Status:
COMPLETED
A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers
Lead Sponsor:
SGS Life Sciences, a division of SGS Belgium NV
Conditions:
Influenza, Human
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 'c...
Detailed Description
In Part 1, the primary objective is to determine the viral challenge strain dose that has an acceptable safety profile and an observed attack rate of \>60% (i.e., at least 8 out of 12 subjects should ...
Eligibility Criteria
Inclusion
- 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);
- Will use contraceptives as outlined in inclusion criterion 8 from screening to discharge.
- Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge.
- 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.
- 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.
- Has an acute or chronic medical condition
Exclusion
Key Trial Info
Start Date :
November 2 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04372719
Start Date
November 2 2016
End Date
December 28 2016
Last Update
May 4 2020
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