此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

在 18 岁及以上成人中针对 COVID-19 的单价和二价重组蛋白疫苗的研究 (VAT00008)

2026年5月6日 更新者：Sanofi Pasteur, a Sanofi Company

一项平行组、III 期、多阶段、改良双盲、多组研究，以评估两种 SARS-CoV-2 佐剂重组蛋白疫苗（单价和二价）预防 COVID 的功效、安全性和免疫原性-19 在 18 岁及以上的成年人中作为主要系列和开放标签扩展，以评估单价加强剂量的 SARS-CoV2 佐剂重组蛋白疫苗的免疫原性、安全性和功效

这项 III 期研究的目的是评估两种 CoV2 preS dTM-AS03 疫苗（单价和二价）的有效性、安全性和免疫原性，作为多阶段方法初级系列疫苗接种的一部分，以及加强注射CoV2 preS dTM-AS03 疫苗，适用于 18 岁及以上的成年人。

计划总共招募大约 21046 名参与者（第 1 阶段每个研究干预组 5080 人，第 2 阶段每个研究干预组 5443 人）。

初始、双盲、初级系列研究设计计划在每个参与者的最后一次初始注射后 365 天（即，总共大约 386 天）进行。

根据研究监督小组的决定，第 1 阶段和第 2 阶段的参与者将被邀请参加非盲交叉/助推器研究设计，持续时间如下：

  • 对于最初接种疫苗的参与者：加强后 12 个月（即大约 18 至 24 个月）
  • 对于最初接受安慰剂的参与者：主要系列的最后一剂后 ≥ 4 个月 + 加强剂后 12 个月（即，大约 28 至 34 个月）
  • 对于不同意继续研究的非盲交叉/助推器部分的参与者，将停止所有研究程序并且参与者将停止研究。

研究概览

地位

终止

条件

干预/治疗

详细说明

每个参与者参与研究的初始、双盲、主要系列设计的持续时间为最后一次注射后约 365 天（即，总共约 386 天）。

根据研究 OG 的决定，第 1 阶段和第 2 阶段的参与者将被邀请参加非盲交叉/助推器研究设计，持续时间如下：

  • 对于最初接种疫苗的参与者：加强后 12 个月（即大约 18 至 24 个月）
  • 对于最初接受安慰剂的参与者：主要系列的最后一剂后 ≥ 4 个月 + 加强剂后 12 个月（即，大约 28 至 34 个月）
  • 对于不同意继续研究的非盲交叉/助推器部分的参与者，将停止所有研究程序并且参与者将停止研究。

研究类型

介入性

注册 (实际的)

