Skip to content

A Phase I/II multicenter, randomized, double-blind, dose-selecting trial to investigate the immunogenicity, reactogenicity and safety of an intradermally administered zoonotic influenza vaccine targeting H5N8 in different doses compared with intramuscular administration of the same vaccine in adults aged 40 to 80 years

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525756-28-00
Enrollment
60
Registered
2026-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-29

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

Conditions

Avian Influenza

Brief summary

HI antibody titers expressed as group GMT ratio 1 month after the second dose the H5N8 vaccine (at Day 57)., HI seroconversion rates 1 month after the second dose of the H5N8 vaccine (From Day 1 to Day 57)

Detailed description

Occurrence of solicited administration site AEs with onset within 7 days (i.e. from Day 1 to Day 7 included) of each study intervention administration, Occurrence of solicited systemic AEs with onset within 7 days (i.e. from Day 1 to Day 7 included) of each study intervention administration, Occurrence of unsolicited AEs with onset within 28 days (i.e. from Day 1 to Day 28 included) of each study intervention administration, Occurrence of AESIs within 6 months (i.e. from Day 1 to Day 181 included) of study intervention administration, Occurrence of SAEs within 6 months (i.e. from Day 1 to Day 181 included) of study intervention administration, Occurrence of SAEs related to study participation from signing of ICF up to end of study

Interventions

Sponsors

University Of Antwerp
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
HI antibody titers expressed as group GMT ratio 1 month after the second dose the H5N8 vaccine (at Day 57)., HI seroconversion rates 1 month after the second dose of the H5N8 vaccine (From Day 1 to Day 57)—

Secondary

MeasureTime frame
Occurrence of solicited administration site AEs with onset within 7 days (i.e. from Day 1 to Day 7 included) of each study intervention administration, Occurrence of solicited systemic AEs with onset within 7 days (i.e. from Day 1 to Day 7 included) of each study intervention administration, Occurrence of unsolicited AEs with onset within 28 days (i.e. from Day 1 to Day 28 included) of each study intervention administration, Occurrence of AESIs within 6 months (i.e. from Day 1 to Day 181 included) of study intervention administration, Occurrence of SAEs within 6 months (i.e. from Day 1 to Day 181 included) of study intervention administration, Occurrence of SAEs related to study participation from signing of ICF up to end of study—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 30, 2026