This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safetyand immunogenicity of BIMERVAX® when coadministered with seasonal surface antigeninactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of agefully vaccinated against COVID-19.In this study approximately 300 adults aged 65 or older will be enrolled and followed for1 month after study treatment. Safety and immunogenicity of all participants will beassessed.
Not Provided
Biological: BIMERVAX
One dose of booster vaccine
Biological: SIIV
One dose
Inclusion Criteria:
1. Adults aged 65 or older at Day 0.
  2. Are willing and able to sign the informed consent and can comply with all study
     visits and procedures.
  3. Participant must have received at least a primary scheme of an mRNA vaccine (2
     doses). Booster doses or previous COVID-19 infections are allowed. Last dose must
     have been administered at least 6 months before Day 0. History of COVID-19 infection
     is allowed if occurred at least >30 days before Day 0.
4. Have a negative Rapid Antigen Test (RAT) at Day 0 before vaccinations.
  5. Adults determined by clinical assessment, including medical history and clinical
     judgement, to be eligible for the study, including adults with pre-existing chronic
     and stable diseases (non-immunocompromised), if these are stable and well-controlled
     according to the investigator's judgment.
Exclusion Criteria:
  6. Acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination.
     Afebrile participants with minor illnesses can be enrolled at the discretion of the
     investigator.
7. Allergy to egg proteins (egg or egg products) or chicken proteins.
8. History of Guillain-Barré syndrome (GBS)
  9. History of COVID-19 infection (described as a positive RAT or PCR), in the previous
     30 days before Day 0.
 10. Other medical or psychiatric condition including recent (within the past year) or
     active suicidal ideation/behaviour that may increase the risk of study participation
     or, in the investigator's judgment, make the participant inappropriate for the
     study.
 11. History of severe adverse reaction associated with a vaccine and/or severe allergic
     reaction (e.g. anaphylaxis) to any component of the study intervention(s).
 12. Immunocompromised individuals defined as those with primary and secondary immune
     deficiencies and those receiving chemotherapy or immunosuppressant drugs other than
     steroids and glucocorticoids (maximum 30mg/day of prednisone, or equivalent, by any
     administration route for a maximum of 30 consecutive days), within 90 days prior to
     vaccination or during the study.
 13. Bleeding diathesis or condition associated with prolonged bleeding that would, in
     the opinion of the investigator, contraindicate intramuscular injection.
 14. Receipt of blood-derived immune globulins, blood, or blood-derived products in the
     past 3 months.
 15. Participation in other studies involving study intervention within 28 days prior to
     screening and/or during study participation.
 16. Received any non-study vaccine within 14 days before or after screening. For live or
     attenuated vaccines, 4 weeks before or after screening.
 17. History of a diagnosis or other conditions that, in the judgment of the
     investigator, may affect study endpoint assessment or compromise participant safety.
Hospital Clínico Universitario de Santiago
Santiago de Compostela	3109642, A Coruña, Spain
Hospital Germans Trias i Pujol
Badalona	3129028, Barcelona, Spain
CAP Centelles
Centelles	3125442, Barcelona, Spain
Hospital HM Modelo
A Coruña	3119841, Spain
Hospital Clínic de Barcelona
Barcelona	3128760, Spain
Hospital Josep Trueta
Girona	3121456, Spain
Hospital Regional de Málaga
Málaga	2514256, Spain
Hospital Clínico de Valladolid
Valladolid	3106672, Spain
Not Provided