23670

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Kiev、乌克兰、04210
        • Investigational Site Number : 8040002
      • Kyiv、乌克兰、01023
        • Investigational Site Number : 8040004
      • Kyiv、乌克兰、02002
        • Investigational Site Number : 8040003
      • Kyiv、乌克兰、03037
        • Investigational Site Number : 8040001
  • 乌干达
      • Entebbe、乌干达
        • Investigational Site Number : 8000002
      • Entebbe、乌干达
        • Investigational Site Number : 8000005
      • Kampala、乌干达
        • Investigational Site Number : 8000001
      • Kampala、乌干达、10101
        • Investigational Site Number : 8000013
      • Kampala、乌干达、23491
        • Investigational Site Number : 8000007
      • Kampala、乌干达、42 Nakasero Road
        • Investigational Site Number : 8000003
      • Kampala、乌干达、Plot 101, Lubowa
        • Investigational Site Number : 8000004
      • Lira、乌干达、10101
        • Investigational Site Number : 8000014
  • 加纳
      • Kintampo、加纳、P. O. Box 200
        • Investigational Site Number : 2880002
      • Kumasi、加纳、00000
        • Investigational Site Number : 2880003
      • Navrongo、加纳、114
        • Investigational Site Number : 2880001
  • 印度
      • Ajmer、印度、305001
        • Investigational Site Number : 3560010
      • Ambawadi、印度、380015
        • Investigational Site Number : 3560002
      • Belagavi、印度、590002
        • Investigational Site Number : 3560007
      • Jaipur、印度、302039
        • Investigational Site Number : 3560001
      • Kanpur、印度、208002
        • Investigational Site Number : 3560005
      • Nagpur、印度、440001
        • Investigational Site Number : 3560009
      • Odisha、印度、751003
        • Investigational Site Number : 3560011
      • Patna、印度、801507
        • Investigational Site Number : 3560004
      • Punjagutta、印度、500082
        • Investigational Site Number : 3560003
      • Tamilnadu、印度、603203
        • Investigational Site Number : 3560006
  • 哥伦比亚
      • Aguazul、哥伦比亚、856018
        • Investigational Site Number : 1700010
      • Barranquilla、哥伦比亚、080020
        • Investigational Site Number : 1700002
      • Barranquilla、哥伦比亚、080020
        • Investigational Site Number : 1700008
      • Bogotá、哥伦比亚、111611
        • Investigational Site Number : 1700001
      • Cali、哥伦比亚、76001
        • Investigational Site Number : 1700005
      • Chía、哥伦比亚、0000
        • Investigational Site Number : 1700006
      • Floridablanca、哥伦比亚、681004
        • Investigational Site Number : 1700004
      • Girardot、哥伦比亚、252431
        • Investigational Site Number : 1700007
      • Meta、哥伦比亚、0000
        • Investigational Site Number : 1700009
      • Quindío、哥伦比亚、630001
        • Investigational Site Number : 1700015
      • Soledad、哥伦比亚、083001
        • Investigational Site Number : 1700003
  • 墨西哥
      • Temixco、墨西哥、62587
        • Investigational Site Number : 4840006
      • Veracruz、墨西哥、91910
        • Investigational Site Number : 4840002
    • Guanajuato
      • León、Guanajuato、墨西哥、37000
        • Investigational Site Number : 4840005
    • Guerrero
      • Acapulco de Juárez、Guerrero、墨西哥、39670
        • Investigational Site Number : 4840004
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44280
        • Investigational Site Number : 4840003
    • Mexico City
      • Mexico City、Mexico City、墨西哥、04530
        • Investigational Site Number : 4840009
    • Morelos
      • Cuernavaca、Morelos、墨西哥、62290
        • Investigational Site Number : 4840008
  • 尼泊尔
      • Dhulikhel、尼泊尔、45200
        • Investigational Site Number : 5240002
      • Kathmandu、尼泊尔、44600
        • Investigational Site Number : 5240003
      • Nepalgunj、尼泊尔、21900
        • Investigational Site Number : 5240001
  • 日本
    • Tokyo
      • Chiyoda-ku,、Tokyo、日本、101-0041
        • Investigational Site Number : 3920005
      • Haramachi,Shinjuku-ku、Tokyo、日本、162-0053
