Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

889

Participants

Timeline

Start Date

March 20, 2017

Primary Completion Date

October 5, 2017

Study Completion Date

October 5, 2017

Conditions
Influenza, Human
Interventions
BIOLOGICAL

IVACFLU-S

"IVACFLU-S is seasonal inactivated, split virion, trivalent influenza vaccine (A/H3N2, A/H1N1, and B), produced in GCP facility by IVAC uses embryonated chicken eggs. This vaccine is purified by sucrose gradient ultracentrifugation (Alfa Wassermann, West Caldwell, NJ), and inactivated with formaldehyde. Each 0.5 mL dose of vaccine contains~* NYMC X-179A (A/California/7/2009) (H1N1) - 15μg hemagglutinin (HA)~* NYMC X-263B (A/HongKong/4801/2014) (H3N2) - 15μg HA~* NYMC BX-35 (B/Brisbane/60/2008) (B) - 15μg HA"

OTHER

Placebo

Phosphate buffered saline with pH 7.2; 0.5 ml/per dose

Trial Locations (1)

Unknown

Pasteur Institute, Ho Chi Minh City, Ho Chi Minh City

All Listed Sponsors
collaborator

Pasteur Institute, Ho Chi Minh City

OTHER_GOV

collaborator

PATH

OTHER

collaborator

Quintiles, Inc.

INDUSTRY

collaborator

World Health Organization

OTHER

lead

Institute of Vaccines and Medical Biologicals, Vietnam

INDUSTRY

NCT03095599 - Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3 | Biotech Hunter | Biotech Hunter