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mRNA Influenza Vaccines in Healthy Adults
NCT07431853Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2026
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Vaccines & Immunotherapeutics, mRNA Therapeutics
- Conditions
- influenza
01
Overview
Phase 2, randomised, double-blind trial of mRNA influenza vaccine in influenza (7 arms), sponsored by Pfizer. Primary endpoints: Percentage of participants reporting prespecified local reactions following vaccination at 7 days, Percentage of participants reporting prespecified systemic events following vaccination at 7 days and 3 more. Started Feb 2026; status: recruiting.
02
Design
7 arms- Study design
- RandomizedDouble-blind
Vaccine Candidate #1
mRNA influenza vaccine candidate #1 as a single intramuscular (IM) injection on Day 1.
Vaccine Candidate #2
mRNA influenza vaccine candidate #2 as a single IM injection on Day 1.
Vaccine Candidate #3
mRNA influenza vaccine candidate #3 as a single IM injection on Day 1.
Vaccine Candidate #4
mRNA influenza vaccine candidate #4 as a single IM injection on Day 1.
Vaccine Candidate #5
mRNA influenza vaccine candidate #5 as a single IM injection on Day 1.
Vaccine Candidate #6
mRNA influenza vaccine candidate #6 as a single IM injection on Day 1.
1 more in the full profile.
03
Who it enrols
Healthy adults 18 years and older, excluding those with recent (<= 5 months) influenza infection, influenza vaccination, or antiviral therapy for influenza.
04
Endpoints
Primary
Percentage of participants reporting prespecified local reactions following vaccination
Percentage of participants reporting prespecified systemic events following vaccination
Percentage of participants reporting adverse events
Percentage of participants reporting serious adverse events
Percentage of participants reporting newly diagnosed chronic medical conditions
Secondary
Geometric Mean Titer of Anti-Influenza Antibody Levels
Geometric Mean Fold Rise of Anti-Influenza Antibody Levels
Percentage of participants with satisfactory antibody response to the vaccine
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