        • Investigational Site Number : 3920004
      • Kouenji minami,Suginami-ku、Tokyo、日本、166-0003
        • Investigational Site Number : 3920003
      • Kyobashi Chuo-ku、Tokyo、日本、104-0031
        • Investigational Site Number : 3920001
      • Ohta-ku、Tokyo、日本、143-0015
        • Investigational Site Number : 3920002
  • 洪都拉斯
      • Municipio Del Distrito Central、洪都拉斯、11101
        • Investigational Site Number : 3400001
      • San Pedro Sula、洪都拉斯、21104
        • Investigational Site Number : 3400002
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35211
        • AES - DRS - Simon Williamson Clinic, PC - Birmingham- Site Number : 8400004
      • Huntsville、Alabama、美国、35802
        • Optimal Research Alabama- Site Number : 8400019
    • California
      • Rolling Hills Estates、California、美国、90274
        • Peninsula Research Associates, Inc.- Site Number : 8400021
    • Colorado
      • Centennial、Colorado、美国、80112
        • Synexus Clinical Research US, Inc. Site Number : 8400013
    • Florida
      • Melbourne、Florida、美国、32934
        • Optimal Research, LLC-Melbourne- Site Number : 8400002
      • Orlando、Florida、美国、32806
        • Synexus Clinical Research US, Inc. - Orlando- Site Number : 8400020
      • Pinellas Park、Florida、美国、33781
        • AES St. Petersburg- Site Number : 8400017
    • Georgia
      • Atlanta、Georgia、美国、30328
        • Synexus Clinical Research US, Inc. - Atlanta- Site Number : 8400005
    • Illinois
      • Chicago、Illinois、美国、60602
        • Synexus Clinical Research Chicago- Site Number : 8400012
    • Indiana
      • Evansville、Indiana、美国、47714
        • Synexus Clinical Research Evansville- Site Number : 8400008
    • Missouri
      • St Louis、Missouri、美国、63141
        • Synexus St. Louis- Site Number : 8400006
    • Nevada
      • Henderson、Nevada、美国、89052
        • Synexus Clinical Research US, Inc. - Henderson- Site Number : 8400018
    • New York
      • Rochester、New York、美国、14609
        • Rochester Clinical Research, Inc.- Site Number : 8400023
    • Ohio
      • Akron、Ohio、美国、44311
        • Synexus Akron- Site Number : 8400009
      • Cincinnati、Ohio、美国、45236
        • Synexus Clinical Research US, Inc. - Cincinnati- Site Number : 8400010
      • Columbus、Ohio、美国、43212
        • Synexus US Columbus- Site Number : 8400011
    • South Carolina
      • Anderson、South Carolina、美国、29621
        • Synexus Clinical Research Anderson- Site Number : 8400007
      • North Charleston、South Carolina、美国、29405
        • Coastal Carolina Research Center - N Charleston- Site Number : 8400022
    • South Dakota
      • Rapid City、South Dakota、美国、57701
        • American Indian Clinical Trials Research Network Site Number : 8400025
    • Texas
      • Austin、Texas、美国、78744
        • AES Austin- Site Number : 8400003
      • Dallas、Texas、美国、75231
        • Synexus Dallas- Site Number : 8400014
      • San Antonio、Texas、美国、78229
        • Synexus Clinical Research US, Inc. - San Antonio- Site Number : 8400015
    • Utah
      • Murray、Utah、美国、84123
        • AES Salt Lake City- Site Number : 8400016
  • 肯尼亚
      • Butere、肯尼亚、50101
        • Investigational Site Number : 4040011
      • Eldoret、肯尼亚、30100
        • Investigational Site Number : 4040006
      • Kericho、肯尼亚、00200
        • Investigational Site Number : 4040004
      • Kisumu、肯尼亚、40100
        • Investigational Site Number : 4040002
      • Kisumu、肯尼亚、40100
        • Investigational Site Number : 4040003
      • Kisumu、肯尼亚、40123 Kisumu
        • Investigational Site Number : 4040012
      • Mombasa、肯尼亚、80107 Ganjoni
        • Investigational Site Number : 4040008
      • Nairobi、肯尼亚、00100GPO
        • Investigational Site Number : 4040001
      • Nairobi、肯尼亚、00100
        • Investigational Site Number : 4040007
      • Thika、肯尼亚、00202 Kiambu
        • Investigational Site Number : 4040009

