A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh

PHASE3CompletedINTERVENTIONAL
Enrollment

1,761

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Influenza
Interventions
BIOLOGICAL

SIIL Live Attenuated Influenza Vaccine

A single dose of SIIL Trivalent LAIV--2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010

BIOLOGICAL

Placebo

A single dose of inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.

Trial Locations (2)

Unknown

icddr, b Kamalapur, Dhaka

icddr,b Matlab, Matlab

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

collaborator

Centers for Disease Control and Prevention

FED

collaborator

Bill and Melinda Gates Foundation

OTHER

lead

PATH

OTHER

NCT01797029 - A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh | Biotech Hunter | Biotech Hunter