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.
11. september 2026 opdateret af: 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).
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
640
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Studiesteder
-
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Arizona
-
Tempe, Arizona, Forenede Stater, 85281
- Rekruttering
- AMR Clinical Phoenix, Arizona- Site Number : 8400004
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California
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Rolling Hills Estates, California, Forenede Stater, 90274
- Rekruttering
- Peninsula Research Associates- Site Number : 8400011
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San Diego, California, Forenede Stater, 92123
- Rekruttering
- California Research Foundation- Site Number : 8400007
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Florida
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Coral Gables, Florida, Forenede Stater, 33134
- Rekruttering
- Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
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DeLand, Florida, Forenede Stater, 32720
- Rekruttering
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
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Fort Myers, Florida, Forenede Stater, 33912
- Rekruttering
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
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Miami Lakes, Florida, Forenede Stater, 33016
- Rekruttering
- Indago Research & Health Center- Site Number : 8400010
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Georgia
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Decatur, Georgia, Forenede Stater, 30030
- Rekruttering
- Accel Research Sites - NeuroStudies- Site Number : 8400014
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Decatur, Georgia, Forenede Stater, 30030
- Rekruttering
- iResearch Atlanta- Site Number : 8400008
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Illinois
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Oak Brook, Illinois, Forenede Stater, 60523
- Rekruttering
- AMR Chicago- Site Number : 8400005
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Kansas
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Newton, Kansas, Forenede Stater, 67114
- Rekruttering
- AMR Clinical Newton, Kansas- Site Number : 8400006
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New York
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Rochester, New York, Forenede Stater, 14609
- Rekruttering
- Rochester Clinical Research- Site Number : 8400012
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South Carolina
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North Charleston, South Carolina, Forenede Stater, 29405
- Rekruttering
- Coastal Carolina Research Center - North Charleston- Site Number : 8400018
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37909
- Rekruttering
- Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Rekruttering
- CenExel JRB - Salth Lake City- Site Number : 8400009
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22911
- Rekruttering
- Charlottesville Medical Research- Site Number : 8400016
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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)
|
|
Eksperimentel: 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)
|
|
Eksperimentel: 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)
|
|
Eksperimentel: 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)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with immediate Adverse Events (AEs)
Tidsramme: Within 30 minutes after each vaccination
|
Immediate adverse events are medically relevant unsolicited systemic adverse events reported in the 30 minutes after vaccination
|
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])
Tidsramme: 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
|
|
Number of participants experiencing solicited systemic reactions (pre-listed in the participant diary and CRF)
Tidsramme: 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
Tidsramme: 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
|
Unsolicited AE: an observed AE that does not fulfill the conditions of solicited reactions
|
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
|
|
Number of participants experiencing Medically Attended Adverse Events (MAAEs)
Tidsramme: From Day 01 until the end of the study, approximately 14 months
|
MAAEs are collected throughout the study
|
From Day 01 until the end of the study, approximately 14 months
|
|
Number of participants experiencing Adverse Events of Special Interest (AESIs)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to 8 days after each vaccination
|
Safety laboratory assessments will include clinical chemistry and hematology
|
Up to 8 days after each vaccination
|
|
Number of participants experiencing AEs leading to discontinuation
Tidsramme: 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
Tidsramme: Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
|
Number of participants with HAI Ab titer ≥ 40 (1 dilution [dil]; ie, seroprotection)
Tidsramme: Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 43
|
|
Number of participants with seroconversion
Tidsramme: 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
Tidsramme: Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer obtained on Day 01, Day 22, Day 43, Day 202
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
|
Number of participants with detectable HAI Ab titer
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Day 43
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 43
|
|
Number of participants with detectable NT Ab titer
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. august 2026
Primær færdiggørelse (Anslået)
22. februar 2028
Studieafslutning (Anslået)
22. februar 2028
Datoer for studieregistrering
Først indsendt
31. juli 2026
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VBX21138
- U1111-1325-2670 (Registry Identifier: ICTRP)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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