Table of Contents
- Trial overview
- Who participates in these studies
- What the trials measure
- Trial phases and study design
- Main trials in the data
- Patient glossary
Trial overview
The trials in this data set study INFLUENZA A VIRUS SUBTYPE H3N2 HAEMAGGLUTININ, RECOMBINANT as part of influenza vaccine research in adults.[1] The studies focus on whether the vaccine helps the body make antibodies and whether it is safe and well tolerated.[1] The research includes both Phase 2 and Phase 3 studies.[1][2]
Who participates in these studies
One Phase 2 study includes adults 18 years of age and older with influenza, human.[1] Another Phase 2 study also includes adults 18 years and older, and it compares different vaccine groups.[3] The Phase 3 study focuses on adults 50 years and older, including healthy people and people with stable comorbidities, which means long-term health conditions that do not change quickly.[2]
What the trials measure
The main immune measures are antibody titer, fold increase in antibody levels, seroconversion, and seroprotection.[1][3] These measures show whether the vaccine causes the body to build a response against influenza.[1][3] The studies also measure safety outcomes such as solicited administration site or systemic events, unsolicited adverse events, serious adverse events, adverse events of special interest, medically attended adverse events, and laboratory abnormalities.[1][3]
The Phase 3 study uses hemagglutination inhibition (HI) assay results to compare immune responses across vaccine lots and between vaccines.[2] It reports outcomes such as geometric mean titers and seroconversion rates at Day 29.[2] This helps researchers compare how strong the immune response is after vaccination.[2]
Trial phases and study design
The Phase 2 studies are interventional trials, which means researchers assign study interventions and then measure the results.[1][3] These studies mainly look at humoral immune response, which means the antibody response in the blood, and safety/reactogenicity, which means how the body reacts after vaccination.[1][3] The Phase 3 study is designed to first show lot-to-lot consistency and then compare immunological noninferiority against other influenza vaccines.[2]
Noninferiority means the study is checking whether one vaccine performs at least as well as another by a pre-set rule, rather than trying to prove it is better.[2] Lot-to-lot consistency means different production batches of the same vaccine are compared to see if they give similar immune responses.[2]
Main trials in the data
NCT07204964 is a Phase 2 study in adults 18 years and older with influenza, human.[1] It is authorised and has an enrollment of 960 participants.[1] The study measures antibody response at Day 29 and safety events over days to months after vaccination.[1]
2023-503763-42-00, called the Celljuvant study, is a Phase 3 study in adults 50 years and older.[2] It is completed and enrolled 6,300 participants.[2] The study compares three lots of the vaccine and then compares the vaccine with other influenza vaccines using HI assay results at Day 29.[2]
2025-522278-35-00 is another Phase 2 study in adults 18 years and older with influenza, human.[3] It is completed and enrolled 770 participants.[3] The study looks at immune response and safety, including antibody titer, seroconversion, seroprotection, and different safety events.[3]
Patient glossary
Adjuvanted vaccine means a vaccine that includes an added ingredient to help improve the immune response.[2] Intramuscular use means the vaccine is given into a muscle.[1][3] Injection and injection site events refer to the shot and any local reactions where it is given.[2][3]
Humoral immune response means the antibody response in the blood.[1][3] Safety and reactogenicity profile means the pattern of side effects and body reactions seen after the study intervention.[1][3] Stable comorbidities means other health problems that are not changing quickly.[2]
