Universal Influenza A Vaccine in Healthy Adults

NCT05155319 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-01-20

No results posted yet for this study

Summary

The goal of this Phase 1, single- center, randomized, double blind, placebo-controlled dose-escalation study is to evaluate the safety, tolerability and immunogenicity of UFluA vaccine candidate at two dose levels and two schedules in healthy adult (18-45-year-old, inclusive) male and non-pregnant female subjects.

Conditions

  • Human Influenza

Interventions

BIOLOGICAL

UFluA 20 µg each antigen/dose

Low dose

BIOLOGICAL

UFluA 60 µg each antigen/dose

High Dose

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • James McCarthy, MD · Emergent BioSolutions

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-10-10
Completion
2023-10-10

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05155319 on ClinicalTrials.gov