A Phase 1/2, randomized, dose-finding/dose-confirmation study to evaluate the reactogenicity, safety and immunogenicity of mRNA-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults

Conditions

Healthy volunteers (prevention of influenza infection)

Brief summary

Percentage of participants reporting each solicited administration site event (From Day 1 to Day 7), Percentage of participants reporting each solicited systemic event (From Day 1 to Day 7), Percentage of participants reporting unsolicited adverse events (AEs) (From Day 1 to Day 28), Percentage of participants reporting serious adverse events (SAEs) (From Day 1 to Day 183), Percentage of participants reporting adverse events of special interest (AESIs) (From Day 1 to Day 183), Percentage of participants reporting medically attended events (MAEs) (From Day 1 to Day 183), Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry (Phase 1 only), Geometric mean titer (GMT) of antigen 1 antibody titer (Day 29), Geometric mean increase (GMI) of antigen 1 antibody titer (From Day 1 to Day 29), Percentage of participants with antigen 1 seroconversion rate (SCR) (From Day 1 to Day 29), Percentage of participants with antigen 1 titer >= cut off value (Day 1 and Day 29), GMT of antigen 2 antibody titer (Day 29), GMI of antigen 2 antibody titer (From Day 1 to Day 29), Percentage of participants with antigen 2 SCR (From day 1 to Day 29)

Detailed description

GMT of antigen 1 antibody titer (Day 92 and Day 183), GMI of antigen 1 antibody titer (From Day 1 to Day 92), GMI of antigen 1 antibody titer (From Day 1 to Day 183), Percentage of participants with antigen 1 titer >= cut off value (Day 183), GMT of antigen 2 antibody titer (Day 92 and Day 183), GMI of antigen 2 antibody titer (From Day 1 to Day 92), GMI of antigen 2 antibody titer (From Day 1 to Day 183)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGAlpharix-Tetra

DRUGsuspensie voor injectie in een voorgevulde spuit Griepvaccin (gefragmenteerd

DRUGgeïnactiveerd virion)

DRUGsuspension injectable en seringue préremplie Vaccin antigrippal (virion fragmenté

DRUGinactivé)

DRUGEFLUELDA

DRUGsuspensie voor injectie in een voorgevulde spuit Quadrivalent griepvaccin (gesplitst virion

DRUGgeïnactiveerd)

DRUG60 microgram HA/stam

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants reporting each solicited administration site event (From Day 1 to Day 7), Percentage of participants reporting each solicited systemic event (From Day 1 to Day 7), Percentage of participants reporting unsolicited adverse events (AEs) (From Day 1 to Day 28), Percentage of participants reporting serious adverse events (SAEs) (From Day 1 to Day 183), Percentage of participants reporting adverse events of special interest (AESIs) (From Day 1 to Day 183), Percentage of participants reporting medically attended events (MAEs) (From Day 1 to Day 183), Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry (Phase 1 only), Geometric mean titer (GMT) of antigen 1 antibody titer (Day 29), Geometric mean increase (GMI) of antigen 1 antibody titer (From Day 1 to Day 29), Perc	—

Measure

Time frame

Percentage of participants reporting each solicited administration site event (From Day 1 to Day 7), Percentage of participants reporting each solicited systemic event (From Day 1 to Day 7), Percentage of participants reporting unsolicited adverse events (AEs) (From Day 1 to Day 28), Percentage of participants reporting serious adverse events (SAEs) (From Day 1 to Day 183), Percentage of participants reporting adverse events of special interest (AESIs) (From Day 1 to Day 183), Percentage of participants reporting medically attended events (MAEs) (From Day 1 to Day 183), Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry (Phase 1 only), Geometric mean titer (GMT) of antigen 1 antibody titer (Day 29), Geometric mean increase (GMI) of antigen 1 antibody titer (From Day 1 to Day 29), Perc

—

Secondary

Measure	Time frame
GMT of antigen 1 antibody titer (Day 92 and Day 183), GMI of antigen 1 antibody titer (From Day 1 to Day 92), GMI of antigen 1 antibody titer (From Day 1 to Day 183), Percentage of participants with antigen 1 titer >= cut off value (Day 183), GMT of antigen 2 antibody titer (Day 92 and Day 183), GMI of antigen 2 antibody titer (From Day 1 to Day 92), GMI of antigen 2 antibody titer (From Day 1 to Day 183)	—