INFLUENZA A/ASTRAKHAN/3212/2020 (H5N8)-LIKE STRAIN (CBER-RG8A) (CLADE 2.3.4.4B) for Influenza A (H5N8) | Influenza A (H5N1)

Inclusion criteria

• {"criterion_text":"- Participant must be 35 to 70 years of age inclusive, at the time of study intervention."}
• {"criterion_text":"- Participants who are overtly healthy as determined by medical evaluation"}
• {"criterion_text":"- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. report adverse events, return for follow-up visits)."}
• {"criterion_text":"- Participants who are medically stable in the opinion of the investigator at the time of the study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable and without potential influence on the immune response as to the opinion of the investigator."}
• {"criterion_text":"- Body Mass Index within the range 18.0 to 35.0 kg/m 2 (inclusive)"}
• {"criterion_text":"- Female participants of non-childbearing potential may be enrolled in the study. Non- childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause*.   *A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy."}
• {"criterion_text":"- Female participants of childbearing potential may be enrolled in the study if the participant meets both of the following criteria: a. has practiced adequate contraception from 1 month prior to study intervention administration and agreed to continue adequate contraception until the end of the study. b. is not pregnant at the day of the study intervention administration, as per the medical anamnesis and urine pregnancy test."}
• {"criterion_text":"- Capable of giving signed informed consent prior to performance of any study-specific procedure, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol."}
• {"criterion_text":"- For H5N1 primed participants, vaccination with PanFluVac H5N1 Matrix M adjuvanted vaccine in Phase I study in 2009."}

Exclusion criteria

• {"criterion_text":"- History of any reaction or hypersensitivity likely to be exacerbated by egg, chicken protein, ovalbumin, formaldehyde, hydrocortisone, kanamycin, neomycin sulphate, cetyltrimethylammonium bromide (CTAB), any component of the study intervention including a known history of severe allergic reaction (e.g., anaphylaxis)."}
• {"criterion_text":"- Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the administration of the study intervention and ending at the completion of the study."}
• {"criterion_text":"- Planned administration of a vaccine in the period starting 30 days before the study intervention administration and ending at day 56. If the study takes place in the autumn or winter seasonal influenza vaccine will be offered after day 56 samples."}
• {"criterion_text":"- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the completion of the study.  a. Up to 3 months prior to the study intervention administration:   i. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled and topical steroids are allowed.  ii. Administration of immunoglobulins and/or any blood products or plasma derivatives.  b. Up to 6 months prior to the study intervention administration: long-acting immune-modifying drugs including among other immunotherapy (e.g., TNF- inhibitors), monoclonal antibodies and antitumoral medication."}
• {"criterion_text":"- Concurently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device)."}
• {"criterion_text":"- Pregnant or lactating female participant."}
• {"criterion_text":"- Female participant planning to become pregnant or planning to discontinue contraceptive precautions."}
• {"criterion_text":"- History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures."}
• {"criterion_text":"- Body Mass Index < 18.0 or > 35.0kg/m2"}
• {"criterion_text":"- Presence of a tattoo on the study intervention administration site that would prevent the assessment of the occurrence of local adverse events."}
• {"criterion_text":"- Any confirmed or suspected immunosuppressive condition, resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory required)."}
• {"criterion_text":"- Recurrent history of uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol."}
• {"criterion_text":"- Serious or unstable chronic illness"}
• {"criterion_text":"- Any history of dementia or any medical condition that moderately or severely impairs cognition."}
• {"criterion_text":"- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study or impact the immune response such as autoimmune diseases."}
• {"criterion_text":"- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe."}
• {"criterion_text":"- Any SAE attributed to a previous dose of an influenza vaccine."}
• {"criterion_text":"- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study."}

Primary endpoints

• {"endpoint_text":"- Serum haemagglutination inhibition (HI) antibody titres against the vaccine virus strain (H5N8 clade 2.3.4.4b) at baseline (Day 0) and 28 days after the first dose, and 28 days after the second dose (Day 56).","definition_or_measurement_approach":"Measurement of serum haemagglutination inhibition (HI) antibody titres against the vaccine virus strain at specified timepoints: baseline (Day 0), 28 days after first dose (Day 28), and 28 days after second dose (Day 56)."}
• {"endpoint_text":"- Serum microneutralisation (MN) antibody titres against the vaccine virus strain (H5N8 clade 2.3.4.4b) at baseline (Day 0), 28 days after the first dose, and 28 days after the second dose (Day 56)","definition_or_measurement_approach":"Measurement of serum microneutralisation (MN) antibody titres against the vaccine virus strain at baseline (Day 0), 28 days after first dose (Day 28), and 28 days after second dose (Day 56)."}

