licensed or experimental Japanese Encephalitis or Yellow Fever or Dengue vaccine Participation in another clinical trial in the four weeks preceding the trial vaccination Planned participation or planning to participate in any other clinical trial during the present trial period Subject who has a known history of allergy to any component of the vaccine Known or suspected primary or acquired disease of the immune system Allergy immunotherapy or receiving immunosuppressive therapy except for using topical steroids Subjects on treatment with any hepatotoxic drug before receiving the vaccine during the last 90 days History of any significant underlying disease including but not limited to malignancy cardiopulmonary disease renal endocrinologic hematologic or hepatic dysfunction Having diabetes mellitus type I or II Known or suspected acute respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea new cough pharyngitis and respiratory problems eg wheezing and shortness of breath Asthma that is unstable or required emergent care urgent care hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids Any fever with axillary temperature greater than equals to 38 Celsius 100 4 Fahrenheit in last 3 days Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms History of recent contact with any confirmed case of COVID 19 or having tested positive for COVID 19 since less than a month Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days Any known history of thrombocytopenia or a bleeding disorder History or suspicion of HIV HCV or Hepatitis B Any history of receipt of blood products in last 3 months Any condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.
结局指标
主要结局
Safety
时间窗: 4-6 weeks after second dose of vaccination.
Solicited/unsolicited local adverse events after each dose of vaccination and during the 4-6 weeks follow-up period in each age group.
时间窗: 4-6 weeks after second dose of vaccination.
Solicited/unsolicited systemic adverse events after each dose of vaccination and during the 4-6 weeks follow-up period in each age group.
时间窗: 4-6 weeks after second dose of vaccination.
Number of serious adverse events during the study period in each age group.
时间窗: 4-6 weeks after second dose of vaccination.
次要结局
- Immunogenicity(Seroprotection seroconversion rate in each group 4 to 6 weeks after the second dose of vaccination)
研究者
Dr Sai Krishna
Human Biologicals Institute