NCT05975840

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

A Phase I/II Observer-blind, Randomized, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System (Referred to as Q-Pan H5N8), Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-08-03
• Primary completion: 2024-05-21
• Completion: 2024-09-19
• First posted: 2023-08-04
• Last updated: 2025-08-19
• Results posted: 2025-02-20

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study