CPPROQVLP012_Phase 3_Plant derived Influenza Vaccine in Adults
Research type
Research Study
Full title
A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age.
IRAS ID
228111
Contact name
Essam Abdulhakim
Contact email
Sponsor organisation
Medicago R&D Inc.
Eudract number
2017-001239-38
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a randomised, observer-blind, placebo-controlled, multicentre, Phase 3 efficacy study for healthy adults 18 to 64 years of age. The influenza strain composition of the Quadrivalent VLP Influenza Vaccine will be based on the 2017-2018 recommended World Health Organisation (WHO) strains for vaccination.
The participant will participate in this study for approximately eight to ten months and it will involve a screening visit to assess their eligibility to participate, multiple phone calls and text messaging to monitor any symptoms of interest.
Approximately 10,000 participants at multiple sites in several countries. Participants will be randomised in 1:1 ratio to receive a single injection of the VLP vaccine at a dose of 30 micrograms (µg) (0.03 milligram [mg]) or a placebo. A placebo is a saline solution (water and salt) that does not contain the vaccine. Within the two treatment groups, participants will be stratified by site and two age groups (18 to 49 years of age and 50 to 64 years of age in a 1:1 ratio). Individuals will be randomly assigned to a treatment group by use of an interactive randomization system.
Seasonal influenza is a potentially serious infection associated with a wide range of clinical outcomes across the entire human lifespan. Despite continuing advances in understanding of the immune response to natural infection and immunization, the disease remains a major cause of morbidity and mortality worldwide. The main strategy for prevention and control of seasonal and pandemic influenza is still vaccination. The efficacy of vaccines are discouraging due to significant mismatch between vaccine and circulating strains. Medicago has developed a plant-derived Quadrivalent VLP Influenza Vaccine that could be protection against both matched and diverse influenza strains, particularly in the elderly who often derive significant benefit from vaccination despite little evidence of a humoural response.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0348
Date of REC Opinion
3 Oct 2017
REC opinion
Further Information Favourable Opinion