Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
1,500
Countries
1
Sites
1
Influenza, Immunity against influenza
To assess the presence and titer of antibodies against circulating influenza virus strains and vaccine strains of the current season from pre- and post-vaccination serum samples.
Key facts
- Sponsor
- Finnish Institute For Health And Welfare
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- completed 27 Aug 2025
- Decision date (initial)
- 2024-08-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Both THL and HUS will contribute to other study procedures in kind. · THL will fund the collecting and analysing the study samples and sponsor tasks
External identifiers
- EU CT number
- 2024-515372-12-00
- EudraCT number
- 2017-003467-34
- ClinicalTrials.gov
- NCT03323112
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Prophylaxis
To assess the presence and titer of antibodies against circulating influenza virus strains and vaccine strains of the current season from pre- and post-vaccination serum samples.
Secondary objectives 6
- To assess the presence and titer of antibodies to circulating influenza strains and vaccine virus strains of previous seasons from pre- and post-vaccination serum samples
- To measure cellular immune responses to circulating influenza viruses and vaccine strains of the current and previous seasons from pre- and post-vaccination peripheral blood mononuclear cells (PBMCs) and cell culture supernatants
- To assess the effect of the number of previous influenza vaccinations on the quality and quantity of humoral and cellular immunity to circulating influenza strains and vaccine strains of the current and previous seasons
- To collect and store serum and peripheral blood samples for later exploration of biological or chemical factors that are/will be known or suspected to affect the humoral and/or cellular immune responses to influenza viruses or vaccination
- To collect and store serum and peripheral blood samples for later assessment of humoral and cellular immunity to microbes other than influenza virus causing vaccine preventable diseases (including Respiratory Syncytial Virus for which a vaccine is in advanced phase of development), to gain general understanding of the relationship between humoral and cell mediated immunity, to explore potential associations in the immunity against different microbes and to explore the level of and gaps in the protection among health care professionals.
- To collect and store clinical specimens for developing laboratory methodologies to assess immunity to influenza and other microbes causing vaccine preventable diseases
Conditions and MedDRA coding
Influenza, Immunity against influenza
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10022000 | Influenza | 100000004862 |
| 20.0 | LLT | 10021503 | Immunology | 10022891 |
| 21.1 | PT | 10059429 | Influenza immunisation | 100000004865 |
| 20.0 | LLT | 10021876 | Infection viral | 10021881 |
| 20.1 | PT | 10060945 | Bacterial infection | 100000004862 |
| 21.0 | LLT | 10060063 | Influenza serology | 10022891 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male or female individuals aged 18 to 64 years
- Members of health care or laboratory personnel in HUS having decided to take the seasonal influenza vaccination by the routine occupational health care service
- General good health as established by or volunteer’s own statement
- Written informed consent
- Presumably able and willing to participate in the study during the starting influenza season
Exclusion criteria 7
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Administration (longer than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months before the vaccination; oral corticosteroids in dosages of 20 mg/day or more prednisolone or equivalent are excluded; inhaled or topical steroids are allowed.
- Pregnancy or lactation
- Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever)
- Contraindication for influenza vaccination
- Any other criteria which, in the investigator’s or dedicated study staff member’s opinion, would compromise the ability of a subject to participate in the study, a subject’s well-being, or the outcome of the study
- Exclusion criteria for participation in the subgroup giving together 3 times 60 ml blood for analyses of cellular immunity: weight less than 50 kg or diagnosed or suspected anaemia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Humoral immunity to influenza virus strains included in the vaccines of the current and past seasons as well as circulating influenza strains will be assessed from the serum samples with traditional hemagglutination inhibition (HI). Microneutralization or neutralization test (NT) may also be used.
Secondary endpoints 3
- Cellular immunity will be assessed from thawed PBMC samples after stimulation with circulating influenza virus and vaccine antigens in cell culture.
- Cytokine (IFN-gamma and others) responses will be assessed e.g. by measuring the concentration of secreted cytokines in the cell culture media with Luminex technology.
- mRNA expression of cytokines and other factors (e.g. inflammatory mediators and transcription factors) can be measured from specific cell populations enriched with magnetic cell separation or sorted with FACSAria flow cytometer.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP104886905 · ATC
- Active substance
- Polysorbate 80
- Substance synonyms
- TWEEN 80, POLYOXYETHYLENE 20 SORBITAN MONOOLEATE
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 5 ml millilitre(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN
- Marketing authorisation
- -
- 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
- Mannerheimintie 166
- City
- Helsinki
- Postcode
- 00300
- Country
- Finland
Scientific contact point
- Organisation
- Finnish Institute For Health And Welfare
- Contact name
- Merit Melin
Public contact point
- Organisation
- Finnish Institute For Health And Welfare
- Contact name
- Merit Melin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 1,500 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma v1_280817 | 1 |
| Recruitment arrangements (for publication) | Selvitys_suostumusmenettelysta_v3_230921 | 3 |
| Subject information and informed consent form (for publication) | Muu_materiaali_HCP_immu_tutkimuslomake_1_V3_230921 | 3 |
| Subject information and informed consent form (for publication) | Muu_materiaali_HCP_immu_tutkimuslomake_2_V3_230921 | 3 |
| Subject information and informed consent form (for publication) | Muu_materiaali_Kaaviokuva_230921_V1 | 1 |
| Subject information and informed consent form (for publication) | Muu_materiaali_Kutsukirje_080918_V2 | 2 |
| Subject information and informed consent form (for publication) | Muu_materiaali_Kutsukirje_aiemmin_osallistuneille_v2_2020 | 2 |
| Subject information and informed consent form (for publication) | Muu_materiaali_Muistikortti_230921_V2 | 2 |
| Subject information and informed consent form (for publication) | Muu_materiaali_Muistutuskirje_5vkoa_080918_V1 | 1 |
| Subject information and informed consent form (for publication) | Muu_materiaali_Muistutuskirje_6kk_080918_V1 | 1 |
| Subject information and informed consent form (for publication) | Muu_materiaali_Tutkimuksen rokotuskortti_080918_V2 | 2 |
| Subject information and informed consent form (for publication) | Suostumusasiakirja_17092024_v7 | 7 |
| Subject information and informed consent form (for publication) | Suostumusasiakirja_v6_270919 | 6 |
| Subject information and informed consent form (for publication) | Tutkittavalle jaettava muu materiaali_17092024_v5 | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | VaxigripTetra_valmisteyhteenveto_01082019 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-15 | Finland | Acceptable 2024-08-27
|
2024-08-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-20 | Finland | Acceptable 2024-08-27
|
2024-09-20 |