Evaluation of the Efficacy, Safety and Immunogenicity of Inactivated COVID 19 Vaccine (TURKOVAC Inactive) in Healthy Population of 18 and 64 Years of Age (Both Inclusive): a Randomized, Double-blind, Phase IIb Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Efficacy Outcome
研究概览
简要总结
The objective of this study is to evaluate the efficacy, immunogenicity and safety of two different strengths (3 µg/0.5 mL and 4,5 µg/0.5 mL) of inactivated COVID 19 Vaccine- TURKOVAC in healthy subjects following 3rd vaccination to demonstrate clinical evidence in prophylaxis of COVID 19.
详细描述
This is a double-blind, triple dose, parallel, randomized design study comparing two different dose levels and immunization regimen of a novel COVID-19 vaccine candidate - TURKOVAC - against SARS-CoV-2 infection, to assess the efficacy and safety of these vaccine strengths after 3rd dose vaccination. This study will also provide more data to assess the efficacy of the 3rd dose vaccination (booster dose) for COVID-19 prophylaxis including comparison to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO).
This study will be completed in 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
3 μg / 0.5 mL
干预措施: Triple dose vaccination by inactivated Covid19 vaccine (Biological)
Arm 2
4,5 μg / 0.5 mL
干预措施: Triple dose vaccination by inactivated Covid19 vaccine (Biological)
结局指标
主要结局
Efficacy Outcome
时间窗: on day 14 and 28 after 3rd vaccination
comparison of neutralizing antibodies and cytokine (TNF-alpha, IFN-γ, IL-2, IL-4, IL-5 and IL-6) from pre- to post-vaccination
Efficacy outcome
时间窗: on day 14 and 28 after 3rd vaccination
• comparison of antibody responses levels of minimum of 40 participants to convalescent serum plasma obtained from WHO from pre- to post-vaccination
次要结局
- Safety outcome(12 months)