Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults
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|ClinicalTrials.gov Identifier: NCT03301051|
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Virus Diseases RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections||Biological: Quadrivalent VLP Vaccine Biological: Placebo||Phase 3|
This randomized, observer-blind, placebo-controlled multicenter, Phase 3 study will be conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine to be used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs for the 2017-2018 influenza virus strains.
Approximately 10,000 healthy male and female subjects aged 18 to 64 years will be randomized in a 1:1 ratio into one of two parallel treatment groups, such that approximately 5,000 subjects will receive the Quadrivalent VLP Influenza Vaccine at a dose of 30 μg/strain and approximately 5,000 subjects will receive the placebo. Within the two treatment groups, subjects will be stratified by site and two age groups (18-49 years of age and 50-64 years of age in a 1:1 ratio).
Subjects will participate in this study for approximately eight to ten months, during which a first visit will be scheduled on Day 0 for screening and vaccine administration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10137 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults 18-64 Years of Age|
|Actual Study Start Date :||August 31, 2017|
|Actual Primary Completion Date :||May 2, 2018|
|Actual Study Completion Date :||June 12, 2018|
Experimental: Quadrivalent VLP Vaccine
Single dose - 30 µg/strain of Quadrivalent VLP Vaccine
Biological: Quadrivalent VLP Vaccine
Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine
Other Name: 30 µg/strain of Quadrivalent VLP Vaccine
Placebo Comparator: Placebo
Single dose - Placebo
Single dose of a Placebo
- Time of occurence of protocol-defined respiratory illness due to laboratory-confirmed influenza caused by vaccine matched strains. [ Time Frame: 8 months ]
- Time of occurence of protocol-defined respiratory illness due to any laboratory-confirmed influenza strains. [ Time Frame: 8 months ]
- Number of subjects with solicited local and systemic reactions, unsolicited adverse events, serious adverse events and New Onset Chronic Diseases. [ Time Frame: 8 months ]
- Immunogenicity evaluated by the humoral immune response (HI, MN, and SRH assays) and the CMI response [ Time Frame: 21 days after injection ]• To assess, in a subset of 400 subjects, the immunogenicity of a single dose of Quadrivalent VLP Influenza Vaccine given at a dose of 30 μg/strain or placebo, as measured by hemagglutination inhibition (HI) assay, microneutralization (MN) assay, and single radial hemolysis (SRH) assay against homologous and heterologous (HI only) influenza strains.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301051
|Study Director:||Brian J Ward, MD||Medicago|