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. (NCT07779408) — USA Trial Details

Condition(s) studied

Healthy VolunteersInfluenza

Investigational drug(s) / intervention(s)

Flu H5 egg pandemic low dose vaccine, with adjuvantFlu H5 Egg Pandemic medium dose vaccine, with adjuvantFlu H5 Egg Pandemic high dose vaccine, with adjuvantFlu H5 Egg Pandemic high dose vaccine, without adjuvant

Flu H5 egg pandemic low dose vaccine, with adjuvant: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Flu H5 Egg Pandemic medium dose vaccine, with adjuvant: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Flu H5 Egg Pandemic high dose vaccine, with adjuvant: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Flu H5 Egg Pandemic high dose vaccine, without adjuvant: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Number of participants with immediate Adverse Events (AEs) — Within 30 minutes after each vaccination
Immediate adverse events are medically relevant unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants experiencing solicited administration site reactions (pre-listed in the participant diary and case report form [CRF]) — 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
Number of participants experiencing solicited systemic reactions (pre-listed in the participant diary and CRF) — Within 8 days of each vaccination, including the day of vaccination
All solicited reactions that are not solicited injection or administration site reactions
Number of participants experiencing unsolicited AEs — 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
Number of participants experiencing Medically Attended Adverse Events (MAAEs) — From Day 01 until the end of the study, approximately 14 months
MAAEs are collected throughout the study
Number of participants experiencing Adverse Events of Special Interest (AESIs) — From Day 01 until the end of the study, approximately 14 months
AESIs are collected throughout the study
Number of participants experiencing Serious Adverse Events (SAEs) — From Day 01 until the end of the study, approximately 14 months
SAEs are collected throughout the study
Number of participants experiencing out-of-range biological test results (including shift from baseline values) — Up to 8 days after each vaccination
Safety laboratory assessments will include clinical chemistry and hematology
Number of participants experiencing AEs leading to discontinuation — From Day 01 until the end of the study, approximately 14 months
AEs leading to discontinuation are collected throughout the study
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer — Day 01 and Day 43
Influenza vaccine antibody titers are measured by HAI assay
Number of participants with HAI Ab titer ≥ 40 (1 dilution [dil]; ie, seroprotection) — Day 43
Influenza vaccine antibody titers are measured by HAI assay
Number of participants with seroconversion — 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
Geometric mean titer ratio of individual HAI Ab titer ratio Day 43/Day 01 — Day 01 and Day 43
Influenza vaccine antibody titers are measured by HAI assay

Trial sites (16)

Facility	City	Region	Status
AMR Clinical Phoenix, Arizona- Site Number : 8400004	Tempe	Arizona	Recruiting
Peninsula Research Associates- Site Number : 8400011	Rolling Hills Estates	California	Recruiting
California Research Foundation- Site Number : 8400007	San Diego	California	Recruiting
Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003	Coral Gables	Florida	Recruiting
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017	DeLand	Florida	Recruiting
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001	Fort Myers	Florida	Recruiting
Indago Research & Health Center- Site Number : 8400010	Miami Lakes	Florida	Recruiting
Accel Research Sites - NeuroStudies- Site Number : 8400014	Decatur	Georgia	Recruiting
iResearch Atlanta- Site Number : 8400008	Decatur	Georgia	Recruiting
AMR Chicago- Site Number : 8400005	Oak Brook	Illinois	Recruiting
AMR Clinical Newton, Kansas- Site Number : 8400006	Newton	Kansas	Recruiting
Rochester Clinical Research- Site Number : 8400012	Rochester	New York	Recruiting
Coastal Carolina Research Center - North Charleston- Site Number : 8400018	North Charleston	South Carolina	Recruiting
Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002	Knoxville	Tennessee	Recruiting
CenExel JRB - Salth Lake City- Site Number : 8400009	Salt Lake City	Utah	Recruiting
Charlottesville Medical Research- Site Number : 8400016	Charlottesville	Virginia	Recruiting

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