A randomized first-in-human, Phase 1, single-center, observer-blind, active-controlled 3-arm study to evaluate the safety, tolerability, and immunogenicity of one single administration of TETRALITE, a novel adjuvanted influenza vaccine, in healthy participants aged 18 to 50 years
Phase 1
- Conditions
- InfluenzaMedDRA version: 20.0Level: PTClassification code: 10022000Term: Influenza Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2022-500681-98-00
- Lead Sponsor
- itevax B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method