Healthy Participants Clinical Trial
Official title:
Phase II, Single Arm, Open Label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine.
The vaccine being tested in this study is called Norovirus GI.1/GII.4 bivalent Virus-Like
Particle Vaccine (NoV Vaccine). The purpose of this study is to collect serum samples to
evaluate serologic assays and to establish proficiency panels for serologic assays used for
assessment of post vaccination immune response after intramuscular (IM) vaccination with the
NoV vaccine. The validation and proficiency testing of the immunogenicity assays is required
to support the NoV Vaccine development program. This study also looked at side effects in
people who were administered a single dose of the NoV vaccine.
The study enrolled 50 patients. All participants received one dose of the NoV vaccine via
intramuscular injection.
Participants were asked to record any symptoms that may be related to the vaccine or the
injection site in a diary card for 7 days after receiving the vaccination.
This single-centre trial was conducted in the United States. The overall time to participate
in this study was 183 days. Participants made 4 visits to the clinic, and were contacted by
telephone 183 days after last dose of study drug for a follow-up assessment.
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