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

NCT06417853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • H7N9 Influenza

Interventions

BIOLOGICAL

Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection

7.5 mcg Influenza A (H7N9) Injection

COMBINATION_PRODUCT

Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA)

12 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)

COMBINATION_PRODUCT

Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA)

25 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)

BIOLOGICAL

Adjuvanted Influenza A (H7N9) Monovalent Vaccine Injection

7.5 mcg Influenza A (H7N9) with MF59® Injection

COMBINATION_PRODUCT

Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, low dose adjuvant)

12 mcg Influenza A (H7N9) with 4 mcg QS21 Microarray Patch Delivery System (VXS-1219A)

COMBINATION_PRODUCT

Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, high dose adjuvant)

12 mcg Influenza A (H7N9) with 8 mcg QS21 Microarray Patch Delivery System (VXS-1219A)

COMBINATION_PRODUCT

Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, low dose adjuvant)

20 mcg Influenza A (H7N9) with 3.3 mcg QS21 Microarray Patch Delivery System (VXS-1219A)

COMBINATION_PRODUCT

Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, high dose adjuvant)

20 mcg Influenza A (H7N9) with 6.7 mcg QS21 Microarray Patch Delivery System (VXS-1219A)

DEVICE

Microarray Patch Delivery System

Vaccine free Microarray Patch Delivery System (VXS-1219U)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-01-30
Completion
2026-01-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06417853 on ClinicalTrials.gov