Clinical trial • Phase IV • Respiratory | Infectious Disease

A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23) for Avian influenza | Seasonal influenza

Phase IV trial of A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23) for Avian influenza | Seasonal influenza. 300 participants.

Overview

Trial Therapeutic Area: Respiratory | Infectious Disease
Trial Disease: Avian influenza | Seasonal influenza
Trial Stage: Phase IV
Drug Modality: Vaccine

Key dates

Initial CTIS Submission Date: 21-12-2023
First CTIS Authorization Date: 19-04-2024

Trial design

Phase IV trial across 1 site in Finland.

Single Multiple Or Escalation Dose Combined: Yes
Target Sample Size: 300
Trial Duration For Participant: 365

Eligibility

Recruits 300 isVulnerablePopulationSelected = true. Participants must be able to understand the given written and oral information and must give written informed consent (no assent procedures described). Age inclusion is 18 to 65 years (adult participants)..

Pregnancy Exclusion: Pregnant and lactating women can participate in the study
Vulnerable Population: isVulnerablePopulationSelected = true. Participants must be able to understand the given written and oral information and must give written informed consent (no assent procedures described). Age inclusion is 18 to 65 years (adult participants).

Inclusion criteria

{"criterion_text":"- Age 18 to 65 years\n- Belongs to the target group of the avian influenza vaccine\n- Is planning to receive at least one dose of the avian influenza vaccine\n- Is able to understand the given written and oral information\n- Has given written informed consent\n- Home address in Finland\n- Is able to give samples 3 weeks after each vaccine dose and preferably also participate in the follow-up at 6 and 12 months\n- Pregnant and lactating women can participate in the study"}

Exclusion criteria

{"criterion_text":"- None"}

Endpoints

Primary endpoints

{"endpoint_text":"- Primary outcome measure: Seroconversion proportion in all study subjects 3 weeks after the second dose given at least 21 days after the first dose, as assessed by the microneutralization test","definition_or_measurement_approach":"Seroconversion proportion measured 3 weeks after the second dose, assessed by the microneutralization test (MNT)."}

Secondary endpoints

{"endpoint_text":"- Rate of seroconversion defined as the percentage of subjects with either a pre-vaccination MNT titer < 1:10 and a post vaccination MNT titer ≥ 1:80 or a pre-vaccination MNT titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.","definition_or_measurement_approach":"Rate of seroconversion defined by MNT and HI antibody titer criteria (pre-vaccination and post-vaccination thresholds and four-fold rise)."}
{"endpoint_text":"- Geometric mean titers at pre- and post-vaccination","definition_or_measurement_approach":"Geometric mean titers (GMT) measured pre-vaccination and post-vaccination."}
{"endpoint_text":"- Detectable increase in T cell (CD4+ and CD8+) responses against H5N1 virus specific antigens in avian influenza virus vaccinated individuals","definition_or_measurement_approach":"Assessment of detectable increase in CD4+ and CD8+ T cell responses against H5N1-specific antigens (cellular immune response measures)."}

Recruitment

Digital Remote Recruitment: Yes
Planned Sample Size: 300
Recruitment Window Months: 130
Consent Approach: Written informed consent is required: participants must be able to understand the given written and oral information and must provide written informed consent. Multiple subject information and informed consent form documents are listed (subject information and consent forms). Materials include Finnish-language translations/documents.

Methods

Invitation letters (Kutsukirje) to potential participants (document titles indicate targeted invitation letters).
Target-group specific information letters (Infokirje) directed to laboratory staff and to fur farm and poultry farm workers (document: Lintuinfluenssatutkimus_Infokirje2_turkistarhaajat_siipikarjatilalliset).
Website information (document: Lintuinfluenssatutkimus_verkkosivut).
Appointment booking and sample collection instructions (documents titled Ajanvaraus- and nayteohje).
Reminder messages to participants (document: Muistutusviesti tutkittavalle_v1_28102024).

