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INFLUENZA A VIRUS SUBTYPE H1N1 HAEMAGGLUTININ, RECOMBINANT

Clinical trials are studying INFLUENZA A VIRUS SUBTYPE H1N1 HAEMAGGLUTININ, RECOMBINANT in influenza vaccine research. These studies look at immune response, safety, and how well different vaccine versions compare in adults, including older adults and people with stable health conditions.

Table of contents

Overview of the clinical trials

These studies investigate INFLUENZA A VIRUS SUBTYPE H1N1 HAEMAGGLUTININ, RECOMBINANT as part of influenza vaccine research in adults.[1][2] The main goals are to evaluate immune response, safety, and how different vaccine versions compare with each other.[1][2]

The trials are interventional studies, which means researchers give a study vaccine and then measure the results.[1][2] The condition being studied is influenza, human, and one trial also includes people with stable comorbidities that raise the risk of flu complications.[1][2][3]

Who participates in these studies

The Phase 2 studies include adults 18 years of age and older.[1][2] The Phase 3 study focuses on adults aged 50 years and older.[3]

One study includes healthy people and also people with stable medical conditions that increase the risk of complications from influenza infection.[3] In simple terms, this means the condition is present but not changing quickly.[3]

What the trials measure

The studies measure antibody titer, which is the amount of antibody found in the blood after vaccination.[1][2] They also measure the fold increase in antibody titer from Day 1 to Day 29, which shows how much the immune response grows after the study intervention.[1][2]

Another key outcome is seroconversion, meaning a clear rise in antibody response after vaccination.[1][2] The trials also measure seroprotection, which is a blood antibody level thought to give protection against influenza.[1][2]

Safety is measured by tracking solicited administration site or systemic events within 7 days, unsolicited adverse events within 28 days, serious adverse events within 6 months, adverse events of special interest within 6 months, medically attended adverse events within 6 months, and laboratory abnormalities at several time points.[1][2] These outcomes help show both short-term and longer-term safety after vaccination.[1][2]

Trial phases and study status

Two trials are in Phase 2, and one trial is in Phase 3.[1][2][3] Phase 2 studies usually look more closely at immune response and safety, while Phase 3 studies involve larger groups and help confirm the findings.[1][2][3]

The study with NCT07204964 is authorised, the study with 2025-522278-35-00 is completed, and the Celljuvant study 2023-503763-42-00 is also completed.[1][2][3] Enrollment ranges from 770 to 6300 participants across the trials.[1][2][3]

Details of the main trials

In the Phase 2 study 2025-522278-35-00, researchers assessed the immune response and safety of a vaccine against influenza in adults 18 years and older.[1] The study compared several vaccine products, including one that contains INFLUENZA A VIRUS SUBTYPE H1N1 HAEMAGGLUTININ, RECOMBINANT together with other influenza components.[1] The main immune readout was the antigen 1 antibody titer at Day 29.[1]

That same study also looked at fold increase in antibody titer, seroconversion, seroprotection, and multiple safety outcomes such as local and systemic reactions, adverse events, serious adverse events, and laboratory abnormalities.[1] This gives a broad picture of how the vaccine behaves after administration.[1]

In the authorised Phase 2 study NCT07204964, the same general goals were used: immune response and safety in adults 18 years and older.[2] The study again compared several influenza vaccine formulations, including one with INFLUENZA A VIRUS SUBTYPE H1N1 HAEMAGGLUTININ, RECOMBINANT, and measured the same main immune and safety endpoints at Day 29 and over follow-up periods.[2]

The Phase 3 Celljuvant study 2023-503763-42-00 focused on adults aged 50 years and older.[3] It first tested lot-to-lot consistency, which means whether three different production lots of the same vaccine gave similar immune responses.[3] Then it tested whether the vaccine was immunologically noninferior to two comparator vaccines, meaning it was not worse than them by a set scientific standard.[3]

In that Phase 3 study, the main immune measurements were Day 29 geometric mean titers and seroconversion rates for the four vaccine strains, using a hemagglutination inhibition assay with cell-derived target viruses.[3] This is a laboratory test used to measure the strength of the antibody response against influenza strains.[3]

