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Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults

NCT05975840 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2025-08-19

Study results available
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Summary

The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (\>=)18 years of age.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

FLU Q-PAN H5N8 375_B

Participants received 2 doses of 375\_B vaccine formulation by intramuscular injection in the non-dominant arm.

BIOLOGICAL

FLU Q-PAN H5N8 375_A

Participants received 2 doses of 375\_A vaccine formulation by intramuscular injection in the non-dominant arm.

BIOLOGICAL

FLU Q-PAN H5N8 750_B

Participants received 2 doses of 750\_B vaccine formulation by intramuscular injection in the non-dominant arm.

BIOLOGICAL

FLU Q-PAN H5N8 750_A

Participants received 2 doses of 750\_A vaccine formulation by intramuscular injection in the non-dominant arm.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2024-05-21
Completion
2024-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05975840 on ClinicalTrials.gov