drugset / Trial / NCT05981846

A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19

NCT05981846 ↗

Phase 2 Completed 279 enrolled Hipra Scientific, S.L.U
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2023-09-04
Primary completion
2023-10-09
Completion
2023-11-06

Drugs

EvaluationDrugModalityDoseRoute
Subject SELVACOVATEIN Vaccine — —
Subject SIIV Vaccine — —

Indications