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A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223)

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.

Table of contents

Trial overview

The available trial studied influenza and immunity against influenza in health care personnel.[1] It was an interventional study, which means researchers gave a study product and then checked how the body responded.[1]

The intervention listed in the trial was INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN given by intramuscular injection.[1] The trial was completed and enrolled 1500 participants.[1]

Who was studied

The target population was health care personnel.[1] 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.[1]

What was measured

The main outcome was humoral immunity, which means the antibody response in the blood.[1] Researchers assessed antibodies against influenza virus strains included in the vaccines from the current and past seasons, as well as circulating influenza strains.[1]

To measure this response, the study used serum samples and the hemagglutination inhibition (HI) test.[1] The data also say that microneutralization or neutralization test (NT) may have been used.[1]

Trial phase and design

This was a Phase 3 trial.[1] 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.[1] The enrollment number was 1500, which shows that this was a large study.[1]

Endpoint details

The primary endpoint was the level of antibodies to influenza strains in the serum samples.[1] 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.[1]

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.[1]

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.[1] The main focus was on blood test results after vaccination, not on symptoms or long-term outcomes.[1]

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.[1]

Trial ID Phase Condition studied Status Enrollment
NCT03323112 Phase 3 Influenza, immunity against influenza Completed 1500

FAQ

  • Who was studied in these trials? The trial studied health care personnel. This means people working in health care settings who may be exposed to influenza at work.
  • What was being measured in the trial? The trial measured humoral immunity, or antibody response, to influenza virus strains. It looked at blood samples taken before and after vaccination.
  • What phase was the trial? This was a Phase 3 trial. Phase 3 trials usually involve larger groups and help assess how well a vaccine-related approach performs in a real study setting.
  • What condition was being studied? The trial focused on influenza and immunity against influenza. It looked at protection-related immune responses to vaccine strains and circulating strains.
  • What kind of study was it? It was an interventional study, which means researchers gave a study treatment and then measured the body’s response. In this trial, the intervention was an influenza vaccine product.

Ongoing Clinical Trials on A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223)

  • Study on Immune Responses to Influenza Vaccines in Health Care Workers Using Polysorbate 80, Sodium Citrate, and Citric Acid Anhydrous

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

Glossary

  • Influenza: A viral infection often called the flu. It can spread easily from person to person and may cause fever, cough, body aches, and tiredness.
  • Immunity: The body’s ability to protect itself from infection. In this trial, researchers looked at immune protection against influenza.
  • Humoral immunity: A type of immunity that uses antibodies in the blood to fight infection. This trial measured how strongly the body made these antibodies.
  • Antibody: A protein made by the immune system that can recognize and help fight a virus or other germ.
  • Serum: The liquid part of blood used for testing. Researchers tested serum samples before and after vaccination.
  • Pre-vaccination: Before a vaccine is given. These samples show the starting immune level.
  • Post-vaccination: After a vaccine is given. These samples show how the immune system responded.
  • Hemagglutination inhibition (HI): A lab test used to measure antibodies against influenza. It helps show whether the blood can block the virus from attaching to cells.
  • Microneutralization test (NT): A lab test that checks whether antibodies can stop a virus from infecting cells. It may be used in this study.
  • Phase 3: A later stage of clinical research that usually studies larger groups of people to better understand how a treatment or vaccine-related product performs.

References