NCT01527825View on ClinicalTrials.gov

Immunogenicity and Safety of Different Dosing Schedules of Trivalent Influenza Vaccine in HIV-infected Pregnant Women

PHASE3CompletedINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Influenza
Interventions
BIOLOGICAL

Trivalent influenza vaccine (seasonal)

"Single 0.5ml dose of Southern hemisphere 2012 TIV, formulation containing:~* An A/California/7/2009 (H1N1)pdm-like virus~* An A/Perth/16/2009 (H3N2)-like virus\*~* A B/Brisbane/60/2008-like virus \* A/Wisconsin/15/2009 and A/Victoria/210/2009 are A/Perth/16/2009-like viruses for use in the 2012 Southern Hemisphere winter. This vaccine is the same as the vaccine used for the 2011 Southern hemisphere influenza season."

BIOLOGICAL

Normal saline

0.5ml normal saline will be used as 'placebo' vaccine to maintain blinding

Trial Locations (1)

2013

Respiratory and Meningeal Pathogens research unit, Soweto, Johannesburg

All Listed Sponsors
lead

University of Witwatersrand, South Africa

OTHER

NCT01527825 - Immunogenicity and Safety of Different Dosing Schedules of Trivalent Influenza Vaccine in HIV-infected Pregnant Women | Biotech Hunter | Biotech Hunter