Study of a Combination SARS-CoV-2 Recombinant Spike and High-Dose Inactivated Influenza Vaccine with Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older
EU CTIS ID: 2026-526221-18-00
What this study is testing
To demonstrate the non-inferiority in influenza-specific immune responses between the combination vaccine and the comparator arm for each of the 3 influenza vaccine strains, in a subset of participants To demonstrate the non-inferiority in SARS-CoV-2 variant-specific immune responses between the combination vaccine and the comparator arm, in a subset of participants
- Therapeutic confirmatory (Phase III)
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
- Inclusion criteria to be checked at Screening Visit: Aged 60 years or older on the day of inclusion
- Inclusion criteria to be checked at Visit 1 (D01): Able to attend all scheduled visits and to comply with all study procedures
- Inclusion criteria to be checked at Visit 1 (D01): Participant must be able to receive an injection in the deltoid muscle of both arms
- Inclusion criteria to be checked at Visit 1 (D01): Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine
- Inclusion criteria to be checked at Screening Visit: Informed consent form has been signed and dated
- Inclusion criteria to be checked at Screening Visit: Able to attend all scheduled visits and to comply with all study procedures
You likely can't join if
- Known/suspected immunodeficiency; immunosuppressive therapy in past 6 months; long-term systemic corticosteroids
- Prior history of myocarditis, pericarditis, or myopericarditis
- Any vaccine given within 4 weeks before or within 4 weeks after study intervention
- Previous vaccination against influenza (in the previous 6 months before study intervention) with an investigational or marketed vaccine OR history of influenza infection in the previous 6 months
- Previous vaccination against COVID-19 (in the previous 6 months before study intervention) with an investigational or marketed vaccine OR history of COVID-19 infection in the previous 6 months
- Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
See the full eligibility criteria
- Inclusion criteria to be checked at Screening Visit: Aged 60 years or older on the day of inclusion
- Inclusion criteria to be checked at Visit 1 (D01): Able to attend all scheduled visits and to comply with all study procedures
- Inclusion criteria to be checked at Visit 1 (D01): Participant must be able to receive an injection in the deltoid muscle of both arms
- Inclusion criteria to be checked at Visit 1 (D01): Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine
- Inclusion criteria to be checked at Screening Visit: Informed consent form has been signed and dated
- Inclusion criteria to be checked at Screening Visit: Able to attend all scheduled visits and to comply with all study procedures
- Inclusion criteria to be checked at Screening Visit: Participant must be able to receive an injection in the deltoid muscle of both arms
- Inclusion criteria to be checked at Screening Visit: Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine
- Inclusion criteria to be checked at Visit 1 (D01): Aged 60 years or older on the day of inclusion
- Inclusion criteria to be checked at Visit 1 (D01): Participants who are healthy or with pre-existing stable condition, as determined by medical evaluation including medical history and physical examination
- Inclusion criteria to be checked at Visit 1 (D01): Non-childbearing potential (i.e., post-menopausal for at least 1 year or surgically sterile)
- Inclusion criteria to be checked at Visit 1 (D01): lnformed consent form has been signed and dated
- Known/suspected immunodeficiency; immunosuppressive therapy in past 6 months; long-term systemic corticosteroids
- Prior history of myocarditis, pericarditis, or myopericarditis
- Any vaccine given within 4 weeks before or within 4 weeks after study intervention
- Previous vaccination against influenza (in the previous 6 months before study intervention) with an investigational or marketed vaccine OR history of influenza infection in the previous 6 months
- Previous vaccination against COVID-19 (in the previous 6 months before study intervention) with an investigational or marketed vaccine OR history of COVID-19 infection in the previous 6 months
- Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
- Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily
- Is an investigator, investigator/study center employee, or immediate family member (parent, spouse, natural/adopted child) of the investigator/employee with direct involvement in the study
- Known systemic hypersensitivity to any study intervention components or history of life-threatening reaction to study interventions or products with the same substances
- Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator’s judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator’s judgment
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Moderate/severe acute illness/infection (per investigator judgment)/fever (≥38.0°C [≥100.4°F]) on study intervention day. Include participant only after the condition or fever has resolved.
- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
- History of serious adverse reaction to any influenza or COVID-19 vaccines per investigator’s judgment
- Personal or family history of Guillain-Barré syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Poland
- Portugal
- France
- Germany
- Honduras
- Colombia
- United Kingdom
- Costa Rica
- Mexico
- Panama
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, but 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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poland; Portugal; France; Germany; Honduras; Colombia and 4 more locations. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.