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

描述

纳入标准：

  • 纳入之日年满 18 岁或以上。
  • 对于人类免疫缺陷病毒 (HIV) 感染者，由目前服用抗逆转录病毒药物且 CD4 计数 > 200/mm3 的参与者确定的稳定 HIV 感染。
  • 在注册时进行的 SARS-CoV-2 快速血清诊断测试可检测 SARS-CoV-2 抗体的存在。
  • 不打算接受授权/批准的 COVID-19 疫苗，尽管研究者鼓励他们在注册时接受授权疫苗。
  • 已签署知情同意书并注明日期
  • 能够参加所有访问并遵守所有研究程序
  • 仅在当地、地区或国家法规要求时才享受健康保险

  • 如果女性参与者没有怀孕或哺乳，并且符合以下条件之一，则有资格参加：

    • 是没有生育能力的。 要被视为无生育潜力，女性必须绝经至少 1 年或手术绝育，或
    • 具有生育能力并同意在第一次研究干预给药前至少 4 周至第二次研究干预给药后至少 12 周使用有效的避孕方法或禁欲。

有生育能力的参与者必须在任何剂量的研究干预前 25 小时内进行高度敏感的妊娠试验（根据当地法规要求进行尿液或血清）阴性。

排除标准：

  • 已知对任何疫苗成分过敏，或对含有任何相同物质的疫苗有危及生命的反应史。
  • 痴呆症或任何其他认知状况可能会干扰遵循研究者的研究程序？ 判断。
  • 自我报告的血小板减少症，基于研究者的禁忌肌内 (IM) 疫苗接种？ 判断
  • 出血性疾病，或在入组前的过去 21 天内接受过抗凝剂，根据研究者的意见禁忌 IM 疫苗接种 判断。
  • 研究者或指定人员认为因参与而造成额外风险或可能干扰研究程序的不稳定的急性或慢性疾病。
  • 接种当天中度或重度急性疾病/感染（根据研究者的判断）或发热性疾病（温度？ 38.0℃[? 100.4华氏度]）。 在病情解决或发热事件消退之前，不应将预期参与者纳入研究。
  • 在第一次研究疫苗接种前 30 天或当天接种任何疫苗，或计划在第一次研究疫苗接种之间和第二次研究疫苗接种后 30 天内接种任何疫苗，流感疫苗除外，流感疫苗接种可在任何时间接种与研究干预相关的时间。
  • 先前接种过冠状病毒疫苗（SARS-CoV-2、SARS-CoV、中东呼吸综合征）。
  • 在过去 180 天内接受过实体器官或骨髓移植。
  • 最近 90 天内接受过抗癌化疗。
  • 被行政或法院命令剥夺自由，或在紧急情况下，或非自愿住院。
  • 被确定为直接参与拟议研究的研究者或研究者或研究中心的雇员，或被确定为直接参与拟议研究的研究者或雇员的直系亲属（即父母、配偶、亲生子女或领养子女）学习。
  • 在研究登记时（或在第一次研究疫苗接种前 30 天内）参与或计划在当前研究期间参与另一项调查疫苗、药物、医疗器械或医疗程序的临床研究。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：第一阶段：SARS-CoV-2 疫苗
在第 1 天和第 22 天注射 2 次单价 SARS-CoV-2 疫苗
生物：SARS-CoV-2 佐剂重组蛋白疫苗（单价 D614）（初级系列）
药物剂型：注射用乳剂。 给药途径：肌肉注射
生物：SARS-CoV-2 佐剂重组蛋白疫苗（单价 B.1.351）（加强剂量）>= 最后一次接种后 4 个月
药物剂型：注射用乳剂。 给药途径：肌肉注射。
安慰剂比较：第一阶段：安慰剂
在第 1 天和第 22 天注射 2 次安慰剂
生物：安慰剂
药物剂型：液体。 给药途径：肌肉注射。
生物：SARS-CoV-2 佐剂重组蛋白疫苗（单价 D614）（初级系列）& SARS-CoV-2 佐剂重组蛋白疫苗（单价 B.1.351）（加强剂）>=最后一次接种后 4 个月
药物剂型：注射用乳剂。 给药途径：肌肉注射。
实验性的：第 2 阶段：SARS-CoV-2 疫苗
在第 1 天和第 22 天注射 2 次二价 SARS-CoV-2 疫苗
生物：SARS-CoV-2 佐剂重组蛋白疫苗（单价 B.1.351）（加强剂量）>= 最后一次接种后 4 个月
药物剂型：注射用乳剂。 给药途径：肌肉注射。
生物：SARS-CoV-2 佐剂重组蛋白疫苗（二价 D614 + B.1.351）（初级系列）
药物剂型：注射用乳剂。 给药途径：肌肉注射。
安慰剂比较：第二阶段：安慰剂
在第 1 天和第 22 天注射 2 次安慰剂
生物：安慰剂
药物剂型：液体。 给药途径：肌肉注射。
生物：SARS-CoV-2 佐剂重组蛋白疫苗（单价 D614）（初级系列）& SARS-CoV-2 佐剂重组蛋白疫苗（单价 B.1.351）（加强剂）>=最后一次接种后 4 个月
药物剂型：注射用乳剂。 给药途径：肌肉注射。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Stage 1 and Stage 2: Number of Participants With Onset of Symptomatic Coronavirus Disease 2019 (COVID-19) Episode
