Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
2026年9月11日 更新者：Sanofi
A Phase 1/2, Parallel, Observer-blind Study to Assess the Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness.
The study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose).
Study duration per participant: approximately 14 months (including screening visit).
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
640
阶段
- 阶段2
- 阶段1
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。
学习联系方式
- 姓名：Trial Transparency email recommended (Toll free for US & Canada)
- 电话号码：option 6 800-633-1610
- 邮箱：contact-us@sanofi.com
学习地点
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Arizona
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Tempe、Arizona、美国、85281
- 招聘中
- AMR Clinical Phoenix, Arizona- Site Number : 8400004
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California
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Rolling Hills Estates、California、美国、90274
- 招聘中
- Peninsula Research Associates- Site Number : 8400011
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San Diego、California、美国、92123
- 招聘中
- California Research Foundation- Site Number : 8400007
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Florida
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Coral Gables、Florida、美国、33134
- 招聘中
- Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
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DeLand、Florida、美国、32720
- 招聘中
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
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Fort Myers、Florida、美国、33912
- 招聘中
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
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Miami Lakes、Florida、美国、33016
- 招聘中
- Indago Research & Health Center- Site Number : 8400010
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Georgia
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Decatur、Georgia、美国、30030
- 招聘中
- Accel Research Sites - NeuroStudies- Site Number : 8400014
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Decatur、Georgia、美国、30030
- 招聘中
- iResearch Atlanta- Site Number : 8400008
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Illinois
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Oak Brook、Illinois、美国、60523
- 招聘中
- AMR Chicago- Site Number : 8400005
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Kansas
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Newton、Kansas、美国、67114
- 招聘中
- AMR Clinical Newton, Kansas- Site Number : 8400006
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New York
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Rochester、New York、美国、14609
- 招聘中
- Rochester Clinical Research- Site Number : 8400012
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South Carolina
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North Charleston、South Carolina、美国、29405
- 招聘中
- Coastal Carolina Research Center - North Charleston- Site Number : 8400018
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Tennessee
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Knoxville、Tennessee、美国、37909
- 招聘中
- Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
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Utah
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Salt Lake City、Utah、美国、84107
- 招聘中
- CenExel JRB - Salth Lake City- Site Number : 8400009
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Virginia
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Charlottesville、Virginia、美国、22911
- 招聘中
- Charlottesville Medical Research- Site Number : 8400016
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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
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Aged 18 years or above on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history
- Not pregnant/breastfeeding; non-childbearing potential or uses effective contraception/abstinence from ≥4 weeks before the first study intervention dose to ≥8 weeks after the last dose
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all study procedures
- Covered by health insurance, if required by local regulations
Exclusion Criteria:
- Known or suspected immunodeficiency; immunosuppressive therapy in past 6 months; or long-term systemic corticosteroid (eg, prednisone for more than 2 weeks in the past 3 months)
- Known hepatitis B or hepatitis C infection (based on medical history)
- Known personal or family history of previous episodes of Guillan-Barré syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
- Known systemic hypersensitivity to any of the study intervention components or history of life-threatening reaction to the study interventions or products with same substances
- Self-reported thrombocytopenia contraindicating intramuscular (IM) injection based on investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection based on investigator's judgment
