INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2); INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE STRAIN for Influenza

Inclusion criteria

• {"criterion_text":"- 1. Willing and able to give informed consent and able to adhere to all protocol-required study procedures."}
• {"criterion_text":"- 2. Adults ≥ 60 years of age who are overall healthy in the clinical judgment of the investigator based on the medical history and clinical assessment (including physical examination, vital signs, clinical laboratory tests). Subjects may have underlying illnesses as long as their symptoms/signs are controlled. If on regular prescribed medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination."}
• {"criterion_text":"- 3. Female subjects must be postmenopausal, defined as female subjects with at least 1 year of absence of menstruation or follicle-stimulating hormone and luteinizing hormone values of ovarian suppression."}
• {"criterion_text":"- 4. Ability to comply with study requirements, including the use of an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and other per-protocol required data."}

Exclusion criteria

• {"criterion_text":"- 1. History of allergy to egg or chicken proteins, or history of any reaction or hypersensitivity to a previous dose of influenza vaccine components."}
• {"criterion_text":"- 19. Any concurrent condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the study vaccine including (but not limited to) bleeding disorder, immunodeficiency, seizure disorder, or acute or progressive hepatic, renal, neurological, neuromuscular, or psychiatric disease."}
• {"criterion_text":"- 20. Any other reason that, in the investigator’s opinion, prohibits the inclusion of the subject into the study."}
• {"criterion_text":"- 2. History of serious adverse reaction to any influenza vaccine."}
• {"criterion_text":"- 3. History of Guillain-Barré syndrome."}
• {"criterion_text":"- 4. Laboratory confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment."}
• {"criterion_text":"- 5. Receipt of any vaccine within the preceding 4 weeks of study vaccination or planned vaccination within the 4-week period following each study vaccination."}
• {"criterion_text":"- 7. Having fever and/or acute disease or infection on the day of the first study vaccination (enrollment can be deferred for up to 2 weeks, provided the subject remains otherwise eligible). - Fever is defined as body temperature ≥ 38.0°C (measured by oral method). - Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator."}
• {"criterion_text":"- 8. Immunocompromising condition or immunosuppressive therapy within 6 months preceding enrollment."}
• {"criterion_text":"- 9. Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination."}
• {"criterion_text":"- 10. Chronic use of systemic corticosteroids at a dose ≥ 20 mg/day of prednisone or equivalent for 14 consecutive days or more, prior to the first study vaccination or planned use thereof during the study. Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed."}
• {"criterion_text":"- 11. Chronic systemic administration (defined as more than 14 days) of immunosuppressant or immune-modifying medication (such as monoclonal antibodies) for five elimination half-lives or the proposed time in Appendix 16.5, whichever is longer, prior to the first study vaccination or planned use thereof during the study."}
• {"criterion_text":"- 6. Planned administration of any influenza vaccine (other than the study vaccine) for the entire study period."}
• {"criterion_text":"- 12. Receipt of blood or blood products within 3 months preceding enrollment."}
• {"criterion_text":"- 13. Being a solid organ or bone marrow/stem cell transplant recipient."}
• {"criterion_text":"- 14. Use of cytotoxic drugs, anticancer chemotherapy, or radiation therapy within 36 months before the day of study vaccination."}
• {"criterion_text":"- 15. Receipt of another investigational agent within 30 days prior to study vaccination, or planned use during the entire study period."}
• {"criterion_text":"- 16. Known drug or alcohol abuse."}
• {"criterion_text":"- 17. Planned surgery requiring a general anesthetic, or planned surgery requiring inpatient hospitalization for at least 24 hours during the entire study period."}
• {"criterion_text":"- 18. Being an employee of the Sponsor/CRO conducting this study, personnel of the study site or placed in an institution by regulatory or legal ordinance."}

Primary endpoints

• {"endpoint_text":"- Postvaccination HI GMTs for each of the three strains 28 days (Day 29) after the first vaccination.","definition_or_measurement_approach":"Measured as hemagglutination-inhibition (HI) geometric mean titers (GMTs) for each of the three strains at Day 29 after the first vaccination."}