大体时间：From Day 36 up to Day 387
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness (CLI).
From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Solicited Injection Site and Systemic Reactions
大体时间：Up to 7 days after each vaccination (post-dose on Days 1 and 22)
A solicited reaction was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form (CRF) collected within 7 days after each injection and considered to be related to the corresponding study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. Systemic AR were all ARs that were not injection site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the injection site.
Up to 7 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Unsolicited Non-Serious Adverse Events (AEs)
大体时间：Up to 21 days after each vaccination (post-dose on Days 1 and 22)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that was pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Up to 21 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Immediate Adverse Events
大体时间：Up to 30 minutes after each vaccination (post-dose on Days 1 and 22)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited injection site and systemic AEs which occurred within the first 30 minutes after vaccination.
Up to 30 minutes after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Medically Attended Adverse Events (MAAE), Serious Adverse Events (SAE), and Adverse Events of Special Interest (AESI)
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days
An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infection and/or Symptomatic COVID-19
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT) on at least 1 respiratory sample. This included positive results by any NAAT that included tests performed outside the trial protocol if confirmed by the adjudication committee. Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place. Here, percentage of participants with virologically-confirmed SARS-CoV-2 infection and/or symptomatic COVID-19 (regardless of adjudication) are reported.
From first dose of study vaccine administration (Day 1) up to 387 days

