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 września 2026 zaktualizowane przez: 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).
Przegląd badań
Status
Rekrutacyjny
Warunki
Typ studiów
Interwencyjne
Zapisy (Szacowany)
640
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Trial Transparency email recommended (Toll free for US & Canada)
- Numer telefonu: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Lokalizacje studiów
-
-
Arizona
-
Tempe, Arizona, Stany Zjednoczone, 85281
- Rekrutacyjny
- AMR Clinical Phoenix, Arizona- Site Number : 8400004
-
-
California
-
Rolling Hills Estates, California, Stany Zjednoczone, 90274
- Rekrutacyjny
- Peninsula Research Associates- Site Number : 8400011
-
San Diego, California, Stany Zjednoczone, 92123
- Rekrutacyjny
- California Research Foundation- Site Number : 8400007
-
-
Florida
-
Coral Gables, Florida, Stany Zjednoczone, 33134
- Rekrutacyjny
- Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
-
DeLand, Florida, Stany Zjednoczone, 32720
- Rekrutacyjny
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
-
Fort Myers, Florida, Stany Zjednoczone, 33912
- Rekrutacyjny
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
-
Miami Lakes, Florida, Stany Zjednoczone, 33016
- Rekrutacyjny
- Indago Research & Health Center- Site Number : 8400010
-
-
Georgia
-
Decatur, Georgia, Stany Zjednoczone, 30030
- Rekrutacyjny
- Accel Research Sites - NeuroStudies- Site Number : 8400014
-
Decatur, Georgia, Stany Zjednoczone, 30030
- Rekrutacyjny
- iResearch Atlanta- Site Number : 8400008
-
-
Illinois
-
Oak Brook, Illinois, Stany Zjednoczone, 60523
- Rekrutacyjny
- AMR Chicago- Site Number : 8400005
-
-
Kansas
-
Newton, Kansas, Stany Zjednoczone, 67114
- Rekrutacyjny
- AMR Clinical Newton, Kansas- Site Number : 8400006
-
-
New York
-
Rochester, New York, Stany Zjednoczone, 14609
- Rekrutacyjny
- Rochester Clinical Research- Site Number : 8400012
-
-
South Carolina
-
North Charleston, South Carolina, Stany Zjednoczone, 29405
- Rekrutacyjny
- Coastal Carolina Research Center - North Charleston- Site Number : 8400018
-
-
Tennessee
-
Knoxville, Tennessee, Stany Zjednoczone, 37909
- Rekrutacyjny
- Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
-
-
Utah
-
Salt Lake City, Utah, Stany Zjednoczone, 84107
- Rekrutacyjny
- CenExel JRB - Salth Lake City- Site Number : 8400009
-
-
Virginia
-
Charlottesville, Virginia, Stany Zjednoczone, 22911
- Rekrutacyjny
- Charlottesville Medical Research- Site Number : 8400016
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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)
|
|
Eksperymentalny: 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)
|
|
Eksperymentalny: 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)
|
|
Eksperymentalny: 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)
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of participants with immediate Adverse Events (AEs)
Ramy czasowe: 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
|
|
Number of participants experiencing solicited administration site reactions (pre-listed in the participant diary and case report form [CRF])
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 43
|
|
Number of participants with seroconversion
Ramy czasowe: 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
Ramy czasowe: Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer obtained on Day 01, Day 22, Day 43, Day 202
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Day 43
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 43
|
|
Number of participants with detectable NT Ab titer
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
3 sierpnia 2026
Zakończenie podstawowe (Szacowany)
22 lutego 2028
Ukończenie studiów (Szacowany)
22 lutego 2028
Daty rejestracji na studia
Pierwszy przesłany
31 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
21 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
15 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- VBX21138
- U1111-1325-2670 (Identyfikator rejestru: ICTRP)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .