NCT02475278

Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Norovirus
• Healthy Participants

Interventions

Type	Name	Description
BIOLOGICAL	NoV GI.1/GII.4 Bivalent VLP Vaccine	Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide for IM injection

Timeline

• Start date: 2015-02-26
• Primary completion: 2015-04-07
• Completion: 2015-09-09
• First posted: 2015-06-18
• Last updated: 2018-02-22
• Results posted: 2016-10-28

Locations

1 site across 1 country: United States