A Phase 2/3, Observer-Blind, Randomized, Controlled Study to Determine the Safety and Immunogenicity of Covishield (COVID-19 Vaccine) in Healthy Indian Adults
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 14
- 主要终点
- 1. Occurrence of causally related SAEs throughout the study duration following vaccination
研究概览
简要总结
This is a Phase 2/3, observer-blind, randomised, controlled study in healthy adults in India, for comparison of the safety of COVISHIELD with Oxford/AZ-ChAdOx1 nCoV-19 and Placebo, and immunogenicity with Oxford/AZ-ChAdOx1 nCoV-19 in prevention of SARS CoV-2 infection. A total of 1600 eligible participants of more than or equal to 18 years of age will be enrolled the study. Of these 400 participants will be part of immunogenicity cohort and will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19, respectively. The remaining 1200 participants from safety cohort will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Placebo, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adults aged more than or equal to 18 years of either sex.
- •Written informed consent by participants.
- •The participant is resident of the study area and is willing to comply with study protocol requirements.
- •Healthy, as determined by medical history and physical examination.
- •Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.
排除标准
- •Acute illness with or without fever at the time of study vaccine administration
- •History of laboratory confirmed COVID-19 disease in household contact or close workplace contact
- •IgG seropositivity to SARS-CoV-2
- •History or currently positive for SARS-CoV-2 by RT-PCR
- •History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
- •Any confirmed or suspected condition with impaired/altered function of immune system.
结局指标
主要结局
1. Occurrence of causally related SAEs throughout the study duration following vaccination
时间窗: 1. Throughout the study duration following vaccination | 2. 28 days after the second | vaccination
2. Ratio of GMTs
时间窗: 1. Throughout the study duration following vaccination | 2. 28 days after the second | vaccination
of anti-S IgG antibodies
时间窗: 1. Throughout the study duration following vaccination | 2. 28 days after the second | vaccination
次要结局
- Occurrence of solicited local and/or systemic adverse events (AEs)(7 days following each vaccination)
- Occurrence of unsolicited adverse events(28 days following each vaccination)
- Occurrence of serious adverse events (SAEs)(Throughout the study duration following vaccination)