Unvaccinated healthy adults for H5 subtype
Conditions
Sponsors
Saito Sho
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adults aged 18 years or older who have not yet been vaccinated against the H5 subtype at the time of informed consent.
Exclusion criteria
Exclusion criteria: 1) Individuals who have a clear history of H5 subtype influenza (as reported by the subject) 2) Individuals who have previously experienced anaphylaxis due to food, medication or other substances 3) Individuals who have a current history of serious diseases affecting the cardiovascular, hematological, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric systems. 4) Individuals with a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis 5) Individuals with confirmed influenza infection during the current season (2025/2026) (up to the first vaccination)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity against A/H5 subtype avian influenza virus (HI antibody titer, etc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Side reactions and adverse events. In the event that the HPAIV H5 subtype belonging to Clade 2.3.4.4b becomes a pandemic influenza in the future, serum samples will be stored at the National Institute of Infectious Diseases to estimate the effectiveness of this stockpile vaccine. | — |
Contacts
Public ContactSho Saito
Japan Institute for Health Security National Center for Global Health and Medicine
Outcome results
None listed