In short
Clinical trials are investigating A/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/NORWAY/16606/2021, MEDI 355293) to compare immune responses after influenza vaccination. The study looks at safety-related trial outcomes and how well the body makes antibodies in healthy people. It focuses on adults who can receive either an intranasal or intramuscular influenza vaccine.
Key points
- Clinical trials investigating A/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/NORWAY/16606/2021, MEDI 355293) are studying influenza vaccine responses in healthy individuals. The trial compares a nasal influenza vaccine with an injected influenza vaccine. It is a Phase 3 interventional study with 60 participants. The main outcome is the change in influenza-specific IgA in nasal fluid at day 21. The trial is authorised and focuses on how the immune response differs by route of vaccination.
Trial overview
This clinical trial is titled Characterization of antibodies in the nose after influenza vaccination and is listed as Authorised. It is an interventional study, which means researchers give the study vaccines and then measure the results.
The study is focused on healthy people and is designed to compare immune responses after influenza vaccination. The brief summary says the researchers want to study both quantitative and qualitative differences in antibody responses between intranasal and intramuscular vaccination.
Who can participate
The source data says the trial includes healthy individuals. No other participant details are provided in the trial data, such as age limits or medical history rules.
Study design and phase
This is a Phase 3 trial. Phase 3 studies are later-stage clinical trials that usually involve more people and help researchers learn more about how a study approach performs in a larger group.
The planned enrollment is 60 participants.
Main outcome measured
The main endpoint is the fold change in influenza-specific IgA levels in nasal fluid at day 21 after vaccination. Fold change means how much the level goes up or down compared with the earlier measurement.
IgA is a type of antibody, and nasal fluid is the liquid collected from the nose for testing. The trial uses this measure to compare the response after intranasal vaccination with the response after intramuscular vaccination.
Vaccines used in the study
The study compares Vaxigrip Tetra, given by intramuscular injection, with Fluenz Tetra nasal spray suspension, given by intranasal use. These are influenza vaccines used in the trial to study differences in antibody responses by route of vaccination.
What the study seeks to learn
The study aims to find out whether the nose-based vaccine and the injected vaccine lead to different antibody responses in healthy people. This is important because the nose is one of the first places where influenza can enter the body, so researchers are measuring antibodies there directly.
In simple terms, the trial is trying to learn which vaccination route gives a stronger local immune response in the nose. The data provided does not report results yet, only the study plan and main measurement.