NCT03880474

Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults

A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults Aged 18 Years and Over

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,364 (actual)
• Sponsor: Barinthus Biotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults aged 18 years and over. To assess the effect of MVA-NP+M1 on the reduction of laboratory confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine (QIV) in adults

Detailed description

This is a Phase 2b, multicentre, randomised, single-blind study in up to 6000 adults to compare the efficacy, safety and immunogenicity of MVA-NP+M1 when given as an adjunct to a standard, licensed adult dose of QIV. The study will be conducted on an outpatient basis and will run over two consecutive influenza seasons. It is aimed to recruit 2200 participants in Season 1 and 2800-3800 participants in Season 2.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	MVA-NP+M1	Trial Vaccine
DRUG	Saline	Sodium Chloride Placebo

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-10-15
• Completion: 2020-01-21
• First posted: 2019-03-19
• Last updated: 2021-04-26
• Results posted: 2021-04-26

Locations

9 sites across 1 country: Australia