Table of contents
- Trial overview
- Who can participate
- Study design and phase
- Main outcome measured
- Vaccines used in the study
- What the study seeks to learn
Trial overview
This clinical trial is titled Characterization of antibodies in the nose after influenza vaccination and is listed as Authorised.[1] It is an interventional study, which means researchers give the study vaccines and then measure the results.[1]
The study is focused on healthy people and is designed to compare immune responses after influenza vaccination.[1] The brief summary says the researchers want to study both quantitative and qualitative differences in antibody responses between intranasal and intramuscular vaccination.[1]
Who can participate
The source data says the trial includes healthy individuals.[1] No other participant details are provided in the trial data, such as age limits or medical history rules.[1]
Study design and phase
This is a Phase 3 trial.[1] 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.[1]
The planned enrollment is 60 participants.[1]
Main outcome measured
The main endpoint is the fold change in influenza-specific IgA levels in nasal fluid at day 21 after vaccination.[1] Fold change means how much the level goes up or down compared with the earlier measurement.[1]
IgA is a type of antibody, and nasal fluid is the liquid collected from the nose for testing.[1] The trial uses this measure to compare the response after intranasal vaccination with the response after intramuscular vaccination.[1]
Vaccines used in the study
The study compares Vaxigrip Tetra, given by intramuscular injection, with Fluenz Tetra nasal spray suspension, given by intranasal use.[1] These are influenza vaccines used in the trial to study differences in antibody responses by route of vaccination.[1]
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.[1] 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.[1]
In simple terms, the trial is trying to learn which vaccination route gives a stronger local immune response in the nose.[1] The data provided does not report results yet, only the study plan and main measurement.[1]