Geography

Total Number Of Sites: 1
Total Number Of Participants: 300

Finland

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 26-05-2025
Processing Time Days: 454
Number Of Sites: 1
Number Of Participants: 300

Sites

Site Name: Finnish Institute For Health And Welfare
Department Name: Terveysturvaajat -osasto
Principal Investigator Name: Hanna Nohynek
Principal Investigator Email: hanna.nohynek@thl.fi
Contact Person Name: Hanna Nohynek
Contact Person Email: hanna.nohynek@thl.fi
Number Of Participants: 300

Sponsor

Primary sponsor

Full Name: Finnish Institute For Health And Welfare
Organisation Type: Laboratory/Research/Testing facility
Country Of Registered Address: Finland

Investigational products

Investigational Product Name: Zoonotic Influenza Vaccine Seqirus suspension for injection in pre-filled syringe. Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Active Substance: A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23)
Modality: Vaccine
Routes Of Administration: INTRAMUSCULAR
Route: INTRAMUSCULAR
Authorisation Status: Authorised
Maximum Dose: 1.0 ml millilitre(s)

Investigational Product Name: VaxigripTetra, injektioneste, suspensio, esitäytetty ruisku. Nelivalenttinen influenssarokote (virusfragmentit, inaktivoitu)
Active Substance: B/PHUKET/3073/2013-LIKE VIRUS; INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2); INFLUENZA VIRUS B/MICHIGAN/01/2021; INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED
Modality: Vaccine
Routes Of Administration: INTRAMUSCULAR OR SUBCUTANEOUS
Route: INTRAMUSCULAR OR SUBCUTANEOUS
Authorisation Status: Authorised
Maximum Dose: 0.5 ml millilitre(s)

Investigational Product Name: Zoonotic Influenza Vaccine Seqirus suspension for injection in pre-filled syringe Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted)
Active Substance: INFLUENZA A/ASTRAKHAN/3212/2020 (H5N8)-LIKE STRAIN (CBER-RG8A) (CLADE 2.3.4.4B)
Modality: Vaccine
Routes Of Administration: INTRAMUSCULAR INJECTION
Route: INTRAMUSCULAR INJECTION
Authorisation Status: Authorised
Maximum Dose: 1 ml millilitre(s)

Investigational Product Name: Fluad suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, adjuvanted)
Active Substance: INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN; INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED; INFLUENZA A VIRUS, A/CROATIA/10136RV/2023 (H3N2) LIKE STRAIN X-425A, INACTIVATED
Modality: Vaccine
Routes Of Administration: INTRAMUSCULAR INJECTION
Route: INTRAMUSCULAR INJECTION
Authorisation Status: Authorised
Maximum Dose: 0.5 ml millilitre(s)

Investigational Product Name: Fluad Tetra, suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, adjuvanted)
Active Substance: B/PHUKET/3073/2013-LIKE STRAIN; INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN; INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED; INFLUENZA VIRUS A/THAILAND/8/2022 (H3N2) IVR-237-LIKE STRAIN
Modality: Vaccine
Routes Of Administration: INTRAMUSCULAR INJECTION
Route: INTRAMUSCULAR INJECTION
Authorisation Status: Authorised
Maximum Dose: 0.5 ml millilitre(s)

Investigational Product Name: Vaxigrip injektioneste, suspensio, esitäytetty ruisku. Kolmivalenttinen influenssarokote (virusfragmentit, inaktivoitu).
Active Substance: INFLUENZA VIRUS B/MICHIGAN/01/2021; INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED; INFLUENZA A VIRUS, A/CROATIA/10136RV/2023 (H3N2) LIKE STRAIN X-425A, INACTIVATED
Modality: Vaccine
Routes Of Administration: INTRAMUSCULAR INJECTION
Route: INTRAMUSCULAR INJECTION
Authorisation Status: Authorised
Maximum Dose: 0.5 ml millilitre(s)

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