Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
660
Trial Sponsor
Clinical Trial Start Date
April 26, 2021
0Primary Completion Date
January 4, 2022
0Study Completion Date
January 4, 2022
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Biological0
Intervention Name
Placebo Tablet0
VXA-GI.1.NN0
Interventional Trial Phase
Phase 10
Participating Facility
Official Name
A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety and Immunogenicity of an Adenoviral-vector Based Oral Norovirus Vaccine Expressing GI.1 VP1 Administered Orally to Health Stable Older Adult Volunteers 55-80 Years of Age0
Last Updated
February 13, 2023
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Care Provider0
Participant0
Study summary
A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