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- History of A/H5 infection prior to the study participation
- Moderate or severe acute illness/infection (per investigator judgment)/fever (≥ 38.0°C [≥ 100.4°F]) on study intervention day. Include participant only after the condition or fever has resolved
- Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
- Any vaccine given 4 weeks before first study intervention or any planned vaccination to be given prior to Day 43 (ie, approximately 21 days after the second study intervention)
- Previous vaccination against A(H5) with an investigational or marketed vaccine. This includes, but is not limited to, influenza subtypes A(H5N1), A(H5N8), and A(H5N6)
- Has received a blood transfusion or blood-derived products, including immunoglobulins in the past 3 months
- Participation in another clinical study for a vaccine, drug, medical device, or medical procedure within 4 weeks before enrollment or planned participation during the present study period
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Is an investigator, investigator/study center employee, or immediate family member (parent, spouse, natural/adopted child) of the investigator/employee with direct involvement in the study
- Any screening safety laboratory parameters out of normal ranges and assessed as > Grade 2
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1: Flu H5 egg pandemic low dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic low dose vaccine, with adjuvant
|
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
|
实验性的：Group 2: Flu H5 Egg Pandemic medium dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic medium dose vaccine, with adjuvant
|
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
|
实验性的：Group 3: Flu H5 Egg Pandemic high dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, with adjuvant
|
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
|
实验性的：Group 4: Flu H5 Egg Pandemic high dose vaccine, without adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, without adjuvant
|
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
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 |
|---|---|---|
|
Number of participants with immediate Adverse Events (AEs)
大体时间：Within 30 minutes after each vaccination
|
Immediate adverse events are medically relevant unsolicited systemic adverse events reported in the 30 minutes after vaccination
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Within 30 minutes after each vaccination
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Number of participants experiencing solicited administration site reactions (pre-listed in the participant diary and case report form [CRF])
大体时间：Within 8 days of each vaccination, including the day of vaccination
|
A solicited reaction is an adverse reaction (sign or symptom) observed and reported under the conditions pre-listed (for example: injection site pain or headache).
Solicited administration site reactions are reactions at and around the injection/administration site
|
Within 8 days of each vaccination, including the day of vaccination
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|
Number of participants experiencing solicited systemic reactions (pre-listed in the participant diary and CRF)
大体时间：Within 8 days of each vaccination, including the day of vaccination
|
All solicited reactions that are not solicited injection or administration site reactions
|
Within 8 days of each vaccination, including the day of vaccination
|
|
Number of participants experiencing unsolicited AEs
大体时间：Within 21 days after the first vaccination, including the day of the first vaccination, and within 28 days after the second vaccination, including the day of the second vaccination
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Unsolicited AE: an observed AE that does not fulfill the conditions of solicited reactions
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Within 21 days after the first vaccination, including the day of the first vaccination, and within 28 days after the second vaccination, including the day of the second vaccination
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Number of participants experiencing Medically Attended Adverse Events (MAAEs)
大体时间：From Day 01 until the end of the study, approximately 14 months
|
MAAEs are collected throughout the study
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From Day 01 until the end of the study, approximately 14 months
|
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Number of participants experiencing Adverse Events of Special Interest (AESIs)
大体时间：From Day 01 until the end of the study, approximately 14 months
|
AESIs are collected throughout the study
|
From Day 01 until the end of the study, approximately 14 months
|
|
Number of participants experiencing Serious Adverse Events (SAEs)
