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Influenza – Trials in Disease

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Clinical Trials for Influenza: Current Research and Opportunities

There are currently 25 ongoing clinical trials investigating various aspects of influenza prevention and treatment across Europe. These studies range from testing new vaccine formulations and administration methods to evaluating antiviral treatments in different age groups, from infants under 6 months to adults over 85 years old.

Clinical trial locations

Live Attenuated Influenza Vaccine (LAIV) and Immune Response in the Nasopharynx of Young Children with Influenza

This study examines how the immune system in the nose responds to the nasal spray vaccine in young children. The trial takes place in the Netherlands and focuses on children between 2 and 7 years of age who have not yet received the nasal spray vaccine this season.

Who can participate: Children aged 2-7 years whose parents have a home freezer to store samples and are willing to follow all study procedures. Parents must understand that the study involves two doses of the vaccine given about 4 weeks apart and that viral shedding will be monitored.

Who cannot participate: Children who have already received the nasal spray vaccine this season, those with weakened immune systems, severe asthma or active wheezing, allergies to vaccine components, those taking aspirin-like medications, pregnant individuals, or those with Guillain-Barré syndrome. Children with active respiratory illness, fever, close contact with severely immunocompromised individuals, recent vaccination within 4 weeks, or severe egg allergies are also excluded.

Study focus: The research aims to understand how the immune system in the nasal passages responds after receiving the nasal spray vaccine. Researchers will collect fluid samples from inside the nose using small absorptive devices at various timepoints to measure vaccine viruses and immune responses, including protective antibodies. Parents will complete questionnaires monitoring respiratory symptoms, and optional blood samples may be collected.

Treatment being tested: LAIV (Live Attenuated Influenza Vaccine) is a nasal spray containing weakened viruses that stimulate immune protection without causing illness. The study uses this vaccine to understand immune responses in the nose and throat area.

Study Comparing High-Dose and Standard-Dose Inactivated Influenza Vaccines in Adults with Blood Cancer

This Belgian trial compares two different strengths of vaccines in adults receiving treatment for blood cancers like multiple myeloma or B-cell malignancies. The study tests whether a higher dose vaccine produces a better immune response than the standard dose.

Who can participate: Adults aged 18 or older who are currently receiving treatment for multiple myeloma, B-cell malignancy (including those who received rituximab in the last 6 months), myeloid malignancy (excluding hydroxyurea or tyrosine kinase inhibitors), or standard chemotherapy. Participants must provide written informed consent.

Who cannot participate: Individuals without blood cancer, those outside the age range, people unwilling to be randomly assigned to either vaccine, those unable to give informed consent, or members of vulnerable populations.

Study focus: The trial evaluates whether the high-dose vaccine leads to better seroconversion rates (development of antibodies) compared to the standard dose. Researchers will monitor immune system activation and try to identify factors predicting better vaccine response. Safety monitoring includes tracking side effects and adverse events for six months following vaccination.

Treatments being tested: QIIV-HD (high-dose inactivated vaccine) and QIIV-SD (standard-dose inactivated vaccine). Both are made from killed viruses and cannot cause illness, designed to help build stronger defenses against the flu in patients with weakened immune systems.

Study of intravenous zanamivir safety and effectiveness in infants under 6 months of age with complicated influenza infection

This study in Italy and Spain focuses on treating very young infants hospitalized with severe influenza. The medication is given directly into the vein rather than orally, which is important for severely ill babies.

Who can participate: Babies under 6 months of age (corrected age for premature babies) who are hospitalized with confirmed influenza infection, weigh at least 1 kilogram, and have reached at least 28 weeks post-menstrual age if born prematurely. A parent or legal guardian must provide written consent, and the baby must have potential for improvement.

Who cannot participate: Babies with known allergies to zanamivir, those participating in other trials within 30 days, infants with severe medical conditions interfering with the study, those not hospitalized, babies over 6 months, those with severe kidney or liver problems, infants without confirmed infection, those with unsafe conditions for receiving the medication, infants whose parents cannot provide consent, babies with birth defects affecting medication function, or those currently using other antiviral medications.

Study focus: The research examines how zanamivir moves through very young bodies when given as single and multiple doses, checking safety and appropriate dosing. Healthcare teams monitor patients and collect blood samples to measure medication processing. Treatment lasts up to 10 days with a maximum daily dose of 24 mg per kilogram of body weight.

Treatment being tested: Intravenous zanamivir (brand name Dectova) is an antiviral medication that blocks a protein helping the virus spread. Given through an IV, it treats severe cases in patients unable to take oral medications, particularly important for very young hospitalized patients.

Study of oseltamivir and paracetamol blood levels in critically ill patients with severe influenza requiring mechanical ventilation

This French study examines how medicine levels in the blood affect recovery in severely ill patients needing breathing support. The research helps doctors understand if adjusting doses could improve treatment outcomes.

Who can participate: Adults aged 18 or older admitted to intensive care with confirmed severe infection requiring breathing support through a tube, with treatment started within 24 hours (no more than two doses given). Participants must have active social security coverage and provide written consent or have consent from a support person, family member, or through emergency procedures.

Who cannot participate: Patients not in ICU, those not requiring mechanical ventilation, individuals under 18, people without confirmed severe infection, patients unable to receive treatment, those unable to provide consent, patients intubated for more than 48 hours before enrollment, pregnant women (unless approved by healthcare provider), those with known medication allergies, and individuals in other interfering trials.

Study focus: The trial investigates how medicine amounts in blood affect recovery, measuring levels after 48 hours of treatment. Researchers track breathing support duration, collect throat swabs to check for virus, and monitor recovery over 90 days. Blood samples and paracetamol absorption tests assess medication absorption through the digestive system.

Treatment being tested: Oseltamivir is an antiviral medication that stops the virus from spreading inside the body. Converted to its active form (oseltamivir carboxylate), it reduces symptoms like fever, cough, and body aches, potentially shortening illness duration, particularly important for severe cases requiring intensive care.

Study on Antibody Responses in Healthy Individuals After Intranasal and Intramuscular Influenza Vaccination with Fluenz Tetra and Vaxigrip Tetra

This Netherlands study compares immune responses between nasal spray and injection vaccines. The research helps understand how each method establishes immunity against different strains.

Who can participate: Healthy individuals between 18 and 40 years old without significant health issues, especially no immune system problems.

Who cannot participate: People with ongoing illnesses or medical conditions, those outside the specific age range, and members of vulnerable populations (pregnant women, children, or those with certain disabilities).

Study focus: The trial examines immune responses in airways comparing nasal spray (containing weakened viruses) versus injection (containing purified antigens). Participants receive either vaccine or placebo, monitored over time for symptom changes and safety. Researchers collect samples measuring immune cells and antibodies to understand vaccine effectiveness in establishing immunity.

Treatments being tested: Nasal spray (intranasal) and injection (intramuscular) vaccines. The study examines both quantity and quality of antibodies produced, providing insights for improving prevention strategies.

Study on Aspirin and Pantoprazole for Reducing Heart Attack Risk in Hospitalized Pneumonia Patients

This Netherlands study evaluates whether adding aspirin to usual pneumonia treatment reduces heart problem risks, specifically acute coronary syndrome including heart attacks, in hospitalized patients.

Who can participate: Adults 40 years or older with community-acquired pneumonia (not hospital-acquired) confirmed by symptoms and chest X-ray showing new lung infection. Must have moderate to severe pneumonia (CURB-65 score of 2 or higher or PSI score of 3 or higher) and be admitted to the hospital.

Who cannot participate: Patients who have had heart attacks or currently have pneumonia.

Study focus: The trial determines if aspirin can provide additional benefits preventing heart-related complications in pneumonia patients. Participants receive either aspirin or placebo along with pantoprazole (protecting stomach lining). The 90-day treatment period includes 180-day monitoring for heart-related events and other outcomes, ensuring safety and well-being throughout.

Treatment being tested: Aspirin is being studied to see if it helps prevent heart problems in pneumonia patients. Researchers investigate whether taking aspirin with antibiotics can lower chances of heart attacks or other heart issues during hospitalization.

Study on Baloxavir Marboxil for Children with Influenza

This trial in Bulgaria, Poland, and Spain studies how the virus responds to Baloxavir Marboxil treatment in children, specifically checking if the virus becomes resistant to the medication.

Who can participate: Children with confirmed infection (positive test within 24 hours before screening), negative SARS-CoV-2 test within 48 hours before screening, symptom onset within 48 hours before examinations. Parents/caregivers must understand the study, follow procedures, and sign written agreement. Both male and female children can participate, including vulnerable populations.

Who cannot participate: Children with known allergies to medication or ingredients, currently in another trial or within 30 days, those with severe liver or kidney disease, pregnant or breastfeeding individuals, those with compromised immune systems, children receiving live vaccines within 4 weeks, or those with conditions making participation unsafe as determined by study doctors.

Study focus: The research monitors children diagnosed with flu, taking samples at different times to check for virus changes and resistance development. The trial involves several visits collecting samples to monitor the virus and medication side effects, gathering information on virus response to Baloxavir Marboxil and ensuring treatment safety and effectiveness.

Treatment being tested: Baloxavir Marboxil inhibits virus replication, helping reduce severity and duration of symptoms. Provided as granules mixed with liquid (oral suspension) for easier administration to children.

Study on Immune Responses to Avian Influenza Vaccine with A/Turkey/Turkey/1/05 (H5N1)-Like Strain in Patients with Avian and Seasonal Influenza

This Finnish study evaluates immune responses to vaccines for avian influenza (bird flu) and seasonal flu, focusing on the H5N1 2.3.4.4b clade of avian virus.

Who can participate: Adults aged 18-65 years in the target group planning to receive at least one avian vaccine dose, able to understand written and spoken information, providing written consent, with a Finnish home address, able to provide samples 3 weeks after each dose and preferably participate in 6 and 12-month follow-ups. Pregnant and breastfeeding women can participate.

Who cannot participate: People with severe allergic reactions to vaccine ingredients, history of Guillain-Barré syndrome, current fever or active infection, pregnant women, those receiving other vaccines within 30 days, individuals taking immune-weakening medications, participants in other trials within 30 days, or those with drug or alcohol abuse history in the past year.

Study focus: The trial evaluates immune system responses to vaccines by measuring antibody levels and specific immune cell activation. Participants receive vaccines as injections, with immune response monitored at various intervals. The research provides insights into vaccine effectiveness in preventing infections.

Treatments being tested: VaxigripTetra (quadrivalent vaccine protecting against four viruses) and Zoonotic Influenza Vaccine Seqirus (targeting H5N1 avian strain). VaxigripTetra is given into muscle or under skin, while Seqirus is given directly into muscle.

Study on the Effectiveness and Safety of OVX836 Vaccine for Preventing Influenza in Healthy Adults Aged 18-59

This trial in Finland and France tests a new vaccine called OVX836 in healthy adults aged 18-59, comparing effectiveness and safety to placebo.

Who can participate: Healthy males and females aged 18-59 years providing written informed consent, meeting reproductive criteria, reliable and willing to be available throughout study duration, able to complete electronic diary and patient-reported outcomes, socially active (living with family/household members or frequent social contacts), able to read and sign information sheets and consent forms.

Who cannot participate: People outside age range, those with known vaccine component allergies, individuals receiving other vaccines within certain periods, those with severe allergic reaction history to any vaccine, people with weakened immune systems, those currently experiencing fever or acute illness, pregnant or breastfeeding individuals, recent clinical trial participants, those with drug or alcohol abuse history, or people with other medical conditions making participation unsafe as determined by study doctors.

Study focus: The research determines vaccine effectiveness in preventing Type A flu confirmed by RT-PCR test, examining body responses and checking side effects. Monitoring includes first 7 days after vaccination for reactions, 29 days for unexpected events, and throughout study duration for serious events and respiratory infections.

Treatment being tested: OVX836 is an experimental vaccine given as a single muscle shot, designed to protect against Type A flu, specifically targeting influenza viruses to prevent symptoms.

Study on the Effectiveness of an MF59-Adjuvanted Influenza Vaccine Compared to a Non-Adjuvanted Vaccine in Adults Aged 65 and Older

This large multinational study across 10 European countries compares vaccines with and without MF59 adjuvant (a substance boosting immune response) in older adults. The trial evaluates effectiveness and safety throughout the season.

Who can participate: Adults 65 years or older on vaccination day who voluntarily give written informed consent and can follow study procedures including attending follow-up appointments.

Who cannot participate: Participants with severe allergies (especially to vaccine components), severe reaction history to previous vaccines, acute illness or fever at vaccination time, those receiving immune-affecting treatments (chemotherapy or high-dose steroids), people with uncontrolled chronic diseases (diabetes or heart disease), pregnant individuals or those planning pregnancy during study, participants in other trials within 30 days, those receiving other vaccines within 6 months, or people with conditions making participation unsafe or affecting results as determined by study doctors.

Study focus: The study compares MF59-adjuvanted vaccine effectiveness versus non-adjuvanted vaccine in reducing hospitalization risk due to flu or pneumonia. Monitoring occurs from 14 days after vaccination throughout season, tracking hospitalizations for flu, pneumonia, cardio-respiratory diseases, all-cause hospitalizations, and mortality.

Treatments being tested: MF59-adjuvanted vaccine (containing adjuvant boosting immune response, making it more effective especially for older adults) and non-adjuvanted vaccine (standard shot without adjuvant). Both protect against four strains.

Study on the Effectiveness of High-Dose vs. Standard-Dose Quadrivalent Influenza Vaccine in Preventing Flu in Adults Aged 65-79 in Galicia, Spain

This Spanish study in Galicia compares high-dose versus standard-dose vaccines in adults aged 65-79 years, focusing on hospitalization prevention.

Who can participate: Adults aged 65-79 years living in the community, not eligible for high-dose vaccine as regular care, who have signed and dated informed consent forms.

Who cannot participate: People outside 65-79 age range or members of vulnerable populations.

Study focus: The trial evaluates high-dose vaccine effectiveness compared to standard-dose in reducing hospitalization risk due to flu or pneumonia. Participants are randomly assigned to receive either version (intramuscular injection from pre-filled syringe). Monitoring occurs throughout study assessing hospitalization occurrences for flu, pneumonia, cardio-respiratory diseases, all-cause hospitalizations, and mortality.

Treatments being tested: Quadrivalent Influenza Vaccine in two forms: high-dose and standard-dose versions, both protecting against four virus strains. The goal is determining which version offers better protection for older adults against serious complications.

Summary

The 25 ongoing clinical trials represent a comprehensive effort to improve prevention and treatment across all age groups, from infants under 6 months to adults over 85 years old. The research spans 13 European countries, with particularly strong concentration in Belgium (8 trials), Spain (7 trials), Finland (6 trials), and the Netherlands (5 trials).

Several notable themes emerge from these studies. There is significant focus on optimizing vaccine dosing strategies for older adults, with multiple trials comparing high-dose versus standard-dose vaccines in people aged 65 and older. This reflects the recognition that older adults often have weaker immune responses and face higher risks from complications.

The research also explores innovative vaccine technologies, including mRNA-based vaccines and novel adjuvant formulations, alongside traditional approaches. Several studies examine different administration routes, comparing nasal spray vaccines with injectable versions to understand which might provide better protection.

Vulnerable populations receive special attention, with dedicated studies for cancer patients undergoing treatment, critically ill patients requiring intensive care, and very young infants. The antiviral medication studies, particularly those examining zanamivir and oseltamivir in severely ill patients, address important treatment gaps for those most at risk of serious complications.

The multinational nature of many trials, particularly the large vaccine effectiveness studies spanning multiple European countries, will provide robust data applicable across diverse populations. This coordinated research effort promises to advance understanding of prevention and treatment, ultimately helping protect people across all age groups from this common but potentially serious illness.

Ongoing Clinical Trials on Influenza

  • Study of intravenous zanamivir safety and effectiveness in infants under 6 months of age with complicated influenza infection

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study on Aspirin and Pantoprazole for Reducing Heart Attack Risk in Hospitalized Pneumonia Patients

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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