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It is one of four influenza virus strains contained in Fluenz Tetra, a quadrivalent influenza vaccine. The other three strains in the vaccine are B/AUSTRIA/1359417/2021 - LIKE STRAIN, A/DARWIN/9/2021 (H3N2) - LIKE STRAIN, and A/VICTORIA/4897/2022 (H1N1)PDM09 - LIKE STRAIN.[1]
Fluenz Tetra is already authorised as a medicine in the European Union, with authorisation held by ASTRAZENECA AB. The vaccine is classified as a live attenuated influenza vaccine, meaning it contains weakened influenza viruses that cannot cause influenza in healthy people.[1]
As a live attenuated influenza vaccine, Fluenz Tetra is designed to mimic natural influenza infection. The weakened viruses in the nasal spray replicate in the cooler environment of the nasal passages, triggering the immune system to produce protective antibodies, including immunoglobulin A (IgA), directly at the site where influenza viruses typically enter the body. This local immune response in the nasal mucosa is what the clinical trial aims to characterise in detail.[1]
Fluenz Tetra is given as a nasal spray suspension. The vaccine is administered by intranasal use, with a dose of 0.2 millilitres sprayed into the nose. This is different from Vaxigrip Tetra, the comparison vaccine in the trial, which is given as an intramuscular injection of 0.5 millilitres.[1]
One Phase 3 trial (identifier 2024-513981-21-00) is investigating the immune response to the B/PHUKET/3073/2013 - Like Strain as part of Fluenz Tetra. The trial, titled "Characterization of antibodies in the nose after influenza vaccination", is currently authorised and plans to enrol 60 healthy participants.[1]
The trial compares intranasal vaccination with Fluenz Tetra against intramuscular vaccination with Vaxigrip Tetra. The main endpoint is the fold change in influenza-specific IgA levels in nasal fluid at day 21 after vaccination. The study aims to describe both the quantity (how much antibody is produced) and the quality (how well the antibody works) of the nasal antibody response.[1]
The Phase 3 trial enrols healthy individuals. The trial is interventional, meaning participants receive either the nasal spray vaccine or the intramuscular vaccine and are then followed over time to measure their antibody responses. Specific inclusion and exclusion criteria are available in the trial registry record.[1]
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