NCT02669121

Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults

Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Healthy Adults Aged 18 - 49 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4,748 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV strains.

Detailed description

The vaccine being tested in this study is called NoV GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide. The norovirus vaccine is being tested to prevent AGE due to genotype-specific (GI.1 and GII.4) norovirus strains in healthy participants recruited from a US military training installation. This study will look at the illness rate of AGE occurring \> 7 days after dosing due to genotype-specific (GI.1 or GII.4) NoV strains represented in the vaccine. The study will enroll between 2800 and 8700 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Norovirus GI.1/GII.4 Bivalent VLP Vaccine * Placebo (dummy inactive solution) - this is a liquid that looks similar to the study drug but has no active ingredient All participants will receive one dose of study medication on Day 1 administered via intramuscular injection. This multi-center trial will be conducted in the United States at select military locations. The overall time to participate in this study is up to 45 days for participants in the navy 53 days for participants in the Air Force, and 72 days for participants in the marines. Participants will make multiple visits to the clinic, including a final visit on the last day of study participation (Day 45, 53 or 72) for a follow-up assessment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	NoV Placebo-matching Saline	NoV placebo-matching saline (0.9% sodium chloride).
BIOLOGICAL	NoV GI.1/GII.4 Bivalent VLP Vaccine	NoV bivalent VLP vaccine, adjuvanted with 500 µg aluminum as Al(OH)3.

Timeline

• Start date: 2016-06-14
• Primary completion: 2018-06-16
• Completion: 2018-06-16
• First posted: 2016-01-29
• Last updated: 2021-06-10
• Results posted: 2021-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study