NCT06842173 - Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults | Biotech Hunter

Enrollment

700

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

July 31, 2026

Conditions

Avian Influenza A Virus

Interventions

BIOLOGICAL

Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg

Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg + IB160 adjuvant (0.5mL total)

BIOLOGICAL

Monovalent influenza vaccine type A (H5N8) 15 mcg

Monovalent influenza vaccine type A (H5N8) 15 mcg + IB160 adjuvant (0.5mL total)

OTHER

Placebo

Phosphate buffered saline (PBS) (0.5 mL/dose).

Trial Locations (5)

30750-140

NOT_YET_RECRUITING

Centro de Terapias Avançadas E Inovadoras - Ct Terapias/Ufmg, Belo Horizonte

52011-040

RECRUITING

Plátano Centro de Pesquisa Clínica LTDA, Recife

15090-000

NOT_YET_RECRUITING

Fundação Faculdade Regional de Medicina de São Jose do Rio Preto - (Centro integrado de Pesquisa CIP), São José do Rio Preto

Unknown

NOT_YET_RECRUITING

Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preta da Universidade de São Paulo - (Centro de Pesquisa Clínica - S), Serrana

05403-010

NOT_YET_RECRUITING

Centro de Pesquisas Clínicas do Hospital das Clínicas da FMUSP, São Paulo