Status:
COMPLETED
Intramuscular CodaVax-H1N1 in Healthy Adults
Lead Sponsor:
Codagenix, Inc
Conditions:
Influenza, Human
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
This study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49 years. Participants wil...
Detailed Description
This study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49 years. Participants wil...
Eligibility Criteria
Inclusion
- Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2
- In good health with no history, or current evidence, of clinically significant medical conditions
- Negative SARS-CoV-2 test predose on Day 1
- For all women, negative pregnancy test
- Agreement to comply with conditions to prevent the spread of genetically modified organisms (GMOs)
Exclusion
- Pregnant or lactating women or women who plan to become pregnant through Day 29
- Inadequate venous access for repeated phlebotomy
- History of severe reaction to vaccination
- Receipt of any licenced or investigational influenza vaccine within 6 months before Day 1
- Receipt of any live vaccine within 30 days before Day 1
- Tattoo, skin reaction, or other condition at the injection site that would interfere with assessment of local reactogenicity
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05223179
Start Date
April 11 2022
End Date
February 9 2024
Last Update
September 19 2024
Active Locations (1)
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1
Lis Gilmour, Senior Project Manager
Morayfield, Queensland, Australia, QLD 4556