This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19. In this study approximately 300 adults aged 65 or older will be enrolled and followed for 1 month after study treatment. Safety and immunogenicity of all participants will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
279
One dose of booster vaccine
One dose
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
CAP Centelles
Centelles, Barcelona, Spain
Hospital HM Modelo
A Coruña, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Josep Trueta
Girona, Spain
Hospital Regional de Málaga
Málaga, Spain
Hospital Clínico de Valladolid
Valladolid, Spain
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
Time frame: Day 0, Day 7
Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.
Time frame: Day 0, Day 7, Day 28
Number and percentage of serious adverse events (SAEs) through the end of the study.
Time frame: Day 0, Day 7, Day 28
Number and percentage of adverse events of special interest (AESI) through the end of the study
Time frame: Day 0, Day 7, Day 28
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