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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) are studying influenza immune responses after vaccination. The available trial focuses on health care personnel and evaluates antibody response against influenza strains from current, past, and circulating seasons. The main aim is to measure immunity and compare pre- and post-vaccination blood samples.

Table of contents

Trial overview

This clinical research studied A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223) in the setting of influenza immune response after vaccination.[1] The trial focused on whether blood samples showed antibodies against influenza strains from the current season, past seasons, and strains that were circulating in the community.[1]

The study title was Immune responses in health care personnel, which shows that the main purpose was to observe how vaccination-related immunity appeared in this group.[1] The brief summary also says the study aimed to assess the presence and titer of antibodies in pre- and post-vaccination serum samples.[1]

Who participated

The target population was health care personnel.[1] This means the study involved people working in health care settings, a group that may have regular exposure to influenza.

The trial enrolled 1500 participants, which is a large group for a clinical study.[1] A larger number of participants helps researchers observe immune response patterns in more people.

What was measured

The main outcome was humoral immunity to influenza virus strains included in the vaccines of the current and past seasons, as well as circulating influenza strains.[1] Humoral immunity means the antibody response in the blood.

Researchers used serum samples and measured antibodies with hemagglutination inhibition (HI) testing.[1] The trial also states that microneutralization or neutralization test (NT) could be used.[1] These are laboratory tests that help show whether antibodies can block the virus.

Study phase and design

The trial was a Phase 3 study.[1] Phase 3 studies usually involve larger groups and help researchers understand how a study intervention performs in a broader population.

The study type was interventional, meaning participants received a planned intervention so researchers could measure the effect.[1] In this trial, the intervention listed was Influenza, Inactivated, Split Virus or Surface Antigen, given as 0.5 ml intramuscularly.[1]

Trial status and size

The trial status was completed, which means the planned study work was finished.[1] Completion is important because it means the data collection phase ended and the results could be reviewed.

With 1500 enrolled participants, this was a substantial study for evaluating influenza-related immune responses in health care personnel.[1]

Key medical terms

Serum sample means a blood sample used for laboratory testing.[1] In this trial, researchers compared samples taken before and after vaccination.

Antibody titer means the amount of antibodies found in the blood.[1] Higher titers can suggest a stronger immune response.

Circulating influenza strains are flu strains currently spreading in the community.[1] The study checked whether the immune response covered these strains as well as vaccine strains from different seasons.

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

FAQ

  • Who took part in the clinical trial? The trial studied health care personnel. This means people working in health care settings who were included to see how their immune response changed after vaccination.
  • What was the trial studying? The trial studied immune responses to influenza after vaccination. It looked at antibodies in blood samples against influenza strains from the current season, past seasons, and circulating strains.
  • What phase was the trial? The trial was Phase 3. Phase 3 studies usually involve larger groups and help assess how well a vaccine-related intervention performs in a broader population.
  • What was the main outcome measured? The main outcome was humoral immunity, which means the antibody response in the blood. The study used hemagglutination inhibition, and sometimes microneutralization or neutralization tests, to measure this response.
  • What was the status of the trial? The trial was completed. This means the planned study activities were finished and the results could be analyzed.

Sperimentazioni cliniche in corso su A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223)

  • 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. It can spread from person to person and is often studied in vaccine trials.
  • Immunity against influenza: The body’s protection against influenza infection. In this trial, it was measured by checking antibody levels in blood.
  • Health care personnel: People who work in health care settings, such as hospitals or clinics. They are often included in influenza studies because they may be exposed to flu viruses.
  • Phase 3: A late stage of clinical research that usually involves a larger number of participants. It helps researchers study how well an intervention works in a broader group.
  • Interventional study: A study where participants receive a planned intervention, such as a vaccine or medicine, so researchers can measure its effect.
  • Humoral immunity: Protection made by antibodies in the blood. Antibodies are proteins that help the body recognize and fight infection.
  • Serum sample: A blood sample used for laboratory testing. In this trial, serum was tested before and after vaccination.
  • Hemagglutination inhibition (HI): A laboratory test used to measure antibodies against influenza. It helps show whether the blood can block the virus from binding in the test.
  • Microneutralization test (NT): A lab test that checks whether antibodies can stop a virus from infecting cells.
  • Neutralization test: A test that measures whether antibodies can neutralize, or block, a virus.

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/