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INFLUENZA A VIRUS A/BELGIUM/4217/2015 (H3N2)

Clinical trials investigating “INFLUENZA A VIRUS A/BELGIUM/4217/2015 (H3N2)” are studying how this influenza virus is used in research settings. The trial data focus on safety, tolerability, body levels over time, and effects on viral measures in healthy adults, including people exposed to influenza H3N2.

Table of contents

Trial overview

The clinical trial data describe one interventional study, which means researchers gave a study treatment and then measured what happened.[1] The study looked at EV25 given through the nose, and it also included a setting where participants were exposed to INFLUENZA A VIRUS A/BELGIUM/4217/2015 (H3N2).[1]

The study was completed and enrolled 122 people.[1] It was designed to learn about safety, tolerability, and the amount of EV25 in the body over time.[1]

Who participated

The study included healthy adult people.[1] Part I studied healthy participants taking a single nasal dose, and Part II studied healthy participants exposed to influenza H3N2.[1]

This means the trial was not focused on people with severe illness or long-term disease, but on healthy volunteers in an early research setting.[1]

What was studied

The study tested EV25 given by the intranasal route, which means through the nose.[1] Researchers compared EV25 with a placebo nasal spray in the influenza-exposed part of the trial.[1]

A placebo is a look-alike treatment that does not contain the active study drug, and it helps researchers compare results fairly.[1] The study also included wild-type A Influenza Virus A/Belgium/4217/2015 (H3N2), which is the natural virus form used in the research setting.[1]

Main endpoints

The primary safety measures in Part I were adverse events, laboratory safety assessments, 12-lead ECG findings, vital signs, physical examination findings, and intranasal administration site examination findings.[1] These measures help researchers see whether the study treatment caused any safety concerns.[1]

The study also aimed to measure the PK profile, which shows how much EV25 is in the body over time after a single dose.[1] In Part II, researchers looked at the effect of single doses of EV25 on viral AUC compared with placebo in healthy participants who had positive predose values.[1]

Viral AUC means the total amount of virus measured over time, so it gives a summary of how the virus changed during the study.[1]

Trial phase and status

The trial was in Phase 1/2, an early stage that usually starts with safety and then begins to explore effects in the body.[1] The study status was completed.[1]

The trial was single-dose, meaning participants received one dose during the study.[1] The brief summary shows that researchers separated the work into two parts: one for healthy participants and one for healthy participants exposed to influenza H3N2.[1]

Patient-friendly terms

  • Healthy participants: people without the illness being studied, used to help researchers understand safety and early effects.[1]
  • Vital signs: basic body checks like pulse and blood pressure.[1]
  • Physical examination: a doctor’s body check to look for health problems.[1]
  • Intranasal administration: treatment given through the nose.[1]
  • Laboratory safety assessments: lab tests used to watch for problems in the body.[1]
  • ECG: a heart test that records electrical signals from the heart.[1]
Trial IDPhaseCondition studiedStatusEnrollment
2024-514832-26-00Phase 1/2Virus InfluenzaCompleted122

FAQ

  • What is being studied in trials of INFLUENZA A VIRUS A/BELGIUM/4217/2015 (H3N2)? The trials study safety, tolerability, and how the body handles EV25 when it is given through the nose. They also look at how EV25 affects viral measures in healthy people exposed to influenza H3N2.
  • Who can take part in these trials? The trial data describe healthy adult people. Some parts of the study include healthy participants without influenza exposure, while other parts include healthy participants exposed to influenza H3N2.
  • What phase is the trial? The study is in Phase 1/2. This means it is an early-stage trial that looks at safety first and also begins to study effects in the body.
  • What conditions are being studied? The listed condition is Virus Influenza. The study also includes healthy participants exposed to influenza H3N2 to see how the trial treatment behaves in that setting.
  • What results are the researchers measuring? They measure side effects, lab tests, ECG findings, vital signs, physical exam findings, and nasal exam findings. They also measure the amount of EV25 in the body over time and viral AUC, which means the total viral amount over time.

Ongoing Clinical Trials on INFLUENZA A VIRUS A/BELGIUM/4217/2015 (H3N2)

  • Study on the Safety and Effects of Intranasal EV25 in Healthy Adults with and without Influenza Virus Exposure

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Adverse events (AEs): Any unwanted medical problems that happen during a study, whether or not they are caused by the study treatment.
  • AUC: Area under the curve. In this study, it means the total amount of virus measured over time.
  • ECG: Electrocardiogram. A test that records the heart's electrical activity.
  • Enrollment: The number of people planned or included in a study.
  • Interventional study: A study where researchers give a treatment or intervention to see what happens.
  • Intranasal: Given through the nose.
  • Laboratory safety assessments: Blood or other lab tests used to check for possible safety problems.
  • Phase 1/2: An early study phase that checks safety and starts to look at effects in the body.
  • PK profile: Pharmacokinetic profile. This shows how much of a study drug is in the body over time.
  • Tolerability: How well people can handle a treatment without too many side effects or problems.
  • Vital signs: Basic body measures such as blood pressure, pulse, temperature, and breathing rate.
  • Wild-type virus: The natural form of a virus, not a changed or modified version.

References