NCT06417853

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

Phase I Clinical Study to Evaluate the Safety and Tolerability of a Monovalent Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) in Healthy Adults Aged 18 to 50 Years
Vaxxas Pty Ltd·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
H7N9 Influenza
Drug/Device/Intervention
Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Vaxxas Pty Ltd
Location
Morayfield,Sippy Downs,South Brisbane,East Melbourne, Australia
Timeline & enrollment
Phase
Phase 1
Start date
Jul 05, 2024
End date
May 01, 2026
Enrollment
258 participants
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
Influenza, virus not identifiedHaemophilus influenzae infection, unspecified siteHaemophilus influenzae [H. influenzae] as the cause of diseases classified to other chaptersInfluenza with other manifestations, virus not identifiedInfluenza due to identified seasonal influenza virus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06417853
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06417853 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vaxxas Pty Ltd and is currently Not yet recruiting. The study focuses on H7N9 Influenza. Target enrollment is 258 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.