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Avian and seasonal influenza vaccine induced immune responses

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509178-44-00
Acronym
Avian_inf_vacc_THL20
Enrollment
300
Registered
2024-04-19
Start date
2024-06-26
Completion date
Unknown
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avian influenza and seasonal influenza

Brief summary

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

Detailed description

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

Interventions

DRUGadjuvanted)
DRUGZoonotic Influenza Vaccine Seqirus suspension for injection in pre-filled syringe Zoonotic influenza vaccine (H5N8) (surface antigen
DRUGVaxigrip injektioneste
DRUGesitäytetty ruisku. Kolmivalenttinen influenssarokote (virusfragmentit
DRUGinaktivoitu).
DRUGFluad suspension for injection in pre-filled syringe Influenza vaccine (surface antigen
DRUGZoonotic Influenza Vaccine Seqirus suspension for injection in pre-filled syringe. Zoonotic influenza vaccine (H5N1) (surface antigen
DRUGadjuvanted).
DRUGesitäytetty ruisku. Nelivalenttinen influenssarokote (virusfragmentit
DRUGinaktivoitu)

Sponsors

Finnish Institute For Health And Welfare
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026