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
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BIMERVAX + SIIV
|
Biological: BIMERVAX
One dose of booster vaccine
Biological: SIIV
One dose
|
| Active Comparator: BIMERVAX + PLACEBO
|
Biological: BIMERVAX
One dose of booster vaccine
|
| Active Comparator: SIIV + PLACEBO
|
Biological: SIIV
One dose
|
Outcome Measures
Primary Outcome Measures
- Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination. [Day 0, Day 7]
- Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study. [Day 0, Day 7, Day 28]
- Number and percentage of serious adverse events (SAEs) through the end of the study. [Day 0, Day 7, Day 28]
- Number and percentage of adverse events of special interest (AESI) through the end of the study [Day 0, Day 7, Day 28]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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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:
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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.
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Allergy to egg proteins (egg or egg products) or chicken proteins.
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History of Guillain-Barré syndrome (GBS)
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History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30 days before Day 0.
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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.
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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).
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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.
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Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
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Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
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Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation.
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Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening.
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History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínico Universitario de Santiago | Santiago De Compostela | A Coruña | Spain | 15706 |
| 2 | Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain | 08916 |
| 3 | CAP Centelles | Centelles | Barcelona | Spain | 08540 |
| 4 | Hospital HM Modelo | A Coruña | Spain | 15011 | |
| 5 | Hospital Clínic de Barcelona | Barcelona | Spain | 08036 | |
| 6 | Hospital Josep Trueta | Girona | Spain | 17001 | |
| 7 | Hospital Regional de Málaga | Málaga | Spain | 29010 | |
| 8 | Hospital Clínico de Valladolid | Valladolid | Spain | 47003 |
Sponsors and Collaborators
- Hipra Scientific, S.L.U
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HIPRA-HH-11