Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP)
- Disease/Condition
- H7N9 Influenza
- Drug/Device/Intervention
- Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection
- Study type
- Interventional
- Intervention type
- biological
- Primary sponsor
- Vaxxas Pty Ltd
- Location
- Morayfield,Sippy Downs,South Brisbane,East Melbourne, Australia
- Phase
- Phase 1
- Start date
- Jul 05, 2024
- End date
- May 01, 2026
- Enrollment
- 258 participants
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.
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06417853
- Type
- Non-Device Trial
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.