A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seaso… (NCT02918006) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
United States179 participantsStarted 2016-08-31
Plain-language summary
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion criteria
✓. Male or female volunteers aged 18 - 49 years, inclusive
✓. Able to give written informed consent
✓. Low pre-existing antibodies to the study vaccine
✓. In general good health (no clinically significant health concerns)
✓. Safety laboratory normal range or not clinically significant (NCS), with few exceptions
✓. Body mass index (BMI) between 17 and 35
✓. Comprehension of the study requirements with ability and willingness to complete all assessments and comply with scheduled visits and contacts
✓. Female participants must have a negative pregnancy test at screening
Exclusion criteria
✕. Receipt of any influenza vaccine within two years prior to study
✕. Use of any investigational vaccine/adjuvanted vaccine within 8 weeks of study
✕. Use of any investigational drug or device within 4 weeks of study
✕. Use of any licensed vaccine within 30 days of study
✕. Presence of significant uncontrolled medical or psychiatric illness within 3 months of study
What they're measuring
1
Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus
Timeframe: Clinical Illness and/or laboratory confirmed infection occurring following viral challenge at 3 months post vaccination