Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

December 31, 2012

Conditions
Influenza
Interventions
BIOLOGICAL

IVACFLU

IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.

OTHER

Placebo

Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.

Trial Locations (1)

Unknown

Ben Luc Health Center, Bến Lức

All Listed Sponsors
collaborator

Institute of Vaccines and Medical Biologicals, Vietnam

INDUSTRY

collaborator

Pasteur Institute, Ho Chi Minh City

OTHER_GOV

lead

PATH

OTHER

NCT01507779 - Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine | Biotech Hunter | Biotech Hunter