次要结果测量

结果测量
措施说明
大体时间
Stage 1 and Stage 2: Number of Participants With SARS-CoV-2 Infection
大体时间：From Day 36 up to Day 387
SARS-CoV-2 infection was defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection.
From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Occurrence of Severe COVID-19
大体时间：From Day 36 up to Day 387
Severe COVID-19 was defined as COVID-19 with any 1 of the following: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes. Supplemental oxygen administration for > 1 hour. Use of invasive or non-invasive ventilation or extracorporeal membrane oxygenation. Clinical diagnosis of respiratory failure. Significant acute renal, hepatic, or neurologic dysfunction. Shock. Admission to an intensive care unit. Death.
From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days
Asymptomatic SARS-CoV-2 infection was defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection was ascertained.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Swabs With Positive Nucleic Acid Amplification Test (NAAT)
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days

The viral copies were collected as protocol-defined respiratory swabs during participant's illness episode and reported as positive continuous values.

Here, duration between two consecutive positive NAAT results was calculated as: (the date of last swab tested positive) - (the date of first tested positive) + 1.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Respective Number of Days Between Two Consecutive Positive Nucleic Acid Amplification Test
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days
Duration between two consecutive positive NAAT results was calculated as: the date of last swab tested positive - the date of first swab tested positive + 1.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Positive NAAT for SARS-CoV-2
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by NAAT on at least 1 respiratory sample. Respiratory samples for NAAT testing were collected in participants with CLI through the study.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Centers for Disease Control and Prevention (CDC)-Defined COVID-19
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days
CDC-defined COVID-19 included virologically-confirmed SARS-CoV-2 infection with at least 1 of: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Occurrences of Hospitalized COVID-19
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days
Hospitalized COVID-19 was defined as an episode of symptomatic COVID-19 that required inpatient hospitalization.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Symptomatic COVID-19 With Severity of Moderate or Worse
大体时间：From first dose of study vaccine administration (Day 1) up to 387 days
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Moderate COVID-19 was defined as symptomatic COVID-19 with either shortness of breath that persisted for at least 12 hours or clinical signs of moderate illness measured at least on 2 occasions separated by 30 minutes and no clinical signs indicative of severe COVID-19.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, and 43
大体时间：Pre-vaccination on Day 1 and post-vaccination on Days 22, and 43
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 43
Crossover: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 43, 142, 163, and 322
大体时间：Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163 and 322
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163 and 322
Booster: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 22, and 202
大体时间：Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Stage 1 and Stage 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43
大体时间：Post-vaccination on Days 22 and 43
Responders are participants who had baseline values below lower limit of quantification (LLOQ) with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Post-vaccination on Days 22 and 43
Crossover: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322
大体时间：Post-vaccination on Days 43, 142, 163 and 322
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Post-vaccination on Days 43, 142, 163 and 322
Booster: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202
大体时间：Post-vaccination on Days 22, and 202
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Post-vaccination on Days 22, and 202
Stage 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43
大体时间：Pre-vaccination on Day 1 and post-vaccination on Days 22 and 43
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
Pre-vaccination on Day 1 and post-vaccination on Days 22 and 43
Crossover: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322
大体时间：Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163, and 322
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163, and 322
Booster: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202
大体时间：Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Number of Participants With Symptomatic COVID-19 Episodes
大体时间：Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Symptomatic COVID-19 is defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Grade 1: A type of AE that was usually transient and required only minimal treatment or therapeutic intervention and did not generally interfere with usual activities of daily living. Grade 2: A type of AE that was usually alleviated with additional therapeutic intervention and interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research participant. Grade 3: A type of AE that interrupted usual activities of daily living, or significantly affects clinical status, or required intensive therapeutic intervention.
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Number of Participants With COVID-19 Severity Using a 7-Point Ordinal Scale
大体时间：Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
The COVID-19 severity scale was based on the 7-point ordinal scale of clinical assessments: 1: death; 2: hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3: hospitalized, on non-invasive ventilation or high flow oxygen devices; 4: hospitalized, that required supplemental oxygen; 5: hospitalized, that did not require supplemental oxygen- discharged but required ongoing medical care (COVID-19 related or otherwise); 6: hospitalized, that did not require supplemental oxygen discharged without ongoing medical care; 7: not hospitalized.
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Number of Deaths Associated With COVID-19
大体时间：Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Death associated with COVID-19 was defined as death in a participant with COVID-19 who died within 28 days of the first positive specimen date or who died more than 28 days after the first specimen date and COVID-19 was mentioned as an immediate or underlying cause of death on the death certificate.
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sanofi Pasteur, a Sanofi Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月26日

初级完成 (实际的)

2024年8月31日

研究完成 (实际的)

2024年8月31日

研究注册日期

首次提交

2021年5月26日

首先提交符合 QC 标准的

2021年5月26日

首次发布 (实际的)

2021年5月27日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月6日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • VAT00008 (其他标识符：Sanofi Identifier)
  • U1111-1264-3238 (注册表标识符：ICTRP)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

合格的研究人员可以请求访问患者水平的数据和相关研究文件，包括临床研究报告、带有任何修订的研究方案、空白病例报告表、统计分析计划和数据集规范。 患者层面的数据将被匿名化，研究文件将被编辑以保护试验参与者的隐私。 有关赛诺菲数据共享标准、合格研究和请求访问流程的更多详细信息，请访问：https://vivli.org

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