Full name
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
NCT Number
NCT07121192
Geography
US
Locations
United States
Primary Endpoints
- Geometric Mean Titer (GMT) Ratio of Antigen 1 Titer at Day 29
- Geometric Mean Increase (GMI) of Antigen 1 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 Seroprotection Rate (SPR) at Day 1 and Day 29
- Number of Participants with Solicited Administration Site Adverse Events (Aes) from Day 1 to Day 7
- Number of Participants with Solicited Systemic Aes from Day 1 to Day 7
- Number of Participants with Unsolicited Aes from Day 1 to Day 28
- Number of Participants with Serious Adverse Events (SAEs) from Day 1 to Day 181 (study end)
- Number of Participants with Adverse Events of Special Interest (AESIs) from Day 1 to Day 181 (study end)
- Number of Participants with Medically Attended Adverse Events (MAAEs) from Day 1 to Day 181 (study end)
- Number of Participants with any Laboratory abnormalities from Day 1 to Day 29
Order
0
Disease
Version
Phase
2
Status
Recruiting