A phase 3, observer-blind, randomized, controlled study to evaluate the safety and immunogenicity of a booster dose of COVOVAX in Indian adults who have received primary vaccination against COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 372
- 试验地点
- 8
- 主要终点
- Anti-S IgG and Neutralizing antibodies
研究概览
简要总结
This is a Phase 3, observer-blinded, randomised, active controlled study in adults of more than or equal to 18 years of age in India who have already received primary vaccination against COVID-19 at least 6 months ago (6 months or 180 days from the second dose), to evaluate the immunogenicity and safety of the COVOVAX booster dose in comparison with the control vaccine.
A total of 372 eligible participants of ≥ 18 years of age who have completed primary 2 dose schedule of COVID-19 vaccination at least 6 months ago will be enrolled in this study in 2 cohorts of 186 participants each with 1:1 allocation to COVOVAX or control vaccine. Two cohorts of 186 participants each will be as below:
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COVISHIELD Prime cohort: Primary vaccination with two doses of COVISHIELD
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COVAXIN Prime cohort: Primary vaccination with two doses of COVAXIN
A total of 372 eligible participants (186 participants from each of 2 cohorts) will be randomized as mentioned above to receive study vaccines. The study vaccines will be injected intramuscularly in the deltoid as a single dose of 0.5 mL on Day 1. The participants will be observed closely for at least 30 minutes following vaccination.
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
- •Adults aged more than or equal to 18 years of either sex
- •Written informed consent by participants
- •Those who have completed primary COVID-19 vaccination schedule with at least 6 months ago
- •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 at the time of screening
- •History of laboratory confirmed COVID-19
- •History of allergic reactions after previous vaccinations including primary vaccination for COVID-19
- •Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw
- •Suspected or known current alcohol or drug dependence
- •Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period
- •Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period
- •Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine for until 28 days after study vaccination
- •Prior receipt of a booster dose of COVID-19 vaccine
- •Pregnant or breast-feeding
- •Acute or chronic, clinically significant systemic disorders
- •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant in the study or make it unlikely that the participant could complete the protocol.
结局指标
主要结局
Anti-S IgG and Neutralizing antibodies
时间窗: 28 days after vaccination
次要结局
- Occurrence of solicited local and systemic adverse events (AEs) for 7 days post-vaccination(7 days post-vaccination)
- Occurrence of unsolicited AEs for 28 days post-vaccination(28 days post-vaccination)
- Occurrence of SAEs, and adverse events of special interest (AESI) throughout the study duration following vaccination(180 Days Post Vaccination)
- Anti-S IgG and Neutralizing antibodies(at Day 91 and Day 181)