CTRI/2022/04/042017已完成3 期
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 - COVOVAX-Booster
Serum Institute of India Private Limited Pune0 个研究点目标入组 372 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 372
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adults aged more than or equal to 18 years of either sex
- •2. Written informed consent by participants
- •3. Those who have completed primary COVID-19 vaccination schedule with at least 6 months ago
- •4. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration
排除标准
- •1. Acute illness at the time of screening
- •2. History of laboratory confirmed COVID-19
- •3. History of allergic reactions after previous vaccinations including primary vaccination for COVID-19
- •4. Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw
- •5. Suspected or known current alcohol or drug dependence
- •6. Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period
- •7. 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
- •8. 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
- •9. Prior receipt of a booster dose of COVID-19 vaccine
- •10. Pregnant or breast-feeding
- •11. Acute or chronic, clinically significant systemic disorders
- •12. 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
研究者
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