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Trial intelligence / Profile preview
Recombinant TVLP Influenza Vaccine in Adults
NCT07291635Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Feb 2026
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- Aramis Biosciences
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- influenza
01
Overview
Phase 2, randomised, single-blind trial of recombinant TVLP influenza vaccine in influenza (7 arms), sponsored by Aramis Biosciences. Primary endpoints: Immediate Adverse Events at 30 minutes, Solicited local and systemic Adverse Events at 7 days and 4 more. Started Feb 2026; status: active, not recruiting.
02
Design
7 arms- Study design
- RandomizedSingle-blind
Group 1 (18-64): 15 μg
15 μg recombinant TVLP influenza vaccine
Group 2 (18-64): 30 μg
30 μg recombinant TVLP influenza vaccine
Group 3 (18-64): 60 μg
60 μg recombinant TVLP influenza vaccine
Group 4 (18-64): STD TIV
Standard dose commercial influenza vaccine
Group 5 (65+): 30 μg
30 μg recombinant TVLP influenza vaccine
Group 6 (65+): 60 μg
60 μg recombinant TVLP influenza vaccine
1 more in the full profile.
03
Who it enrols
Healthy adults 18 years and older with BMI <= 39 kg/m2, excluding those with significant medical illness, immunodeficiency, recent vaccinations, or history of Guillain-Barré Syndrome.
04
Endpoints
Primary
Immediate Adverse Events
Solicited local and systemic Adverse Events
Unsolicited Adverse Events
Urine, haematological and blood biochemistry values
Deaths, Serious Adverse Events, Adverse Events leading to withdrawal, Treatment-Emergent Adverse Events
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Competitive context
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