In short
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.
Key points
- Clinical trials involving WILD-TYPE A INFLUENZA VIRUS A/BELGIUM/4217/2015 (H3N2) are studying influenza in healthy adult participants. The main trial is a Phase 2 interventional study with 140 people enrolled. It looks at whether the study treatment can reduce mild to moderate influenza disease and also checks safety and tolerability. The main measurements include flu symptoms reported by participants and the number and severity of treatment-emergent and serious adverse events. The trial status is completed.
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.” It studied influenza virus in the setting of a controlled research trial and was marked as completed.
This was an interventional study, which means people received a study treatment or a placebo so researchers could compare results. The trial enrolled 140 participants.
Who participated
The study was done in healthy adult participants. 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.
Study design and phase
This was a Phase 2 trial. 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. 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. 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. 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. 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. It also aimed to learn how safe the treatment was and how well participants could tolerate it.
Because the study was completed, the available record shows that the trial has finished collecting its planned data.
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.