Full name
A Phase 1/2, Randomized, Dose-finding/Doseconfirmation Study to Evaluate the Reactogenicity, Safety and Immunogenicity of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults
NCT Number
NCT05823974
Geography
US
Non-US
Locations
Belgium, Canada, South Africa, United States
Primary Endpoints
- 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
- Percetage of partcipants 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. From Day 1 (pre-dose) to Day 8 (post-dose) and/or Day 29 (post-dose)
- Geometric mean titer (GMT) of antigen 1 antibody titer. At 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. At Day 1 and Day 29
- GMT of antigen 2 antibody titer. At 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
External Link
https://clinicaltrials.gov/study/NCT05823974
Order
1
Disease
Version
Phase
1/2