Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) - Trial NCT06417853

Timeline & Enrollment

Primary Outcome

Incidence, severity and duration of solicited systemic adverse reactions including fever, headache, malaise, myalgia, arthralgia, fatigue, sweating and shivering from Day 1 through Day 8 (Dose 1) and Day 22 through Day 29 (Dose 2);,Incidence, severity and duration of local adverse reactions including erythema, swelling, induration, ecchymosis, and vaccination site pain from Day 1 through Day 8 (Dose 1) and Day 22 through Day 29 (Dose 2);,Incidence and severity of unsolicited (spontaneously reported) treatment-emergent adverse events (TEAEs) from Day 1 through Day 78;,Incidence and severity of SAEs, MAAEs and PIMMCs from Day 1 through Day 387;,Incidence and severity of Application Site Reactogenicity Adverse Events with onset after Day 78 from Day 79 through Day 387;,Number of Participants with Clinically Significant Changes in Laboratory Tests from Day 1 to Day 387;,Number of Participants with Clinically Significant Changes in Physical Examination from Day 1 to Day 387,Number of Participants with Clinically Significant Changes in Vital Signs from Day 1 through Day 387;,Local skin response, assessed by photo imaging and standardised scoring, measured at 10 minutes and 1 hour following application on Day 1 and Day 22, and at Days 4, 8, 29, and 78;,Concomitant medication usage.

Summary

Study SP-1219-007 is a multi-centre, randomised, study designed to access the safety and
 tolerability of two doses of monovalent Influenza A (H7N9) vaccine delivered intradermally by
 a microarray patch delivery system in healthy adults aged 18 to 50 years.

ICD-10 Classifications