大体时间：From Day 01 until the end of the study, approximately 14 months
|
SAEs are collected throughout the study
|
From Day 01 until the end of the study, approximately 14 months
|
|
Number of participants experiencing out-of-range biological test results (including shift from baseline values)
大体时间：Up to 8 days after each vaccination
|
Safety laboratory assessments will include clinical chemistry and hematology
|
Up to 8 days after each vaccination
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Number of participants experiencing AEs leading to discontinuation
大体时间：From Day 01 until the end of the study, approximately 14 months
|
AEs leading to discontinuation are collected throughout the study
|
From Day 01 until the end of the study, approximately 14 months
|
|
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer
大体时间：Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
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Number of participants with HAI Ab titer ≥ 40 (1 dilution [dil]; ie, seroprotection)
大体时间：Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 43
|
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Number of participants with seroconversion
大体时间：Day 01 and Day 43
|
Seroconversion is defined as HAI Ab titer < 10 (1/dil) on Day 01 and post-injection titer ≥ 40 (1/dil) on Day 43; or defined as HAI Ab titer ≥ 10 (1/dil) on Day 01 and a ≥ 4-fold increase in titer (1/dil) on Day 43
|
Day 01 and Day 43
|
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Geometric mean titer ratio of individual HAI Ab titer ratio Day 43/Day 01
大体时间：Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer obtained on Day 01, Day 22, Day 43, Day 202
大体时间：Day 01, Day 22, Day 43, Day 202
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01, Day 22, Day 43, Day 202
|
|
Geometric mean titer ratio of individual HAI Ab titer ratios Day 22/Day 01, Day 43/Day 01, Day 202/Day 43
大体时间：Day 01, Day 22, Day 43, Day 202
|
Individual HAI Ab titer ratios are calculated for the following time points: Day 22/Day 01, Day 43/Day 01 and Day 202/Day 43
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Day 01, Day 22, Day 43, Day 202
|
|
Number of participants with individual HAI Ab titer ≥ 40 (1/dil) on Day 01, Day 22, Day 43, Day 202
大体时间：Day 01, Day 22, Day 43, Day 202
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01, Day 22, Day 43, Day 202
|
|
Number of participants with seroconversion on Day 22 compared to Day 01 (baseline)
大体时间：Day 01, Day 22
|
Seroconversion is defined as titer < 10 (1/dil) on Day 01 and post-injection titer ≥ 40 (1/dil) on Day 22; or defined as titer ≥ 10 (1/dil) on Day 01 and a ≥ 4 fold increase in titer (1/dil) on Day 22
|
Day 01, Day 22
|
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Number of participants with detectable HAI Ab titer
大体时间：Day 01, Day 22, Day 43, Day 202
|
Detectable HAI Ab titer: a titer ≥ 10 (1/dil)
|
Day 01, Day 22, Day 43, Day 202
|
|
Geometric mean titer of neutralization (NT) Ab titer
大体时间：Day 01, Day 22, Day 43, Day 202
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 01, Day 22, Day 43, Day 202
|
|
Geometric mean titer ratio of individual NT Ab titer ratio
大体时间：Day 01, Day 22, Day 43, Day 202
|
Individual NT Ab titer ratios are calculated for the following time points: Day 22/Day 01, Day 43/Day 01 and Day 202/Day 43
|
Day 01, Day 22, Day 43, Day 202
|
|
Number of participants with NT Ab titer ≥ 20 (1/dil)
大体时间：Day 01, Day 43, Day 202
|
NT Ab titer ≥ 20 (1/dil) on Day 43; compared to Day 01 and Day 202
|
Day 01, Day 43, Day 202
|
|
Number of participants with NT Ab titer ≥ 40 (1/dil)
大体时间：Day 01, Day 43, Day 202
|
NT Ab titer ≥ 40 (1/dil) on Day 43; compared to Day 01 and Day 202
|
Day 01, Day 43, Day 202
|
|
Number of participants with NT Ab titer ≥ 80 (1/dil)
大体时间：Day 01, Day 43, Day 202
|
NT Ab titer ≥ 80 (1/dil) on Day 43; compared to Day 01 and Day 202
|
Day 01, Day 43, Day 202
|
|
Geometric mean fold-rise of fold increase in NT Ab titer [post/pre] ≥ 2 and ≥ 4
大体时间：Day 43
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 43
|
|
Number of participants with detectable NT Ab titer
大体时间：Day 01, Day 22, Day 43, Day 202
|
Detectable NT Ab titer: a titer ≥ 10 (1/dil) on Day 01, Day 22, Day 43, Day 202
|
Day 01, Day 22, Day 43, Day 202
|
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
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)
2026年8月3日
初级完成 (估计的)
2028年2月22日
研究完成 (估计的)
2028年2月22日
研究注册日期
首次提交
2026年7月31日
首先提交符合 QC 标准的
2026年8月19日
首次发布 (实际的)
2026年8月21日
研究记录更新
最后更新发布 (实际的)
2026年9月15日
上次提交的符合 QC 标准的更新
2026年9月11日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- VBX21138
- U1111-1325-2670 (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
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: 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
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.