In short
Clinical trials investigating INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) are studying influenza vaccine research in different groups of people. These studies look at safety, immune response, and how well vaccines help prevent influenza-related illness. The target groups include healthy adults, older adults, and patients with hematological cancer.
Key points
- Clinical trials investigating INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) are focused on influenza vaccine research. The studies include Phase 1/2 and Phase 3 trials. They involve healthy volunteers, older adults, adults aged 65 to 79 years, and patients treated for hematological cancer. The main goals are to study safety, reactogenicity, immune response, and vaccine effectiveness. Some trials also measure hospitalizations for influenza or pneumonia and compare high-dose with standard-dose vaccines. One study also looks at giving an influenza vaccine together with another vaccine in older adults.
Overview of the trials
The clinical trials for INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) are vaccine studies focused on preventing influenza and related illness. The trial data show research on vaccine effectiveness, immune response, safety, and reactogenicity, which means short-term reactions after vaccination. Some studies compare high-dose and standard-dose influenza vaccines, while others test vaccine use in older adults or in patients with hematological cancer.
Who the trials include
These trials include several patient groups, so the study results can apply to different levels of risk and immune health. One large Phase 3 study includes adults aged 65 to 79 years in Galicia, Spain, and looks at prevention of influenza infection. Another Phase 3 study includes adults treated for hematological cancer, which means cancers of the blood or bone marrow, and compares two influenza vaccine doses. A Phase 1/2 study includes healthy younger and older adults, and one Phase 3 study includes adults aged 65 years or older.
Trial designs and phases
The trial set includes both Phase 1/2 and Phase 3 studies.
Phase 1/2 research usually looks first at safety and early immune response in a smaller or mixed group of participants. Phase 3 studies are larger and are used to compare how well different vaccine strategies work and how safe they are in real-world-like groups.
One study is a randomized trial, which means participants are assigned by chance to different vaccine groups. One study is also described as double-blind, meaning the people in the study do not know which treatment they receive, helping reduce bias in the results.
What the trials measure
The main outcomes are linked to both clinical events and immune response.
- Hospitalization due to influenza or pneumonia: one Phase 3 study uses this combined outcome to see whether high-dose vaccine lowers the risk of serious illness.
- Seroconversion: one cancer study measures whether participants develop a clear blood antibody response after vaccination.
- Hemagglutination inhibition (HI) titers: one study measures antibody levels against each influenza strain 29 days after vaccination, which helps show immune response.
- Safety and reactogenicity: one Phase 1/2 study tracks local and general symptoms, unwanted events, serious adverse events, and medically attended events over time.
- Laboratory changes: the Phase 1 part of the study also checks whether blood test values change from normal to abnormal after vaccination.
Key trials in this set
The largest Phase 3 study in adults aged 65 to 79 years compares high-dose quadrivalent influenza vaccine with standard-dose quadrivalent influenza vaccine and looks at hospitalization for influenza or pneumonia as the main endpoint. Its enrollment is 114,011, which makes it the largest study in the provided data.
The Flu-Hemato-Rando study is a Phase 3 randomized single-blind trial in adults treated for hematological cancer. It compares high-dose and standard-dose inactivated influenza vaccine and also includes a systems biology part, which means detailed study of how the body responds at a biological level.
Another Phase 3 study in adults aged 65 years or older tests whether giving ExPEC9V together with a high-dose quadrivalent influenza vaccine affects immune response, safety, and reactogenicity. This study is useful because it looks at vaccine co-administration, meaning two vaccines are given together.
The Phase 1/2 study in healthy younger and older adults aims to find and confirm the dose and to assess safety, reactogenicity, and immune response. It also measures several antibody results over time, including geometric mean titer and seroconversion rate.
Simple explanation of important terms
Enrollment means the number of people planned or included in a study.
Interventional study means the researchers give a vaccine or another study treatment and then measure the results.
Primary endpoint means the main result the researchers want to measure.
Humoral immune response means the body’s antibody response in the blood after vaccination.
Adverse event means any unwanted medical problem seen during a study, whether or not it is caused by the vaccine.