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VAXXAIR TRIAL: In-depth Immunological Analysis of Airway Immunity following Nasal Live Attenuated and Intramuscular Influenza Vaccine A randomized controlled trial
EU CTIS ID: 2023-506166-31-01
What this study is testing
To understand and determine immunological and airway epithelial factors for whether a nasally administered LAIV vaccination is effective in establishing immunity towards specific H/N influenza subtypes compared to quadrivalent IIV.
- Therapeutic use (Phase IV)
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
- Age ≥ 20-40 years
- Participants who have not received any influenza as per medical history and documented in DDV (electronic vaccine registry)
You likely can't join if
- Laboratory-confirmed influenza infection during the past year documented by a positive PCR test in the Danish Microbiological database
- Use of immunosuppressive drugs within the past 6 months or who are currently using them
- Known immunodeficiency disorders [any diagnosis that would qualify to an ICD-10 diagnosis in the categories DD80-DD89 (except DD86)
- HIV, HBV, HCV laboatory confirm active infection at screening visit
- Have an acute illness, including an oral temperature ≥ 38°C, within 3 days prior to vaccination
- 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
See the full eligibility criteria
- Age ≥ 20-40 years
- Participants who have not received any influenza as per medical history and documented in DDV (electronic vaccine registry)
- Laboratory-confirmed influenza infection during the past year documented by a positive PCR test in the Danish Microbiological database
- Use of immunosuppressive drugs within the past 6 months or who are currently using them
- Known immunodeficiency disorders [any diagnosis that would qualify to an ICD-10 diagnosis in the categories DD80-DD89 (except DD86)
- HIV, HBV, HCV laboatory confirm active infection at screening visit
- Have an acute illness, including an oral temperature ≥ 38°C, within 3 days prior to vaccination
- 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
- Any known malignant neoplasm within 5 years (except basal carcinoma of the skin)
- Severe mental illness or linguistic issues which significantly impedes cooperation
- Inability to provide written informed consent
- Previous medical history, evidence of an intercurrent illness or any condition that, in the opinion of the investigator, would interfere with evaluation of the study vaccine products or interpretation of subject safety or that may compromise the safety of the subject in the study.
- Total IgG levels < 6.1 g/L obtaining at screening visit
- Influenza specific IgA in upper quartile in mucosa. Upper quartile will be defined “real time” in the screening population
- Active smoker
- BMI >35
- Charlson (score > 0)
- Women of childbearing potential not using safe contraception, or who are pregnant, or breast-feeding
- Any allergies to components of or contraindication for Vaxigriptetra® or Flumist®
- Participants who have experienced severe adverse reactions to previous influenza vaccinations or components of the vaccines, including allergy to egg
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, 18-64 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.