Observational Study to Evaluate the Effectiveness, Immunogenicity and Safety of Inactivated COVID-19 Vaccine (TURKOVAC) Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Incidence of adverse reactions
研究概览
简要总结
To assess the long-term safety of TURKOVAC in individuals who have not previously received the COVID-19 vaccine or who have received their primary vaccination with inactivated or mRNA vaccine, or who have received their primary vaccination with similarly inactivated or mRNA vaccine and who subsequently received the first dose or second dose of booster vaccine, who meet the inclusion/exclusion criteria of the study.
详细描述
The primary objective of the study was to evaluate the long-term safety of TURKOVAC in individuals who had never received a COVID-19 vaccine before, or who received their primary vaccination with inactivated or mRNA vaccine, or who received their primary vaccination with similarly inactivated or mRNA vaccine, and who subsequently received a first dose or second dose of booster vaccine, in individuals who met the inclusion/exclusion criteria of the study. The secondary objective of the study was to evaluate the immunogenicity of TURKOVAC in individuals who meet the inclusion/exclusion criteria of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet all of the following criteria will be included in the study:
- •Individuals aged 18 and over,
- •Individuals who have never had a COVID-19 vaccine before OR who have received COVID-19 mRNA or inactivated vaccines in the primary vaccination and have selected TURKOVAC as the booster dose (3rd dose and 4th dose),
- •Individuals who have not had COVID-19 during the last trimester,
- •Only for subjects who will receive 4th dose of vaccine: Those who have received the third dose of TURKOVAC vaccine and those who have spent at least 90 days since the third dose,
- •Individuals who agree to provide blood samples and verifiable identification information (in accordance with local regulations), who may be contacted by the investigator during the study and who may come into contact with the investigator,
- •Individuals who will be able to voluntarily understand and sign informed consent,
- •Individuals who accept phone calls to be made to them for the purpose of collecting safety-related data.
排除标准
- •Subjects who meet one of the following criteria will be excluded from the study.
- •For subjects who will receive primary vaccination: Individuals who have received any vaccine and/or flu vaccine within 14 days prior to the COVID-19 vaccine.
- •Individuals who have chosen a vaccine other than TURKOVAC as a booster dose.
结局指标
主要结局
Incidence of adverse reactions
时间窗: 3 - 7 days after vaccination
Incidence of adverse reactions in all subjects within 3 - 7 days after vaccination (phone call).
Incidence of Serious Adverse Events (SAE)
时间窗: 365 days after vaccination
Incidence of Serious Adverse Events (SAE) up to 365 days after vaccination in all subjects
次要结局
- Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels(Immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days of 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days))