CTRI/2021/02/031554已完成2 期
A phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] in Indian adults aged =18 years and children aged 2 to 17 years - ICMR/SII-COVOVAX
Serum Institute of India Private Limited Pune0 个研究点目标入组 2,520 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,520
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
- •Adult Cohort:
- •1. Adults aged more than or equal to 18 years of either sex
- •2. Written informed consent by participants
- •3. The participant is resident of the study area and is willing to comply with study protocol requirements
- •4. Healthy, as determined by medical history and physical examination
- •5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit
- •6. Female participants of childbearing potential must have a negative
- •urine pregnancy test within 24 hours prior to study vaccine
- •Pediatric Cohort:
- •1. Children aged = 2 to 17 years of either sex
- •2. The participant is a resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study
- •3. Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator.
- •4. Parent(s) willing and able to give written informed consent for 2- to 17 year old children
- •5. Participants assent (verbal assent for 7- to 11-year old children and written assent for 12- to 17-year old children), as required, prior to study enrolment and to comply with study procedures.
- •6. Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test within 24 hours prior to study vaccine administration
排除标准
- •Adult Cohort:
- •1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration
- •2. History of laboratory confirmed (by PCR or serology to SARSCoV-2) COVID-19 disease.
- •3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
- •4. Prior receipt of an investigational or licensed vaccine likely to
- •impact interpretation of the trial data
- •5. Current or planned participation in prophylactic drug trials for the
- •duration of the study
- •Pediatric Cohort
- •1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration
- •2. History of laboratory confirmed (by PCR or serology to SARS-CoV-2) COVID-19 disease
- •3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
研究者
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