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 de septiembre de 2026 actualizado por: 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).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
640
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Trial Transparency email recommended (Toll free for US & Canada)
- Número de teléfono: option 6 800-633-1610
- Correo electrónico: contact-us@sanofi.com
Ubicaciones de estudio
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Arizona
-
Tempe, Arizona, Estados Unidos, 85281
- Reclutamiento
- AMR Clinical Phoenix, Arizona- Site Number : 8400004
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California
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Rolling Hills Estates, California, Estados Unidos, 90274
- Reclutamiento
- Peninsula Research Associates- Site Number : 8400011
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San Diego, California, Estados Unidos, 92123
- Reclutamiento
- California Research Foundation- Site Number : 8400007
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Florida
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Coral Gables, Florida, Estados Unidos, 33134
- Reclutamiento
- Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
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DeLand, Florida, Estados Unidos, 32720
- Reclutamiento
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
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Fort Myers, Florida, Estados Unidos, 33912
- Reclutamiento
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
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Miami Lakes, Florida, Estados Unidos, 33016
- Reclutamiento
- Indago Research & Health Center- Site Number : 8400010
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Georgia
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Decatur, Georgia, Estados Unidos, 30030
- Reclutamiento
- Accel Research Sites - NeuroStudies- Site Number : 8400014
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Decatur, Georgia, Estados Unidos, 30030
- Reclutamiento
- iResearch Atlanta- Site Number : 8400008
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Illinois
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Oak Brook, Illinois, Estados Unidos, 60523
- Reclutamiento
- AMR Chicago- Site Number : 8400005
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Kansas
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Newton, Kansas, Estados Unidos, 67114
- Reclutamiento
- AMR Clinical Newton, Kansas- Site Number : 8400006
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New York
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Rochester, New York, Estados Unidos, 14609
- Reclutamiento
- Rochester Clinical Research- Site Number : 8400012
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South Carolina
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North Charleston, South Carolina, Estados Unidos, 29405
- Reclutamiento
- Coastal Carolina Research Center - North Charleston- Site Number : 8400018
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37909
- Reclutamiento
- Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
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Utah
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Salt Lake City, Utah, Estados Unidos, 84107
- Reclutamiento
- CenExel JRB - Salth Lake City- Site Number : 8400009
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22911
- Reclutamiento
- Charlottesville Medical Research- Site Number : 8400016
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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)
|
|
Experimental: 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)
|
|
Experimental: 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)
|
|
Experimental: 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)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with immediate Adverse Events (AEs)
Periodo de tiempo: 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])
Periodo de tiempo: 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
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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)
Periodo de tiempo: Within 8 days of each vaccination, including the day of vaccination
|
All solicited reactions that are not solicited injection or administration site reactions
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Within 8 days of each vaccination, including the day of vaccination
|
|
Number of participants experiencing unsolicited AEs
Periodo de tiempo: 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
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: From Day 01 until the end of the study, approximately 14 months
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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
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Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer
Periodo de tiempo: Day 01 and Day 43
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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)
Periodo de tiempo: Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
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Day 43
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Number of participants with seroconversion
Periodo de tiempo: Day 01 and Day 43
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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
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Day 01 and Day 43
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Geometric mean titer ratio of individual HAI Ab titer ratio Day 43/Day 01
Periodo de tiempo: Day 01 and Day 43
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Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer obtained on Day 01, Day 22, Day 43, Day 202
Periodo de tiempo: 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
|
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Geometric mean titer ratio of individual HAI Ab titer ratios Day 22/Day 01, Day 43/Day 01, Day 202/Day 43
Periodo de tiempo: Day 01, Day 22, Day 43, Day 202
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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
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Number of participants with individual HAI Ab titer ≥ 40 (1/dil) on Day 01, Day 22, Day 43, Day 202
Periodo de tiempo: 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)
Periodo de tiempo: 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
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Day 01, Day 22
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Number of participants with detectable HAI Ab titer
Periodo de tiempo: Day 01, Day 22, Day 43, Day 202
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Detectable HAI Ab titer: a titer ≥ 10 (1/dil)
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Day 01, Day 22, Day 43, Day 202
|
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Geometric mean titer of neutralization (NT) Ab titer
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Number of participants with NT Ab titer ≥ 20 (1/dil)
Periodo de tiempo: Day 01, Day 43, Day 202
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
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Geometric mean fold-rise of fold increase in NT Ab titer [post/pre] ≥ 2 and ≥ 4
Periodo de tiempo: Day 43
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 43
|
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Number of participants with detectable NT Ab titer
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de agosto de 2026
Finalización primaria (Estimado)
22 de febrero de 2028
Finalización del estudio (Estimado)
22 de febrero de 2028
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de agosto de 2026
Publicado por primera vez (Actual)
21 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VBX21138
- U1111-1325-2670 (Identificador de registro: ICTRP)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .