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
Phase 2
Recruitment status
Completed
Participants
Lead sponsor
Hipra Scientific, S.L.U
Start date
2023-09-04
Number of sites
- 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.
- Short title
- 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
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2023-11-06
- First posted
- 2023-08-08
- Registry last updated
- 2024-02-26
- Primary completion date
- 2023-10-09
- Start date
- 2023-09-04
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Hipra Scientific, S.L.U
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05981846
- ClinicalTrials.gov ID
- NCT05981846
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
Timeframe: Day 0, Day 7
Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.
Timeframe: Day 0, Day 7, Day 28
Number and percentage of serious adverse events (SAEs) through the end of the study.
Timeframe: Day 0, Day 7, Day 28
Number and percentage of adverse events of special interest (AESI) through the end of the study
Timeframe: Day 0, Day 7, Day 28
Sources for outcomes
- Sex
- All
- Age groups
- Older adults
- Minimum age
- 65 Years
- Healthy volunteers
- Yes
- Adults aged 65 or older at Day 0.
- Are willing and able to sign the informed consent and can comply with all study visits and procedures.
- 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.
- Have a negative Rapid Antigen Test (RAT) at Day 0 before vaccinations.
- 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.
- 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.
- Allergy to egg proteins (egg or egg products) or chicken proteins.
- History of Guillain-Barré syndrome (GBS)
- History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30 days before Day 0.
- 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.
- 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).
- 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.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
- Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation.
- Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening.
- History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
Sources for eligibility
- Hospital Clínico Universitario de SantiagoSantiago de Compostela, Spain
- Hospital Germans Trias i PujolBadalona, Spain
- CAP CentellesCentelles, Spain
- Hospital HM ModeloA Coruña, Spain
- Hospital Clínic de BarcelonaBarcelona, Spain
- Hospital Josep TruetaGirona, Spain
- Hospital Regional de MálagaMálaga, Spain
- Hospital Clínico de ValladolidValladolid, Spain
Sources for sites