Oral Norovirus Vaccine Study on Healthy Subjects
common.study.values.description
“Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines”
VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for ~4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group ~4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
Biological - VXA-G1.1-NN
Monovalent GI.1 tableted vaccine
Biological - VXA-G2.4-NS
Monovalent GII.4 tableted vaccine
Biological - Placebo Tablets
Tablets matching in number and appearance to active vaccine doses
participant.views.study.view.additional
participant.views.study.view.scientific-title
A Ph 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 With Monovalent or Bivalent Dosing
common.study.values.clinical-trial-id
NCT03897309
participant.views.study.view.id
e5yEAe
