Status:
COMPLETED
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
Lead Sponsor:
Hipra Scientific, S.L.U
Conditions:
SARS CoV 2 Infection
Influenza, Human
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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 influen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2023
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT05981846
Start Date
September 4 2023
End Date
November 6 2023
Last Update
February 26 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
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