Status:
COMPLETED
Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP
Lead Sponsor:
Vaxess Technologies
Collaborating Sponsors:
ICON plc
Q2 Solutions
Conditions:
Influenza
Eligibility:
All Genders
18-39 years
Phase:
PHASE1
Brief Summary
A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenz...
Eligibility Criteria
Inclusion
- Male or female aged 18 - 39 years inclusive
- Provide written informed consent to participate
- Healthy participants without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- o As determined by medical history, physical exam, laboratory screening
- Body Mass Index 18-35 kg/m2, inclusive, at screening
Exclusion
- Any medical condition that in the judgement of the investigator would make subject participation in the study unsafe.
- Having cancer or received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
- Impaired immune responsiveness (of any cause), including diabetes mellitus.
- Receipt or plan to receive a non-study vaccine within 30 days prior to vaccination or 60 days after vaccination.
- Receipt of any influenza vaccine in previous 24 months and/or planned receipt of influenza vaccine for the duration of the study.
- Diagnosed influenza infection in the previous 24 months prior to screening.
- Diagnosed COVID infection via medical personnel or at home test within the past 60 days prior to screening
- Allergy to influenza vaccine or components, or history of severe local or systemic reaction to any vaccination.
- History of anaphylactic type reaction to injected vaccines
- History of or current allergy to latex
- History of Guillain-Barré Syndrome.
- Positive test result for hepatitis B surface antigen (HBsAg,), hepatitis C virus antibody (HBcAb), or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
- History of chronic obstructive pulmonary disease or history of other lung disease.
- History of severe allergic reactions to eggs.
Key Trial Info
Start Date :
July 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06125717
Start Date
July 2 2022
End Date
March 13 2023
Last Update
November 9 2023
Active Locations (3)
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1
Centricity Research Toronto
Toronto, Ontario, Canada, M9W 4L6
2
Centricity Research Mirabel
Mirabel, Quebec, Canada, J7J 2K8
3
Centricity Research Pointe-Claire
Pointe-Claire, Quebec, Canada, H9R 4S3