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Immunogenicity of licensed MF59 adjuvanted Influenza and SARS-CoV-2 vaccine combinations for Older Adults (ISOLDA)
EU CTIS ID: 2024-514798-23-00
What this study is testing
The primary objective of this trial is to assess the humoral immune response elicited by a licensed COVID-19 vaccine when co-administered with a licensed MF59 adjuvanted seasonal FLU vaccine in adults aged 65 years and over, relative to the licensed COVID-19 vaccine co-administered with an unadjuvanted seasonal FLU vaccine or the COVID-19 vaccine alone.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Willingness to provide written informed consent.
- Men or women aged 65 years or older at the time of consent.
- Ability to comply with the trial protocol requirements
You likely can't join if
- Presence of any chronic disease, or history of significant disease, that might interfere with the conduct or completion of the trial. Certain conditions may be accepted if they have been stable for at least 3 months preceding the start of the trial (visit 1), such as hypertension, at discretion of the Investigator.
- Being an employee of the Investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee or the Investigator.
- Use of B-cell depleting therapy (i.e. Rituximab) within 12 months prior to vaccination, or within 90 days following vaccination
- Reported Human Immunodeficiency Virus (HIV) infection with a CD4 lymphocyte count of < 100 cells per mm3 in the year prior to vaccination
- Administration of immunosuppressant or immuno-modifying drugs for more than 3 months prior of trial start, or intended future use of any other immunosuppressant medication, judged by the Investigator to result in a severely reduced response to the vaccine. Asthma inhalers are exempt from this requirement.
- Use of systemic corticosteroids ≥20 mg of prednisone per day, or equivalent within 28 days prior to vaccination, or planned treatment within 90 days following vaccination
See the full eligibility criteria
- Willingness to provide written informed consent.
- Men or women aged 65 years or older at the time of consent.
- Ability to comply with the trial protocol requirements
- Presence of any chronic disease, or history of significant disease, that might interfere with the conduct or completion of the trial. Certain conditions may be accepted if they have been stable for at least 3 months preceding the start of the trial (visit 1), such as hypertension, at discretion of the Investigator.
- Being an employee of the Investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee or the Investigator.
- Use of B-cell depleting therapy (i.e. Rituximab) within 12 months prior to vaccination, or within 90 days following vaccination
- Reported Human Immunodeficiency Virus (HIV) infection with a CD4 lymphocyte count of < 100 cells per mm3 in the year prior to vaccination
- Administration of immunosuppressant or immuno-modifying drugs for more than 3 months prior of trial start, or intended future use of any other immunosuppressant medication, judged by the Investigator to result in a severely reduced response to the vaccine. Asthma inhalers are exempt from this requirement.
- Use of systemic corticosteroids ≥20 mg of prednisone per day, or equivalent within 28 days prior to vaccination, or planned treatment within 90 days following vaccination
- Confirmed or suspected (at the discretion of the Investigator) immuno-suppressive or immuno-deficient condition.
- Receipt of a blood transfusion, blood products, or immunoglobulins within the 3-month period preceding start of the trial (Visit 1), or planned infusion within 90 days after the end of the trial.
- Presence of acute disease and/or fever (≥38°C measured by the oral route) at the time of vaccine administration.
- Vaccinated with any SARS-CoV-2 vaccine, or history of documented COVID-19, within four months prior to trial vaccination
- Vaccination with a FLU vaccine within a 6-month period preceding the start of the trial (Visit 1)
- Vaccination other than COVID-19 or FLU within 6 months prior to trial or expected during the trial period – with the exception of the routine vaccination campaign against Pneumococcus, or vaccines administered in the context of this trial
- Presence of any other significant findings that, in the opinion of the Investigator, would increase the risk of experiencing adverse outcomes from participating in the trial.
- Use of any investigational drug within 90 days prior to trial entry.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.