Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
80
Trial Sponsor
Clinical Trial Start Date
March 31, 2017
0Primary Completion Date
May 5, 2017
0Study Completion Date
April 3, 2018
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Other0
Intervention Type
Biological0
Intervention Name
VXA-A1.1 H1 Tablet Vaccine (small)0
VXA-A1.1 H1 Tablet Vaccine (large)0
Interventional Trial Phase
Phase 10
Official Name
A Phase 1, Open-Label, Randomized, 2×2 Crossover Study of Pharmacodynamics Comparing the Impact of Tablet Size and Fasting Status With an Oral Human Influenza A/California/04/2009 (H1N1) HA Adenoviral-Vector Based Vaccine and dsRNA Adjuvant0
Last Updated
May 30, 2018
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0
Study summary
This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasting versus fed status.
Timeline
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Further Resources
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