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A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)

Clinical trials investigating A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181) are looking at influenza immune responses after vaccination. The main goal is to measure safety-related study outcomes and, especially, how well the immune system responds in health care personnel and other eligible adults.

Table of contents

Overview of the trial

The trial record for A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181) describes a study of immune responses to influenza after vaccination.[1] The purpose was to assess antibodies against influenza virus strains from the current season, past seasons, and strains that were circulating in the community.[1]

Who was studied

The target population was health care personnel.[1] This means the study focused on people working in health care settings, rather than a broad general population.[1]

Study design and phase

This was an interventional study, meaning researchers gave a study intervention and then measured its effect.[1] The trial was in Phase 3, which is a later stage of testing in a larger group of participants.[1]

What the trial measured

The main outcome was humoral immunity, which is the antibody response found in blood serum samples.[1] Researchers assessed this using traditional hemagglutination inhibition testing, and they could also use microneutralization or neutralization tests.[1]

The brief summary also says the study aimed to measure the presence and titer, or amount, of antibodies before and after vaccination.[1] This helps show whether the immune response changed after the vaccine-related intervention.[1]

Trial status and size

The trial status is completed, so the planned study work has already finished.[1] The enrollment was 1,500 participants, which shows that this was a large study for measuring influenza immune responses.[1]

Key terms explained

Antibodies are proteins made by the immune system to recognize and help fight infection.[1] Serum is the liquid part of blood used for laboratory testing.[1] Titer means the amount of a substance, here the level of antibodies measured in the sample.[1]

Hemagglutination inhibition is a lab test used to see how well antibodies block influenza viruses from causing red blood cells to clump together.[1] Microneutralization and neutralization tests are other lab methods that check whether antibodies can stop the virus from infecting cells.[1]

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

FAQ

  • What is being studied in these trials? The trial is studying immune responses to influenza vaccination, including antibodies against influenza strains from the current and past seasons. It also looks at circulating influenza strains, which are the strains currently found in the community.
  • Who can take part? The study focuses on health care personnel. The trial data do not give more detailed eligibility rules, so participation details are limited to that target group.
  • What phase is this trial? This is a Phase 3 trial. Phase 3 studies usually test a vaccine or treatment in a larger group of people to better understand how well it performs.
  • What outcome is the trial measuring? The main outcome is humoral immunity, which means the antibody response in the blood. Researchers measure this with hemagglutination inhibition, and they may also use microneutralization or neutralization tests.
  • What is the status of the trial? The trial is completed. That means the planned study activities and data collection have already finished.

Sperimentazioni cliniche in corso su A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)

  • Studio sull’Immunità all’Influenza nei Professionisti Sanitari: Vaccino con Polysorbato 80, Sodio Citrato, Acido Citrico Anidro e Combinazione di Farmaci

    Arruolamento concluso

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Finlandia

Glossario

  • Influenza: A viral infection commonly called the flu. Trials in this data set focus on immune responses against influenza strains.
  • Immunity against influenza: The body's ability to defend itself against influenza infection, often measured by antibodies after vaccination.
  • Health care personnel: People who work in health care settings, such as hospitals or clinics. This is the main study population in the trial.
  • Phase 3: A later stage of clinical research with a larger group of participants. It helps researchers understand how a study intervention performs in real-world use.
  • Interventional study: A trial in which researchers give a study intervention and then measure its effects.
  • Humoral immunity: The antibody-based part of the immune response. In this trial, it is measured in blood serum samples.
  • Serum sample: A blood sample used for testing antibodies and other substances.
  • Hemagglutination inhibition (HI): A laboratory test used to measure antibodies against influenza viruses.
  • Microneutralization test (NT): A test that checks whether antibodies can block a virus from infecting cells.
  • Neutralization test: A laboratory method used to see if antibodies can stop a virus from causing infection in test systems.
  • Circulating influenza strains: Influenza strains that are currently spreading in the community.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sullimmunita-allinfluenza-nei-professionisti-sanitari-vaccino-con-polysorbato-80-sodio-citrato-acido-citrico-anidro-e-combinazione-di-farmaci/