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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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).
. 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).