Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine
Trial Parameters
Brief Summary
This Phase 1/2 study is intended to assess the safety, tolerability, and immunogenicity of recombinant TVLP in adults 18-64 and 65 years of age and above and to confirm the dose(s) to be developed further in these two age cohorts.
Eligibility Criteria
Inclusion Criteria: 1. Participants must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; participants must also commit to complete study-related procedures and communicate with the study staff at visits and by phone during the study. 2. Participants must be 18 years of age and older at the Vaccination visit (Visit 2). 3. Participant must have a body mass index (BMI) ≤ 39 kg/m2 at the Vaccination visit (Visit 2). 4. Participants are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study. 5. Participants cannot be living in an institutionalized setting (e.g. not living in rehabilitation centres or assisted living facilities; living in an elderly community like independent senior housing is acceptable), must be in good general health, and have no acute or evolving medical problems prior to study participation and no clinically relevant abnorma