Key patient terms

Interventional study means the research team gives a study treatment and then watches what happens.[1][2][3] Day 29 is a common follow-up point used to check the immune response after vaccination.[1][2][3]

Solicited events are side effects that the study specifically asks about after vaccination, while unsolicited adverse events are any other unwanted health problems reported during the study.[1][2] Serious adverse events are more severe problems that need special attention.[1][2]

Lot-to-lot consistency means checking whether different batches of the same vaccine perform in a similar way.[3] Noninferiority means the study vaccine is expected to work at least almost as well as a comparison vaccine, based on a pre-set rule.[3]

Trial ID Phase Condition studied Status Enrollment
2025-522278-35-00 Phase 2 Influenza, Human Completed 770
NCT07204964 Phase 2 Influenza, Human Authorised 960
2023-503763-42-00 Phase 3 Healthy individuals or individuals with stable comorbidities which increase their risk of complications from influenza infection Completed 6300

FAQ

  • What are the trials of INFLUENZA A VIRUS SUBTYPE H1N1 HAEMAGGLUTININ, RECOMBINANT trying to find out? They are mainly checking whether the vaccine helps the body build an immune response and whether it is safe. The studies also compare different vaccine lots and different vaccine types.
  • Who can take part in these studies? The trials include adults 18 years and older, and one large study focuses on adults aged 50 years and older. Some participants are healthy, while others have stable medical conditions that increase the risk of flu complications.
  • What phase are these clinical trials in? Two studies are in Phase 2, and one study is in Phase 3. Phase 2 and Phase 3 trials usually look at immune response, safety, and how well a vaccine works in larger groups.
  • What outcomes are being measured in the trials? The studies measure antibody levels, how much they rise after vaccination, seroconversion, and seroprotection. They also track local and general side effects, serious adverse events, and lab test changes.
  • What conditions are being studied? The main condition is influenza, human. One study also includes people with stable comorbidities, meaning other long-term health problems that are not changing quickly.

Sperimentazioni cliniche in corso su INFLUENZA A VIRUS SUBTYPE H1N1 HAEMAGGLUTININ, RECOMBINANT

  • Studio sulla risposta immunitaria e la sicurezza di un vaccino mRNA multivalente contro l’influenza stagionale in adulti di età pari o superiore a 18 anni

    Arruolamento concluso

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Belgio

  • Studio per valutare la risposta immunitaria e la sicurezza di un vaccino antinfluenzale stagionale a mRNA in adulti di età superiore ai 18 anni

    Arruolamento concluso

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Belgio

  • Studio sull’efficacia e sicurezza del vaccino aQIVc HD per l’influenza in adulti di 50 anni e oltre, confrontato con QIVr e aQIV.

    Arruolamento concluso

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Danimarca Estonia Germania

Glossario

  • Influenza: A flu infection caused by influenza viruses. The trials study vaccines meant to help prevent this disease.
  • Immune response: How the body reacts to a vaccine by making protection, such as antibodies.
  • Antibody: A protein made by the immune system that helps recognize and fight infection.
  • Antibody titer: A measure of how much antibody is in the blood.
  • Seroconversion: A change from having little or no measurable antibody to having a clear antibody response after vaccination.
  • Seroprotection: A blood antibody level considered high enough to give protection.
  • Reactogenicity: The short-term body reaction after a vaccine, such as pain at the injection site or other common symptoms.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the study treatment.
  • Serious adverse event: A severe medical problem that may need hospital care, cause lasting harm, or be life-threatening.
  • Comorbidity: Another health condition that a person has in addition to the main condition being studied.
  • Hemagglutination inhibition assay: A lab test used to measure antibodies against influenza strains.

Riferimenti

  1. https://clinicaltrials.gov/study/2025-522278-35-00
  2. https://studi-clinici.it/studio/studio-sulla-risposta-immunitaria-e-la-sicurezza-di-un-vaccino-mrna-multivalente-contro-linfluenza-stagionale-in-adulti-di-eta-pari-o-superiore-a-18-anni/
  3. https://clinicaltrials.gov/study/2023-503763-42-00