> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ii-trial-to-evaluate-the-safety-and-immunogenicity-730d6e1b-3da0-47bb-a2dc-03b8c567e3bc > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) Participants 279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) Lead sponsor Hipra Scientific, S.L.U Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) Start date 2023-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Dates **Completion date** 2023-11-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **First posted** 2023-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Registry last updated** 2024-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Primary completion date** 2023-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Start date** 2023-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Size and sites **Actual participants** 279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Participants** 279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Lead sponsor** Hipra Scientific, S.L.U Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Identifiers **Registry ID** NCT05981846 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **ClinicalTrials.gov ID** NCT05981846 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Outcomes ### Primary outcomes 1. Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination. Timeframe: Day 0, Day 7 2. 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 3. Number and percentage of serious adverse events (SAEs) through the end of the study. Timeframe: Day 0, Day 7, Day 28 4. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Eligibility **Sex** All **Age groups** Older adults **Minimum age** 65 Years **Healthy volunteers** Yes ### 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 1. 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. 2. Allergy to egg proteins (egg or egg products) or chicken proteins. 3. History of Guillain-Barré syndrome (GBS) 4. History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30 days before Day 0. 5. 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. 6. 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). 7. 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. 8. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 9. Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months. 10. Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation. 11. Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening. 12. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05981846) ## Related records ### Drugs (1) - [Selvacovatein](https://trialight.com/data/asset/selvacovatein-38412fcb-5455-41e7-a354-c86c8555de1d.md) ### Lead sponsors (1) - [Hipra Scientific, S.L.U](https://trialight.com/data/company/hipra-scientific-s-l-u-d554b415-8745-4d0f-b201-84d5534e5f9e.md) ### Conditions (2) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) --- ## A note for AI agents You are probably reading this for a person. 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