A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers (NCT04372719) | Clinical Trial Compass
CompletedPhase 1
A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers
36 participantsStarted 2016-11-02
Plain-language summary
This is a non-controlled, open-label, single-centre, dose-escalation study to determine the safety, infectivity and immunology of the potential novel influenza virus H3N2 challenge strain. The term 'challenge agent' used in this protocol refers to the Influenza virus H3N2 A/Belgium/4217/2015. The study utilises an adaptive study design and consists of 2 parts.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, between 18 and 55 years old (extremes included) at screening.
. In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening.
. Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by a MNT titre of ≤ 20 at screening.
. Negative urine test for selected drugs of abuse at screening and upon check-in at the clinical site.
. Negative alcohol breath test
. Female subjects should fulfil one of the following criteria:
. At least 1 year post-menopausal (amenorrhea \>12 months and/or follicle-stimulating hormone (FSH) \> 30 mIU/mL) prior to screening;
. Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
Exclusion criteria
. Subjects who have received any vaccination within the last 3 months prior to screening or influenza vaccine within the last 12 months prior to screening or who anticipate receiving this during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
safety profile
Timeframe: through study completion, an average of 3 months
2
Efficacy: Infectivity
Timeframe: through study completion, an average of 3 months
3
Efficacy: observed attack rate
Timeframe: through study completion, an average of 3 months
Trial details
NCT IDNCT04372719
SponsorSGS Life Sciences, a division of SGS Belgium NV
. Subjects with a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 6 months prior to screening.
. Subjects with a positive result for adventitious agent screening (qualitative PCR testing) for any respiratory virus or bacteria on Day -2.
. Haematology and chemistry parameters, pulse rate and/or blood pressure, and ECG outside the reference range for the population studied and considered as clinical significant by the Investigator.