Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented a… (NCT06842173) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults
Brazil700 participantsStarted 2025-09-10
Plain-language summary
This study aims to demonstrate the safety and immunogenicity of two formulations of the monovalent influenza vaccine candidate A (H5N8) (inactivated, fragmented, and adjuvanted with IB160) from the Instituto Butantan in adults and older adults, to be developed for situations of pandemic, epidemic or outbreak of avian type A/H5 in humans, in the context of pandemic preparedness.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and non-pregnant females aged ≥ 18 years at the time of the first study vaccination.
✓. Be in good health and clinically stable (defined as having no pre-existing health condition or having a pre-existing health condition that has not required a change in treatment or hospitalization for worsening of disease in the 3 months prior to the date of the first study vaccination).
✓. Agree to participate in the study and provide written informed consent prior to the initiation of any study procedures.
✓. Be able and willing to comply with all study procedures, including completing Participant Diaries, collecting blood samples, and being available for scheduled study visits and contacts.
✓. For females of childbearing potential, have a negative pregnancy test prior to the first study vaccination.
✓. For women of childbearing potential, be willing to use effective contraceptive measures during the screening visit until at least 30 days after the second study vaccination.
Exclusion criteria
✕. Having received any vaccine (including seasonal influenza) 28 days prior to the date of the first study vaccination or having any vaccination in the period from the first vaccination to the immune response assessment visit after the last vaccination.
✕. Known hypersensitivity or allergy to eggs, chicken proteins, squalene-based adjuvants, or any other component of the investigational product.
✕. History of serious adverse reaction or anaphylaxis to any previous influenza vaccine (licensed or not).
What they're measuring
1
Safety - Percentage of participants with solicited and unsolicited adverse events
Timeframe: 7 days post each vaccination.
2
Safety - Percentage of solicited and unsolicited adverse events by intensity degree
Timeframe: 7 days post each vaccination
3
Safety - Percentage of participants with solicited and unsolicited adverse reactions
Timeframe: 7 days post each vaccination
4
Safety - Percentage of solicited and unsolicited adverse reactions by intensity degree
Timeframe: 7 days post each vaccination
5
Safety - Description of solicited adverse reactions, regarding duration, time until onset and use of medication
Timeframe: 7 days post each vaccination
6
Immunogenicity - Seroconversion rate post second vaccination
Timeframe: 21 days post second vaccination
7
Immunogenicity - Seroprotection rate post second vaccination
✕. Having received any influenza A/H5 vaccine or history of exposure to avian influenza A/H5.
✕. Presence of a bleeding disorder or any condition that contraindicates intramuscular injection.
✕. Having received immunoglobulin, blood, or any blood-derived product in the 3 months prior to the date of the first study vaccination or having had immunoglobulin or blood-derived product administered during the entire follow-up of the study.
✕. Having received a solid organ, bone marrow, or stem cell transplant.
✕. Having a history of asplenia (anatomic or functional).