COVID-19 and flu
Conditions
Brief summary
A. Serum neutralizing antibody response (pseudotype, and whole virus neutralizing antibodies (VNAb)) to SARS-CoV-2 variants of concern (VOCs) at days 0, 10, and 28, B. Change in Geometric mean titres (GMT) of serum anti SARS-CoV-2 spike glycoprotein specific binding antibody – kinetics and magnitude at days 10, and 28, relative to those measured on Day 0, C. Longevity of humoral responses as measured by serum neutralizing antibody response (pseudotype, and whole VNAb) and binding antibody response to SARS-CoV-2 VOCs at day 90.
Detailed description
A. Characterization of cellular immunity (antigen specific cytotoxic T cells (CTL), T helper cells (Th) responses and T cell memory): ELISpot and/or intracellular cytokine staining (Flow cytometry) to SARS-CoV-2 at days 0 and 28, B. Longevity of cellular immune responses to SARS-CoV-2 as measured by cellular immunity assays (described under a) on day 90, Safety and reactogenicity A. The frequency and severity of solicited local (injection site) and systemic adverse events (AEs) reported within 7 days of vaccination, Safety and reactogenicity B. All unsolicited AEs reported within 28 days of vaccination;, Safety and reactogenicity C. All serious adverse events (SAEs) reported from day 0 until day 90 or end of trial.
Interventions
DRUGSaline injection as placebo comparator
DRUGdose 0
DRUG5 ml
DRUGNaCl 0
DRUG9%
DRUGSingle-shot
DRUGIntramuscular injection
DRUGInfluvac sub-unit Tetra
DRUGsuspension for injection in pre-filled syringe (influenza vaccine
DRUGsurface antigen
DRUGinactivated)
DRUGComirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
DRUGFluad Tetra
DRUGinactivated
DRUGadjuvanted)
Sponsors
Cr2o B.V.
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. Serum neutralizing antibody response (pseudotype, and whole virus neutralizing antibodies (VNAb)) to SARS-CoV-2 variants of concern (VOCs) at days 0, 10, and 28, B. Change in Geometric mean titres (GMT) of serum anti SARS-CoV-2 spike glycoprotein specific binding antibody – kinetics and magnitude at days 10, and 28, relative to those measured on Day 0, C. Longevity of humoral responses as measured by serum neutralizing antibody response (pseudotype, and whole VNAb) and binding antibody response to SARS-CoV-2 VOCs at day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| A. Characterization of cellular immunity (antigen specific cytotoxic T cells (CTL), T helper cells (Th) responses and T cell memory): ELISpot and/or intracellular cytokine staining (Flow cytometry) to SARS-CoV-2 at days 0 and 28, B. Longevity of cellular immune responses to SARS-CoV-2 as measured by cellular immunity assays (described under a) on day 90, Safety and reactogenicity A. The frequency and severity of solicited local (injection site) and systemic adverse events (AEs) reported within 7 days of vaccination, Safety and reactogenicity B. All unsolicited AEs reported within 28 days of vaccination;, Safety and reactogenicity C. All serious adverse events (SAEs) reported from day 0 until day 90 or end of trial. | — |
Countries
Belgium, Netherlands
Outcome results
None listed