A Phase 2a randomized, observer-blind, study to evaluate the immunogenicity and safety of mRNA-based multivalent seasonal influenza vaccine candidates in adults 18 years of age and older.

Conditions

Influenza, Human

Brief summary

Primary end points 1 • Antigen 1 antibody titer at Day 29, • Fold increase in antigen 1 antibody titer from Day 1 to Day 29, • Antigen 1 antibody seroconversion from Day 1 to Day 29, • Antigen 1 antibody seroprotection at Day 1 and Day 29, Primary end points 2 • Occurrence of solicited administration site or systemic events with onset within 7 days of study intervention, • Occurrence of unsolicited AEs within 28 days of study intervention, • Occurrence of SAEs within 6 months of study intervention, • Occurrence of AESIs within 6 months of study intervention, • Occurrence of MAAEs within 6 months of study intervention, • Occurrence of any laboratory abnormalities pre-dose (Day 1), post-Dose (Day 3, Day 8, Day 29)

Detailed description

Secondary end points 1 - • Antigen 2 antibody titer at Day 29, • Fold increase in antigen 2 antibody titer from Day 1 to Day 29, • Antigen 2 antibody seroconversion from Day 1 to Day 29

Related papers

No related papers found yet.

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

Interventions

DRUGAlpharix suspensie voor injectie in een voorgevulde spuit Trivalent griepvaccin (gefragmenteerd virion

DRUGgeïnactiveerd)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary end points 1 • Antigen 1 antibody titer at Day 29, • Fold increase in antigen 1 antibody titer from Day 1 to Day 29, • Antigen 1 antibody seroconversion from Day 1 to Day 29, • Antigen 1 antibody seroprotection at Day 1 and Day 29, Primary end points 2 • Occurrence of solicited administration site or systemic events with onset within 7 days of study intervention, • Occurrence of unsolicited AEs within 28 days of study intervention, • Occurrence of SAEs within 6 months of study intervention, • Occurrence of AESIs within 6 months of study intervention, • Occurrence of MAAEs within 6 months of study intervention, • Occurrence of any laboratory abnormalities pre-dose (Day 1), post-Dose (Day 3, Day 8, Day 29)	—

Measure

Time frame

Primary end points 1 • Antigen 1 antibody titer at Day 29, • Fold increase in antigen 1 antibody titer from Day 1 to Day 29, • Antigen 1 antibody seroconversion from Day 1 to Day 29, • Antigen 1 antibody seroprotection at Day 1 and Day 29, Primary end points 2 • Occurrence of solicited administration site or systemic events with onset within 7 days of study intervention, • Occurrence of unsolicited AEs within 28 days of study intervention, • Occurrence of SAEs within 6 months of study intervention, • Occurrence of AESIs within 6 months of study intervention, • Occurrence of MAAEs within 6 months of study intervention, • Occurrence of any laboratory abnormalities pre-dose (Day 1), post-Dose (Day 3, Day 8, Day 29)

—

Secondary

Measure	Time frame
Secondary end points 1 - • Antigen 2 antibody titer at Day 29, • Fold increase in antigen 2 antibody titer from Day 1 to Day 29, • Antigen 2 antibody seroconversion from Day 1 to Day 29	—

Countries

Belgium

Outcome results

None listed