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.
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.
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.
Parallel
Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg
Biological/VaccineMonovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg + IB160 adjuvant (0.5mL total)
Monovalent influenza vaccine type A (H5N8) 15 mcg
Biological/VaccineMonovalent influenza vaccine type A (H5N8) 15 mcg + IB160 adjuvant (0.5mL total)
Placebo
Other interventionPhosphate buffered saline (PBS) (0.5 mL/dose).
Safety - Percentage of participants with solicited and unsolicited adverse events
Percentage (%) of participants with solicited (local and systemic) and unsolicited adverse events, for each intervention group, in adults and older adults.
Safety - Percentage of solicited and unsolicited adverse events by intensity degree
Percentage of solicited and unsolicited adverse events by intensity degree for each intervention group, in adults and older adults.
Safety - Percentage of participants with solicited and unsolicited adverse reactions
Percentage of participants with solicited and unsolicited adverse reactions, for each intervention group, in adults and older adults.
Safety - Percentage of solicited and unsolicited adverse reactions by intensity degree
Percentage of solicited and unsolicited adverse reactions by intensity degree for each intervention group, in adults and older adults.
Safety - Percentage of participants with unsolicited adverse events
Percentage of participants with unsolicited adverse events, for each intervention group, in adults and older adults.
Safety - Percentage and intensity of unsolicited adverse events
Percentage and intensity of unsolicited adverse events, for each intervention group, in adults and older adults.
Safety - Percentage of participants with unsolicited adverse reactions
Percentage of participants with unsolicited adverse reactions, for each intervention group, in adults and older adults.
Safety - Percentage and intensity of unsolicited adverse reactions
Percentage and intensity of unsolicited adverse reactions,, for each intervention group, in adults and older adults.
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Butantan Institute
Lead sponsor
Butantan Foundation
Collaborator
