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WILD-TYPE A INFLUENZA VIRUS A/BELGIUM/4217/2015 (H3N2)

Clinical trials are studying WILD-TYPE A INFLUENZA VIRUS A/BELGIUM/4217/2015 (H3N2) in healthy adults as part of an influenza research study. The trial looks at whether the study treatment can reduce flu illness and checks safety, tolerability, and side effects.

Table of contents

Trial overview

The clinical trial listed for WILD-TYPE A INFLUENZA VIRUS A/BELGIUM/4217/2015 (H3N2) was titled “A phase 2a study of CR9114 in healthy adult participants.”[1] It studied influenza virus in the setting of a controlled research trial and was marked as completed.[1]

This was an interventional study, which means people received a study treatment or a placebo so researchers could compare results.[1] The trial enrolled 140 participants.[1]

Who participated

The study was done in healthy adult participants.[1] This means the trial was not in people who already had the illness as a long-term condition, but in adults chosen so researchers could study the effect of the research treatment in a controlled way.

The intervention list included CR9114, a CR9114 placebo nasal solution, and WILD-TYPE A INFLUENZA VIRUS A/BELGIUM/4217/2015 (H3N2) given by intranasal use, which means through the nose.[1]

Study design and phase

This was a Phase 2 trial.[1] Phase 2 studies are used to look for early signs that a treatment may help and to keep checking safety in a larger group than very early trials.

The study summary said the main aims were to determine the effect of CR9114 on reducing the incidence of MMID and to determine its safety and tolerability.[1] MMID means mild to moderate influenza disease.

What was measured

The main outcome was the incidence of MMIDa, measured by the InFLUenza Patient Reported Outcome (FLU-PRO) Plus© questionnaire.[1] This questionnaire uses patient-reported symptoms, meaning the participants report how they feel and what symptoms they have.

The study also measured the frequency and severity of treatment-emergent adverse events and serious adverse events.[1] Treatment-emergent adverse events are health problems that start after treatment begins, while serious adverse events are major medical problems that need special attention.

The intervention dose for WILD-TYPE A INFLUENZA VIRUS A/BELGIUM/4217/2015 (H3N2) was listed as 1000000 TCID50/dose by intranasal use.[1] TCID50 is a lab measure used to describe the amount of virus that can infect cells.

Study goals

The trial was designed to see whether the study treatment could reduce the chance of mild to moderate influenza disease.[1] It also aimed to learn how safe the treatment was and how well participants could tolerate it.[1]

Because the study was completed, the available record shows that the trial has finished collecting its planned data.[1]

Key patient terms

  • Placebo: an inactive nasal solution used for comparison in a trial.
  • Tolerability: how well a person can handle a study treatment without too many problems.
  • Adverse event: any unwanted health problem that happens during a study.
  • Serious adverse event: a severe health problem that may need urgent medical care.
  • Patient-reported outcome: information about symptoms that comes directly from the participant.
  • Intranasal: given through the nose.
Trial ID Phase Condition studied Status Enrollment
2023-505020-57-00 Phase 2 Influenza virus Completed 140

FAQ

  • What is being studied in these trials? The trial includes WILD-TYPE A INFLUENZA VIRUS A/BELGIUM/4217/2015 (H3N2) as part of an influenza challenge study. Researchers are looking at whether the study treatment can lower the chance of getting influenza illness.
  • Who can take part in the study? The trial is in healthy adult participants. That means people without the illness being studied are enrolled so researchers can measure how the study treatment works in a controlled setting.
  • What phase is this trial? This is a Phase 2 study. Phase 2 trials usually look at early signs of benefit and continue to check safety in a larger group than first-in-human studies.
  • What outcomes are being measured? The main outcomes are the incidence of MMIDa, measured with the FLU-PRO Plus questionnaire, and the frequency and severity of treatment-emergent adverse events and serious adverse events. MMIDa means mild to moderate influenza disease.
  • Is this trial only about safety? No. The trial is also designed to see if the treatment can reduce the incidence of influenza illness. Safety and tolerability are also important parts of the study.

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

  • Study on the Effectiveness and Safety of CR9114 for Preventing Influenza in Healthy Adults

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Influenza virus: The virus that causes flu. In this trial, the virus is used in a research setting to study influenza illness.
  • Healthy adult participants: Adults who do not have the illness being studied and who take part in research to help test how a study treatment works.
  • Phase 2: A mid-stage clinical trial that looks for early signs that a treatment may work and keeps checking safety.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare results.
  • Intranasal use: Given through the nose.
  • TCID50: A lab measure used to describe the amount of virus that can infect cells. It helps define the dose used in the study.
  • MMIDa: Mild to moderate influenza disease, a study outcome used to track how often flu illness happens.
  • FLU-PRO Plus: A patient-reported questionnaire used to record flu symptoms and how bad they are.
  • Treatment-emergent adverse events: New health problems or side effects that start after treatment begins.
  • Serious adverse events: Serious medical problems during a study, such as events that need urgent care or cause major harm.
  • Tolerability: How well people can handle a treatment without too many side effects or problems.

References

  1. https://clinicaltrials.gov/study/2023-505020-57-00