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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Hipra Scientific, S.L.U · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS CoV 2 Infection
• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	BIMERVAX	One dose of booster vaccine
BIOLOGICAL	SIIV	One dose

Timeline

• Start date: 2023-09-04
• Primary completion: 2023-10-09
• Completion: 2023-11-06
• First posted: 2023-08-08
• Last updated: 2024-02-26

Locations

8 sites across 1 country: Spain