Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP (NCT06125717) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP
Canada45 participantsStarted 2022-07-02
Plain-language 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 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age
Who can participate
Age range18 Years – 39 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 reacti…
What they're measuring
1
To determine the safety of VX-103 delivered as a single MIMIX MAP immunization