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.
2026년 9월 11일 업데이트: 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).
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
640
단계
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Trial Transparency email recommended (Toll free for US & Canada)
- 전화번호: option 6 800-633-1610
- 이메일: contact-us@sanofi.com
연구 장소
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Arizona
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Tempe, Arizona, 미국, 85281
- 모병
- AMR Clinical Phoenix, Arizona- Site Number : 8400004
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California
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Rolling Hills Estates, California, 미국, 90274
- 모병
- Peninsula Research Associates- Site Number : 8400011
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San Diego, California, 미국, 92123
- 모병
- California Research Foundation- Site Number : 8400007
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Florida
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Coral Gables, Florida, 미국, 33134
- 모병
- Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
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DeLand, Florida, 미국, 32720
- 모병
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
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Fort Myers, Florida, 미국, 33912
- 모병
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
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Miami Lakes, Florida, 미국, 33016
- 모병
- Indago Research & Health Center- Site Number : 8400010
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Georgia
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Decatur, Georgia, 미국, 30030
- 모병
- Accel Research Sites - NeuroStudies- Site Number : 8400014
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Decatur, Georgia, 미국, 30030
- 모병
- iResearch Atlanta- Site Number : 8400008
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Illinois
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Oak Brook, Illinois, 미국, 60523
- 모병
- AMR Chicago- Site Number : 8400005
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Kansas
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Newton, Kansas, 미국, 67114
- 모병
- AMR Clinical Newton, Kansas- Site Number : 8400006
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New York
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Rochester, New York, 미국, 14609
- 모병
- Rochester Clinical Research- Site Number : 8400012
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South Carolina
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North Charleston, South Carolina, 미국, 29405
- 모병
- Coastal Carolina Research Center - North Charleston- Site Number : 8400018
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Tennessee
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Knoxville, Tennessee, 미국, 37909
- 모병
- Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
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Utah
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Salt Lake City, Utah, 미국, 84107
- 모병
- CenExel JRB - Salth Lake City- Site Number : 8400009
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Virginia
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Charlottesville, Virginia, 미국, 22911
- 모병
- Charlottesville Medical Research- Site Number : 8400016
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
4
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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
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Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
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실험적: 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
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Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
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실험적: 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
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Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
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실험적: 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
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Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of participants with immediate Adverse Events (AEs)
기간: Within 30 minutes after each vaccination
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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])
기간: Within 8 days of each vaccination, including the day of vaccination
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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
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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)
기간: 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
기간: 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)
기간: From Day 01 until the end of the study, approximately 14 months
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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)
기간: From Day 01 until the end of the study, approximately 14 months
|
AESIs 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 Serious Adverse Events (SAEs)
기간: From Day 01 until the end of the study, approximately 14 months
|
SAEs 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 out-of-range biological test results (including shift from baseline values)
기간: Up to 8 days after each vaccination
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Safety laboratory assessments will include clinical chemistry and hematology
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Up to 8 days after each vaccination
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Number of participants experiencing AEs leading to discontinuation
기간: From Day 01 until the end of the study, approximately 14 months
|
AEs leading to discontinuation are collected throughout the study
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From Day 01 until the end of the study, approximately 14 months
|
|
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer
기간: Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
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Day 01 and Day 43
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Number of participants with HAI Ab titer ≥ 40 (1 dilution [dil]; ie, seroprotection)
기간: Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 43
|
|
Number of participants with seroconversion
기간: 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
|
|
Geometric mean titer ratio of individual HAI Ab titer ratio Day 43/Day 01
기간: Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer obtained on Day 01, Day 22, Day 43, Day 202
기간: 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
기간: 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
|
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
기간: 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)
기간: 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
기간: 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
|
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Geometric mean titer of neutralization (NT) Ab titer
기간: Day 01, Day 22, Day 43, Day 202
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
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Day 01, Day 22, Day 43, Day 202
|
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Geometric mean titer ratio of individual NT Ab titer ratio
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: Day 43
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 43
|
|
Number of participants with detectable NT Ab titer
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 8월 3일
기본 완료 (추정된)
기본 완료
2028년 2월 22일
연구 완료 (추정된)
연구 완료
2028년 2월 22일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 31일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 19일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- VBX21138
- U1111-1325-2670 (레지스트리 식별자: ICTRP)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .