Nasal spray vs. needle: which flu vaccine works better?
NCT ID NCT05921448
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two flu vaccines: a nasal spray and a standard shot. Researchers will measure immune responses in the nose and blood of 60 healthy adults aged 18-49. The goal is to understand how each vaccine triggers protection and find ways to improve future flu vaccines.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Influenza vaccines (nasal spray and injection)
- What this could lead to
- If successful, this study could reveal which flu vaccine type triggers stronger nasal immunity, potentially leading to more effective vaccines.
- What could go wrong
- This is a very early, small study (60 people) focused on immune markers, not on preventing flu. Results may not apply to the general population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 49 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy individuals (Charlson´s co-morbidity index :0, and investigator judged as healthy) 2. Age: 18-49 years 3. Total IgG levels in normal range (discretion of investigator according to local lab) 4. Total IgA levels (discretion of investigator according to local lab) 5. Undetectable HAI titres to the H3N2 component of the vaccines\* 6. Normal CD4+ and CD8+ T-cell and normal B-cell counts 7. Reference levels from ISO-15189 accredited T-, B- and NK-cell count routine analyses will be applied. * If \<20% of the first 100 screened persons apply to this criterion, this will be changed to a specific cut off based on the lowest quartile level of HAI titres to the H3N2 component of these 100 screened persons. Exclusion Criteria: 1. Laboratory-confirmed influenza infection during the past year documented by a positive PCR test in the Danish Microbiological database or anamnestic reported influenza infection in the same period 2. Active smoker 3. BMI \> 35 kg/m2 4. Women of childbearing potential not using safe contraception, or who are pregnant, or breast-feeding 5. Any allergies to components of or contraindication for Vaxigriptetra® or Flumist® incl. previous severe adverse reactions to influenza vaccinations or components of the vaccines 6. Use of immunosuppressive drugs\* within the past 6 months or who are currently using them 7. HIV, HBV, HCV laboratory confirmed active infection at screening visit 8. Have an acute illness, including an oral temperature ≥ 38°C, within 3 days prior to vaccination 9. Have received any vaccines, including live-attenuated vaccines within 4 weeks before inclusion, or plan receipt of such vaccines within 30 days following the inclusion 10. Any known malignant neoplasm within 5 years (except basal carcinoma of the skin). 11. Severe mental illness or linguistic issues which significantly impedes cooperation 12. Inability to provide written informed consent * defined as: Azathioprin, methotrexate, cyclophosphamide, basiliximab, belimumab, anifrolumab, alemtuzumab, rituximab, mycophenolat, calcineurin inhibitors (ciclosporin, voclosporin and tacrolimus), mTOR inhibitors (everolimus and sirolimus), prednisolone (or any corticosteroid in doses above the equivalent of 5 mg prednisolone), TNF-α inhibitors (such as infliximab), anti-thymocyte globulin.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Rigshospitalet, Denmark
Copenhagen, Copenhagen, 2100, Denmark
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Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital
Gentofte Municipality, Copenhagen, 2900, Denmark
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Diagnostic Immunology, Department of Clinical Immunology, Rigshospitalet, Denmark
Copenhagen, Copenhagen, 2100, Denmark
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Imperial College
London, W12 0NN, United Kingdom
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Institute for Immunology and Microbiology (ISIM), Panum Institute, University of Copenhagen
Copenhagen, Copenhagen, 2100, Denmark
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National Influenza Center for WHO at Statens Serum Institut (SSI)
Copenhagen, 2300, Denmark
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Technical University of Denmark (DTU)
Kongens Lyngby, 2800, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can mRNA technology outsmart the flu in older adults?
- One shot, two protections? a new vaccine aims to tackle flu and COVID together
- Can a lab-made flu vaccine outperform the traditional egg-based shot?
- Bedside flu shot for heart patients: a simple strategy to save lives?
- New hope for tiniest flu patients: IV zanamivir tested in infants under 6 months