Secondary endpoints

• {"endpoint_text":"- Serum HI antibody titres against the vaccine virus strain (H5N8 clade 2.3.4.4b) 7 days after the first dose, 7 days after the second dose (Day 35)","definition_or_measurement_approach":"Measurement of serum HI antibody titres at Day 7 after first dose and Day 35 (7 days after second dose)."}
• {"endpoint_text":"- Fold increase in serum HI antibody titres against the virus strain (H5N8 clade 2.3.4.4b) 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56), compared to baseline (Day 0)","definition_or_measurement_approach":"Fold-rise calculations comparing serum HI titres at Day 7 and Day 28 after first dose, and Day 7 and Day 28 after second dose, versus baseline (Day 0)."}
• {"endpoint_text":"- Serodetection, based on serum HI antibody titres against the virus strain (H5N8 clade 2.3.4.4b) at baseline (Day 0), 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56)","definition_or_measurement_approach":"Assessment of serodetection status based on HI titres at listed timepoints."}
• {"endpoint_text":"- Seroconversion, based on serum HI antibody titres against the virus strain (H5N8 clade 2.3.4.4b) 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56), compared to baseline (Day 0)","definition_or_measurement_approach":"Determination of seroconversion based on predefined increases in HI titres compared to baseline at specified timepoints."}
• {"endpoint_text":"- Seroprotection, based on serum HI antibody titres against the virus strain (H5N8 clade 2.3.4.4b) at baseline (Day 0), 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56)","definition_or_measurement_approach":"Assessment of seroprotection rates based on HI titre thresholds at listed timepoints."}
• {"endpoint_text":"- Serum MN antibody titres against the vaccine virus strain (H5N8 clade 2.3.4.4b) 7 days after the first dose, and 7 days after the second dose (Day 35)","definition_or_measurement_approach":"Measurement of serum microneutralisation (MN) antibody titres at Day 7 after first dose and Day 35 (7 days after second dose)."}
• {"endpoint_text":"- Serum HI antibody titres against heterologous variant virus strains (including H5N1 clade 1 A/Vietnam/1194/2004 and H5N1 clade 2.2.1 A/turkey/Turkey/1/2005) at baseline (Day 0), 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56)","definition_or_measurement_approach":"Measurement of HI antibody titres against specified heterologous strains at listed timepoints."}
• {"endpoint_text":"- Fold increase in serum HI antibody titres against heterologous virus strains (including H5N1 clade 1 A/Vietnam/1194/2004 and H5N1 clade 2.2.1 A/turkey/Turkey/1/2005) 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 56), compared to baseline (Day 0)","definition_or_measurement_approach":"Fold-rise calculations for HI titres against heterologous strains at specified timepoints versus baseline."}
• {"endpoint_text":"- Serodetection, based on serum HI antibody titres against heterologous virus strains (H5N1 clade 1 A/Vietnam/1194/2004 and H5N1 clade 2.2.1 A/turkey/Turkey/1/2005) at baseline (Day 0), 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56)","definition_or_measurement_approach":"Assessment of serodetection for heterologous strains at listed timepoints based on HI titres."}
• {"endpoint_text":"- Seroconversion, based on serum HI antibody titres against heterologous virus strains (including to H5N1 clade 1 A/Vietnam/1194/2004 and H5N1 clade 2.2.1 A/turkey/Turkey/1/2005) 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56), compared to baseline (Day 0)","definition_or_measurement_approach":"Determination of seroconversion for heterologous strains based on changes in HI titres versus baseline at specified timepoints."}
• {"endpoint_text":"- Seroprotection, based on serum HI antibody titres against heterologous virus strains (including to H5N1 clade 1 A/Vietnam/1194/2004 and H5N1 clade 2.2.1 A/turkey/Turkey/1/2005) at baseline (Day 0), 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56)","definition_or_measurement_approach":"Assessment of seroprotection for heterologous strains at listed timepoints based on HI titre thresholds."}
• {"endpoint_text":"- Serum MN antibody titres against heterologous virus strains (including H5N1 clade 1 A/Vietnam/1194/2004 and H5N1 clade 2.2.1 A/turkey/Turkey/1/2005) at baseline (Day 0), 7 days and 28 days after the first dose, and 7 days and 28 days after the second dose (Day 35, Day 56)","definition_or_measurement_approach":"Measurement of serum MN antibody titres against heterologous strains at listed timepoints."}
• {"endpoint_text":"- Occurrence of all serious adverse events (SAEs) from the day of vaccination up to the study end","definition_or_measurement_approach":"Collection and reporting of all SAEs from vaccination day through study end; attribution and relatedness to study intervention assessed."}
• {"endpoint_text":"- Occurrence of all SAEs related to study intervention from the day of vaccination up to the study end","definition_or_measurement_approach":"Collection and reporting of SAEs assessed as related to the study intervention from vaccination day through study end."}

Norway

Earliest CTIS Part Ii Submission Date

10-09-2025

Latest Decision Or Authorization Date

11-11-2025

Processing Time Days

62

Number Of Sites

1

Number Of Participants

180

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"","full_name":"The European Vaccine Hub","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Haukeland University Hospital","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Influenza Centre, University of Bergen and Haukeland University Hospital.","duties_or_roles":"Source of monetary support","organisation_type":""}