Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
1
Avian influenza and seasonal influenza
The main objective of this study is to evaluate the humoral and cell-mediated immune responses induced by the customized avian influenza vaccine, specifically against the H5N1 2.3.4.4b clade.
Key facts
- Sponsor
- Finnish Institute For Health And Welfare
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 26 Jun 2024 → ongoing
- Decision date (initial)
- 2024-04-19
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Finnish Institute for Health and Welfare
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
The main objective of this study is to evaluate the humoral and cell-mediated immune responses induced by the customized avian influenza vaccine, specifically against the H5N1 2.3.4.4b clade.
Secondary objectives 5
- To evaluate humoral immune responses produced by the avian influenza vaccine against different H5N1 development lineages (clades) that have occurred before 2023, or that are identified to occur during the study
- To evaluate cellular immune responses induced by the customized avian influenza vaccine, against different H5N1 clades
- To evaluate the effects of prior seasonal influenza vaccines on the immune responses induced by the avian influenza vaccine
- To evaluate humoral immunity produced by seasonal influenza vaccinations against different H5N1 lineages evaluated from samples collected from healthcare personnel belonging to the target group of the seasonal influenza vaccine (“Immune responses to influenza vaccinations and viruses among health care personnel”, ClinicalTrials.gov Identifier: NCT03323112)
- To evaluate humoral and cellular immune responses induced by the H5N1 2.3.4.4b customized vaccine in subjects who have previously received avian influenza vaccines
Conditions and MedDRA coding
Avian influenza and seasonal influenza
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Age 18 to 65 years
- Belongs to the target group of the avian influenza vaccine
- Is planning to receive at least one dose of the avian influenza vaccine
- Is able to understand the given written and oral information
- Has given written informed consent
- Home address in Finland
- Is able to give samples 3 weeks after each vaccine dose and preferably also participate in the follow-up at 6 and 12 months
- Pregnant and lactating women can participate in the study
Exclusion criteria 1
- None
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 3
- 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.
- Geometric mean titers at pre- and post-vaccination
- Detectable increase in T cell (CD4+ and CD8+) responses against H5N1 virus specific antigens in avian influenza virus vaccinated individuals
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD4506899 · Product
- Active substance
- BPHUKET30732013-LIKE Virus (BPHUKET30732013, Wild Type)
- Substance synonyms
- B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), B/Phuket/3073/2013-like strain (B/Yamagata/16/88 lineage) (B/Phuket/3073/2013, wild type)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR OR SUBCUTANEOUS
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- 33654
- MA holder
- SANOFI PASTEUR EUROPE
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10931113 · Product
- Active substance
- ATURKEYTURKEY105 (H5N1-LIKE Strain (NIBRG-23)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1.0 ml millilitre(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- EU/1/23/1761/001
- MA holder
- SEQIRUS S.R.L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10931114 · Product
- Active substance
- Influenza AASTRAKHAN32122020 (H5N8-LIKE Strain (CBER-RG8A) (Clade 2344B)
- Pharmaceutical form
- SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- EU/1/23/1761/002
- MA holder
- SEQIRUS S.R.L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12027853 · Product
- Active substance
- Influenza Virus BMICHIGAN012021
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- 43635
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8090559 · Product
- Active substance
- BPHUKET30732013-LIKE Strain (BPHUKET30732013, BVR-1B)
- Substance synonyms
- Influenza (Eggs) inactivated virus (split virion) (B/Phuket/3073/2013 BVR1B (B/Yamagata lineage) strain
- Pharmaceutical form
- SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- EU/1/20/1433/001
- MA holder
- SEQIRUS NETHERLANDS B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11777909 · Product
- Active substance
- Influenza Virus BAUSTRIA13594172021-LIKE Strain (BAUSTRIA13594172021, BVR-26)
- Substance synonyms
- B/Austria/1359417/2021 (B/Victoria lineage)-like virus (B/Austria/1359417/2021 BVR-26)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- EU/1/24/1878/002
- MA holder
- SEQIRUS NETHERLANDS B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Finnish Institute For Health And Welfare
- Sponsor organisation
- Finnish Institute For Health And Welfare
- Address
- P. O. Box 30
- City
- Helsinki
- Postcode
- 00271
- Country
- Finland
Scientific contact point
- Organisation
- Finnish Institute For Health And Welfare
- Contact name
- Hanna Nohynek
Public contact point
- Organisation
- Finnish Institute For Health And Welfare
- Contact name
- Hanna Nohynek
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 300 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-06-26 | 2024-07-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Avian_influenza_vaccine_study_research_plan_v1_12122023 | 3 |
| Recruitment arrangements (for publication) | Recruitment and Informed consent procedure_Avian_inf_vacc_THL2023 | 5 |
| Subject information and informed consent form (for publication) | Ajanvaraus- ja nayteohje_jatkokaynnit_yleinen_v1_12122023 | 3 |
| Subject information and informed consent form (for publication) | Kohderyhmittaiset infokirjeiden saatetekstit | 1 |
| Subject information and informed consent form (for publication) | Lintuinfluenssatutkimus_Ajanvaraus_nayteohje_yleinen_v1_12122023 | 3 |
| Subject information and informed consent form (for publication) | Lintuinfluenssatutkimus_Infokirje1_laboratorio_ell_v1_12122023 | 3 |
| Subject information and informed consent form (for publication) | Lintuinfluenssatutkimus_Infokirje2_turkistarhaajat_siipikarjatilalliset_v1_12122023 | 3 |
| Subject information and informed consent form (for publication) | Lintuinfluenssatutkimus_Kutsukirje_jatkokaynnit_v1_12122023 | 1 |
| Subject information and informed consent form (for publication) | Lintuinfluenssatutkimus_Kutsukirje_v1_12122023 | 2 |
| Subject information and informed consent form (for publication) | Lintuinfluenssatutkimus_Suostumusasiakirja_v1_12122023 | 5 |
| Subject information and informed consent form (for publication) | Lintuinfluenssatutkimus_Tutkittavan tiedote_v1_12122023 | 4 |
| Subject information and informed consent form (for publication) | Lintuinfluenssatutkimus_verkkosivut | 2.0 |
| Subject information and informed consent form (for publication) | Muistutusviesti tutkittavalle_v1_28102024 | 1 |
| Subject information and informed consent form (for publication) | Saatetekstin tarkennukset | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Fluad Tetra-epar-product-information_fi_2024-2025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Fluad-epar-product-information_en_2025-2026 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Valmisteyhteenveto_Vaxigrip Tetra 2024-2025 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Valmisteyhteenveto_Vaxigrip_2025-2026 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | VaxigripTetra_valmisteyhteenveto_23155150 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | zoonotic-influenza-vaccine-seqirus-epar-product-information_en | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | zoonotic-influenza-vaccine-seqirus-epar-product-information_en | 2 |
| Synopsis of the protocol (for publication) | Abstract_Avian_inf_vacc_THL2023 | 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-21 | Finland | Acceptable with conditions 2024-04-15
|
2024-04-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-23 | Finland | Acceptable with conditions 2024-04-15
|
2024-04-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-29 | Finland | Acceptable with conditions 2024-06-05
|
2024-06-07 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-07 | Finland | Acceptable with conditions 2024-06-05
|
2024-10-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-08 | Finland | Acceptable 2025-01-28
|
2025-01-31 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-22 | Finland | Acceptable | 2025-05-26 |
| 7 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-12-11 | Finland | Acceptable 2026-01-20
|
2026-01-21 |