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HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS

Clinical trials investigating HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS study how well it works and how safe it is in selected groups of participants. The trial data provided here focus on study design, target populations, phases, and outcome measures. In the source data, the main trial is about meningococcal and related vaccines, not this rotavirus strain.

Table of contents

Overview of the available trial data

The provided source data contain one interventional study with the identifier NCT05082285, but it is not a rotavirus trial and does not study HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS directly.[1] Instead, it evaluates meningococcal and related vaccine responses, including safety and immune outcomes.[1]

The study is listed as completed and includes 703 participants.[1] Because only this trial is provided, the article focuses on the clinical research features that are actually reported in the source data.[1]

Study design and phase

This was a Phase 1 study, which is usually an early stage of research that looks first at safety and the body’s immune response.[1] The study type was interventional, meaning participants received study vaccines and then outcomes were measured over time.[1]

The brief summary says the researchers wanted to evaluate the safety and reactogenicity of two formulations of MenABCWY-2nd Gen vaccine, the MenABCWY-1st Gen vaccine, the MenB vaccine, and the MenACWY-TT vaccine.[1] It also aimed to assess immune response against serogroup B indicator strains and against serogroups A, C, W, and Y.[1]

Participants and target population

The trial enrolled 703 participants, but the provided data do not give more detail about age, sex, or other entry rules.[1] So, the exact target population cannot be described beyond the information shown in the source record.[1]

The condition listed for the study is Infections, Meningococcal, which means the research is linked to protection against meningococcal disease.[1] No participant-level details are given in the source material about who was excluded or included.[1]

Main outcomes measured

The primary outcomes focus on safety and immune response.[1] Safety outcomes include the number and percentage of participants with solicited administration site and systemic events during the 7 days after each vaccination, as well as unsolicited adverse events during the 30 days after each vaccination.[1]

The study also tracks medically attended adverse events, serious adverse events, adverse events leading to withdrawal, and adverse events of special interest throughout the study.[1] These terms mean the researchers are watching for both common short-term reactions and more important health problems that may happen later.[1]

For immune response, the study measures human serum bactericidal assay titres, also called hSBA titres, and hSBA geometric mean titres (GMTs) for serogroups A, C, W, Y, and B indicator strains.[1] It also measures hSBA geometric mean ratios at day 331 compared with the time before the third vaccination.[1]

Trial details in the source data

The trial title is MENACWY=MEN7B-003, and its status is Completed.[1] The interventions include several vaccines given by injection or oral use, including Nimenrix, Prevenar 13, Rotarix, Infanrix hexa, and Bexsero.[1]

Rotarix is described in the source as a rotavirus vaccine, live, given by oral use.[1] However, the trial itself is not presented as a study of HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS, and the source data do not state that exact substance name.[1]

The study compares immune responses to different vaccine formulations against meningococcal serogroups and related indicator strains.[1] This makes the available trial information useful for understanding vaccine research design, even though it does not directly match the requested substance name.[1]

What these results mean for patients

For patients, the most important point is that this source record describes a vaccine study that checks how safe the vaccines are and how strong the immune response is.[1] The study uses blood tests and side-effect tracking to see whether the vaccines produce the expected protection and whether they are tolerated well.[1]

Because the dataset provided here includes only one completed Phase 1 study, it does not allow a full review of clinical trials specifically for HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS.[1] The article therefore stays close to the trial facts that are actually reported and does not add information that is not in the source.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05082285 Phase 1 Infections, Meningococcal Completed 703

FAQ

  • What are clinical trials investigating HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS trying to find out? They are designed to check safety, immune response, and how the vaccine performs in the study population. The provided trial data mainly describe vaccine research with measured side effects and antibody responses.
  • Who can take part in these trials? The source data do not list detailed eligibility criteria. In general, the study includes selected participants who meet the trial rules set by the researchers.
  • What phase are the trials in? The trial data provided here include a Phase 1 study. Phase 1 usually means an early study that looks first at safety and immune response.
  • What conditions are being studied? The provided trial is listed under meningococcal infections. It also measures responses to several vaccine groups, including serogroups A, C, W, Y, and B.
  • What outcomes are measured in the trial? The study measures side effects after vaccination and immune response tests such as human serum bactericidal assay, also called hSBA. It looks at both short-term and longer-term results during the study.

Sperimentazioni cliniche in corso su HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS

  • Studio sui vaccini combinati contro il meningococco di gruppo ABCWY per neonati sani

    Arruolamento concluso

    1 1 1
    Farmaci in studio:
    Germania Polonia Spagna

Glossario

  • Clinical trial: A planned research study in people that checks whether a vaccine or treatment is safe and works as expected.
  • Phase 1: An early trial phase that mainly studies safety and the body’s first immune response.
  • Interventional study: A study in which researchers give a vaccine or treatment and then measure the results.
  • Enrollment: The number of participants who are included in the study.
  • Safety: How well a vaccine is tolerated and whether unwanted effects are seen.
  • Reactogenicity: The short-term reactions after vaccination, such as local or general symptoms that are tracked after each dose.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the vaccine.
  • Serious adverse event: An adverse event that is severe, for example one that is life-threatening or needs hospital care.
  • Medically attended adverse event: A health problem that leads to medical care, such as a clinic visit or treatment.
  • Human serum bactericidal assay (hSBA): A lab test used to measure how well antibodies in the blood can help kill bacteria.
  • Geometric mean titre (GMT): An average level of antibodies measured in the blood, often used in vaccine studies.
  • Serogroup: A subgroup of a germ, defined by its surface features. In this study, serogroups A, C, W, Y, and B are measured.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sulla-sicurezza-e-risposta-immunitaria-del-vaccino-menabcwy-per-la-meningite-nei-neonati-sani/