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
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,520
- 试验地点
- 23
- 主要终点
- Occurrence of causally related serious
研究概览
简要总结
This is a Phase 2/3,observer-blinded, randomized, controlled study in adults ≥ 18 years andchildren of ≥ 2 to 17 years of age in India.
Adult Cohort:
A total of 1600eligible participants of ≥ 18 years of age will be enrolled in this study. Ofthese, 460 participants will be part of reactogenicity and immunogenicitycohort. The remaining 1140 participants will be part of safety cohort.
All eligibleparticipants (n=1600) will receive two doses of 0.5 mL each of either COVOVAXor Control vaccine (Novavax- SARS-CoV-2 rS with Matrix-M1â„¢ Adjuvant) or Placeboon Day 1 and Day 22 as per randomization. Post vaccination site visits areplanned on Day 22, Day 36, Day 85 and Day 180.
The study will beconducted in two parts as below:
Phase 2 part: Initial200 participants have been enrolled in the Safety cohort with 3:1 allocation toCOVOVAX (n=150) or Placebo (n=50).
Phase 3 part:Enrolment of remaining 1400 participants (940 from the Safety cohort and 460from the reactogenicity and immunogenicity cohort) will be done.
Pediatric cohort:
The study objective inthis cohort is to evaluate the safety of COVOVAX in comparison with Placebo;and immunogenicity of COVOVAX in children ≥ 12 to 17 years of age and ≥ 2 to 11years of age in comparison with adult participants (adult participants in thereactogenicity and immunogenicity cohort from COVOVAX group), separately.
A total of 920eligible children of ≥ 2 years of age will be enrolled in this study. Of these,460 participants will be of ≥ 12 to 17 years of age and 460 participants willbe of ≥ 2 to 11 years of age.
All eligibleparticipants (n=920) will be randomized in 3:1 ratio to receive two doses of0.5 mL each of either COVOVAX or Placebo, respectively, on Day 1 andDay 22.
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
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Cohort:
- •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
- •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
- •Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine Pediatric Cohort:
- •Children aged ≥ 2 to 17 years of either sex
- •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
- •Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator.
- •Parent(s) willing and able to give written informed consent for 2- to 17 year old children
- •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.
- •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:
- •Acute illness including COVID-19 with or without fever at the time of study vaccine administration
- •History of laboratory confirmed (by PCR or serology to SARSCoV-2) COVID-19 disease.
- •History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
- •Prior receipt of an investigational or licensed vaccine likely to impact interpretation of the trial data
- •Current or planned participation in prophylactic drug trials for the duration of the study Pediatric Cohort 1.
结局指标
主要结局
Occurrence of causally related serious
时间窗: Throughout the study follow up period | 14 days after second vaccination (35 days post first dose vaccination) | For 7 days following each dose | 35 days post first dose vaccination | Throughout the study period following vaccination
a. Ratio of GMEUs of anti-Spike (S) protein IgG and Ratio of GMTs of NAb against SARS CoV-2
时间窗: Throughout the study follow up period | 14 days after second vaccination (35 days post first dose vaccination) | For 7 days following each dose | 35 days post first dose vaccination | Throughout the study period following vaccination
Safety Outcomes:
时间窗: Throughout the study follow up period | 14 days after second vaccination (35 days post first dose vaccination) | For 7 days following each dose | 35 days post first dose vaccination | Throughout the study period following vaccination
adverse events (SAEs) throughout the study duration following vaccination
时间窗: Throughout the study follow up period | 14 days after second vaccination (35 days post first dose vaccination) | For 7 days following each dose | 35 days post first dose vaccination | Throughout the study period following vaccination
Immunogenicity Outcomes:
时间窗: Throughout the study follow up period | 14 days after second vaccination (35 days post first dose vaccination) | For 7 days following each dose | 35 days post first dose vaccination | Throughout the study period following vaccination
a. Occurrence of solicited local and systemic AEs
时间窗: Throughout the study follow up period | 14 days after second vaccination (35 days post first dose vaccination) | For 7 days following each dose | 35 days post first dose vaccination | Throughout the study period following vaccination
次要结局
- Occurrence of solicited local and systemic adverse events (AEs)(7 days following each dose)
- Occurrence of SAEs, related(MAAEs, and adverse events of)
- Pediatric cohort:(Immunogenicity Outcomes:)
- Occurrence of unsolicited adverse(events including medically attended)
- GMEUs of anti-S IgG antibodies(Baseline, Day 21, Day 35 and Day 179 post first dose vaccination)
- b. GMTs of NAb against SARS-CoV-2
- Seroconversion for anti-S IgG(Day 21, Day 35 and Day 179 post first dose vaccination)