Universal Influenza A Vaccine in Healthy Adults
NCT05155319 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2025-01-20
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
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
-
Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
NCT01560793 ·Status: COMPLETED ·Phase: PHASE1
-
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
NCT00545701 ·Status: COMPLETED ·Phase: PHASE2
-
Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above
NCT05829356 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
NCT06382311 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults
NCT06125691 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza
NCT05227001 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
NCT00562484 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers
NCT02385123 ·Status: TERMINATED ·Phase: PHASE4
-
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
NCT00125944 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects
NCT00630331 ·Status: COMPLETED ·Phase: PHASE3
-
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1
NCT01594320 ·Status: COMPLETED ·Phase: PHASE1
-
Pandemic Influenza Plasmid DNA Vaccines (Needle)
NCT00709800 ·Status: COMPLETED ·Phase: PHASE1
-
Inactivated Influenza A/H5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses
NCT00417560 ·Status: WITHDRAWN ·Phase: NA
-
Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals
NCT03816878 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Reactogenicity and Immunogenicity of an H5N1 VLP
NCT00519389 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity of Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
NCT01045564 ·Status: WITHDRAWN ·Phase: PHASE2
-
A/H5N1 Dose Ranging Study With Adjuvant Patch
NCT00532792 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability and Immunogenicity of a Universal Influenza A Vaccine
NCT01265914 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
NCT06602531 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Immune Response to a Live H7N9 Influenza Virus Vaccine Followed by an Inactivated H7N9 Influenza Virus Vaccine, Given at Varying Intervals
NCT02151344 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults
NCT02335164 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
NCT00973349 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Phase 1b Influenza Vaccine Study in Healthy Subjects
NCT01181336 ·Status: COMPLETED ·Phase: PHASE1
-
Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu
NCT03789539 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
NCT00953524 ·Status: COMPLETED ·Phase: PHASE2