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 septembre 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
640
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Trial Transparency email recommended (Toll free for US & Canada)
- Numéro de téléphone: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Lieux d'étude
-
-
Arizona
-
Tempe, Arizona, États-Unis, 85281
- Recrutement
- AMR Clinical Phoenix, Arizona- Site Number : 8400004
-
-
California
-
Rolling Hills Estates, California, États-Unis, 90274
- Recrutement
- Peninsula Research Associates- Site Number : 8400011
-
San Diego, California, États-Unis, 92123
- Recrutement
- California Research Foundation- Site Number : 8400007
-
-
Florida
-
Coral Gables, Florida, États-Unis, 33134
- Recrutement
- Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
-
DeLand, Florida, États-Unis, 32720
- Recrutement
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
-
Fort Myers, Florida, États-Unis, 33912
- Recrutement
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
-
Miami Lakes, Florida, États-Unis, 33016
- Recrutement
- Indago Research & Health Center- Site Number : 8400010
-
-
Georgia
-
Decatur, Georgia, États-Unis, 30030
- Recrutement
- Accel Research Sites - NeuroStudies- Site Number : 8400014
-
Decatur, Georgia, États-Unis, 30030
- Recrutement
- iResearch Atlanta- Site Number : 8400008
-
-
Illinois
-
Oak Brook, Illinois, États-Unis, 60523
- Recrutement
- AMR Chicago- Site Number : 8400005
-
-
Kansas
-
Newton, Kansas, États-Unis, 67114
- Recrutement
- AMR Clinical Newton, Kansas- Site Number : 8400006
-
-
New York
-
Rochester, New York, États-Unis, 14609
- Recrutement
- Rochester Clinical Research- Site Number : 8400012
-
-
South Carolina
-
North Charleston, South Carolina, États-Unis, 29405
- Recrutement
- Coastal Carolina Research Center - North Charleston- Site Number : 8400018
-
-
Tennessee
-
Knoxville, Tennessee, États-Unis, 37909
- Recrutement
- Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
-
-
Utah
-
Salt Lake City, Utah, États-Unis, 84107
- Recrutement
- CenExel JRB - Salth Lake City- Site Number : 8400009
-
-
Virginia
-
Charlottesville, Virginia, États-Unis, 22911
- Recrutement
- Charlottesville Medical Research- Site Number : 8400016
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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)
|
|
Expérimental: 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)
|
|
Expérimental: 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)
|
|
Expérimental: 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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants with immediate Adverse Events (AEs)
Délai: 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])
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 43
|
|
Number of participants with seroconversion
Délai: 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
Délai: Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer obtained on Day 01, Day 22, Day 43, Day 202
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: Day 43
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 43
|
|
Number of participants with detectable NT Ab titer
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
3 août 2026
Achèvement primaire (Estimé)
22 février 2028
Achèvement de l'étude (Estimé)
22 février 2028
Dates d'inscription aux études
Première soumission
31 juillet 2026
Première soumission répondant aux critères de contrôle qualité
19 août 2026
Première publication (Réel)
21 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- VBX21138
- U1111-1325-2670 (Identificateur de registre: ICTRP)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .