Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

November 4, 2023

Primary Completion Date

March 25, 2024

Study Completion Date

July 31, 2025

Conditions
Influenza
Interventions
BIOLOGICAL

TetraFluvac TF vaccine

"The vaccine is a seasonal quadrivalent inactivated split virion influenza vaccine \[A/Sydney/5/2021(H1N1) pdm09-like virus and A/Darwin/9/2021 (H3N2)-like virus and B/Austria/1359417/2021 (B/Victoria Lineage)-like virus and B/Phuket/3073/2013 (B/Yamagata lineage)-like virus\] produced by The Government Pharmaceutical Organization (GPO), Thailand.~Each prefilled dose of TetraFluvac TF contains a total of 60 micrograms (μg) hemagglutinin (HA) per 0.5 ml dose (15 μg HA per strain per dose), to be administered by intramuscular (IM) injection."

BIOLOGICAL

Vaxigrip vaccine

"Vaxigrip vaccine is commercially available seasonal quadrivalent inactivated split virion influenza vaccine \[A/Sydney/5/2021(H1N1) pdm09-like strain and A/Darwin/9/2021 (H3N2)-like strain and B/Austria/1359417/2021-like strain and B/Phuket/3073/2013-like strain, manufactured by Sanofi Pasteur, Ltd. France.~Each prefilled dose of Vaxigrip vaccine contains a total of 60 micrograms (μg) hemagglutinin (HA) per 0.5 ml dose (15 μg HA per strain per dose), to be administered by intramuscular (IM) injection."

Trial Locations (1)

10400

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok

All Listed Sponsors
collaborator

The Government Pharmaceutical Organization

OTHER_GOV

lead

Mahidol University

OTHER

NCT05895955 - Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais | Biotech Hunter | Biotech Hunter