In short
Clinical trials investigating A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223) look at immune responses after influenza vaccination in health care personnel. The main goal is to measure antibody levels and other signs of humoral immunity (antibody-based immunity) against current, past, and circulating influenza strains.
Key points
- Clinical trials investigating A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223) focused on influenza and immunity against influenza. The main study was a Phase 3 interventional trial in health care personnel. Researchers measured antibody responses in blood samples taken before and after vaccination. The primary endpoint was humoral immunity to influenza virus strains in current, past, and circulating seasons. The trial was completed and enrolled 1500 people.
Trial overview
The available trial studied influenza and immunity against influenza in health care personnel. It was an interventional study, which means researchers gave a study product and then checked how the body responded.
The intervention listed in the trial was INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN given by intramuscular injection. The trial was completed and enrolled 1500 participants.
Who was studied
The target population was health care personnel. These are people who work in health care settings and may have a higher chance of meeting influenza at work.
No other participant details were provided in the trial data, so the main known group was health care personnel.
What was measured
The main outcome was humoral immunity, which means the antibody response in the blood. Researchers assessed antibodies against influenza virus strains included in the vaccines from the current and past seasons, as well as circulating influenza strains.
To measure this response, the study used serum samples and the hemagglutination inhibition (HI) test. The data also say that microneutralization or neutralization test (NT) may have been used.
Trial phase and design
This was a Phase 3 trial. Phase 3 studies are later-stage trials that usually include larger groups of people and help show how well a study product performs in a broader setting.
The study was interventional, not just observational, because it involved giving a vaccine product and then measuring the immune response. The enrollment number was 1500, which shows that this was a large study.
Endpoint details
The primary endpoint was the level of antibodies to influenza strains in the serum samples. The brief summary says the study aimed to assess the presence and titer, or amount, of antibodies against circulating influenza virus strains and vaccine strains from the current season.
In simple terms, the study asked whether vaccination led to a measurable immune response against flu strains that were already spreading and against strains included in the vaccine.
Key points for patients
This trial was not about treating a disease in one person, but about learning how well the immune system responds in a study group. The main focus was on blood test results after vaccination, not on symptoms or long-term outcomes.
For patients, the most important takeaway is that the trial looked at immune response to influenza in health care personnel, used a large Phase 3 design, and measured antibody levels before and after vaccination.