Secondary endpoints

• {"endpoint_text":"- 1. Postvaccination HI GMTs for each of the three strains after the revaccination.","definition_or_measurement_approach":"Measured as HI geometric mean titers (GMTs) for each of the three strains after revaccination."}
• {"endpoint_text":"- 2. Postvaccination VN GMTs for each of the three strains after the first and the revaccination.","definition_or_measurement_approach":"Measured as virus neutralization (VN) geometric mean titers (GMTs) for each strain after first vaccination and after revaccination."}
• {"endpoint_text":"- 3. Postvaccination HI and VN geometric mean fold increases (GMFIs) and seroconversion rates after the first and the revaccination.","definition_or_measurement_approach":"Calculated GMFIs for HI and VN assays and seroconversion rates after first vaccination and after revaccination."}
• {"endpoint_text":"- 4. Postvaccination reverse cumulative distribution (RCD) curves for HI and VN titers for each of the three strains after the first and the revaccination.","definition_or_measurement_approach":"RCD curves generated from HI and VN titer distributions for each strain after first vaccination and revaccination."}
• {"endpoint_text":"- 5. Postvaccination CMI values.","definition_or_measurement_approach":"Cell-mediated immunity (CMI) values measured postvaccination (assay specifics not detailed in the summary)."}
• {"endpoint_text":"- 6. Unsolicited (i.e., spontaneously reported) AEs within 28 days following each vaccination, including SAEs, AESIs, MAEs, and NCIs.","definition_or_measurement_approach":"Collection and reporting of unsolicited adverse events during the 28-day window after each vaccination, including serious adverse events (SAEs), adverse events of special interest (AESIs), medically attended events (MAEs), and new chronic illnesses (NCIs)."}
• {"endpoint_text":"- 7. Serious adverse events, AESIs, MAEs, and NCIs from Day 29 to Month 6 postvaccination (first vaccination only).","definition_or_measurement_approach":"Safety surveillance for SAEs, AESIs, MAEs, and NCIs from Day 29 through Month 6 after the first vaccination."}
• {"endpoint_text":"- 8. Solicited (i.e., prelisted in subject eDiary) injection site adverse reactions and systemic adverse reactions within 7 days following each vaccination. The following adverse reactions will be assessed (injection site): erythema, swelling, induration, pain, and ecchymosis, and (systemic): fever, headache, fatigue, malaise, myalgia, arthralgia, sweating, and shivering.","definition_or_measurement_approach":"Solicited local and systemic adverse reactions recorded in subject eDiary within 7 days after each vaccination; specific solicited events listed in the endpoint."}

Methods

• Flyers and posters (K2_Flyer, K2_Poster) in multiple language versions for local use at sites and community locations.
• Print advertisements (K2_Print Ad) in local media.
• Radio scripts (K2_Radio Script) for broadcast recruitment messages.
• Patient letters and GP letters (K2_Patient Letter, K2_GP Letter) sent to potential participants or healthcare providers.
• Phone call outreach (K2_Phone Call) and SMS reminders (K2_SMS to Potential Pt).
• Social media campaigns and website messages (K2_Social Media, K2_Website) including pre-screening webforms (K2_Pre-Screening via webform).
• Local site and research clinic outreach (site-specific materials such as K2_Recruit mat_FVR_FP, K2_Recruit mat_MeVac_FP).
• Recruitment partnerships/campaigns such as Vaccinopolis materials (K2_..._Vaccinopolis) where used.

Bulgaria

Earliest CTIS Part Ii Submission Date

30-05-2025

Latest Decision Or Authorization Date

19-06-2025

Processing Time Days

20

Number Of Sites

14

Number Of Participants

364

Estonia

Earliest CTIS Part Ii Submission Date

11-06-2025

Latest Decision Or Authorization Date

25-06-2025

Processing Time Days

14

Number Of Sites

6

Number Of Participants

240

Spain

Earliest CTIS Part Ii Submission Date

23-05-2025

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

31

Number Of Sites

8

Number Of Participants

133

Finland

Earliest CTIS Part Ii Submission Date

20-05-2025

Latest Decision Or Authorization Date

27-06-2025

Processing Time Days

38

Number Of Sites

11

Number Of Participants

276

Belgium

Earliest CTIS Part Ii Submission Date

21-05-2025

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

58

Number Of Sites

6

Number Of Participants

180

Primary sponsor

Full Name

Abbott Biologicals B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Operational sponsor duties including site identification, CDA analysis, pharmacovigilance and other sponsor duties (codes reported in dataset)

Third parties

• {"country":"United Kingdom","full_name":"MESM Ltd","duties_or_roles":"Ancillary supplies","organisation_type":"Industry"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,15 (Site identification, CDA analysis, pharmacovigilance),5,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement + payments","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Italy","full_name":"Vismederi S.r.l.","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}