Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Nonpregnant HIV Uninfected Women

PHASE4CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

April 30, 2014

Conditions
Influenza
Interventions
BIOLOGICAL

Trivalent Influenza Vaccine

"The formulation based on the WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:~* an A/California/7/2009 (H1N1)pdm09-like virus;~* an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus.~The vaccine to be used in the study in 2013 is Vaxigrip (Sanofi Pasteur), or other equivalent licensed vaccine should the latter not be available, which will be procured commercially in pre-filled syringes. Using aseptic technique, participants will be injected with 0.5 mL of TIV from pre-filled syringe."

Trial Locations (1)

2055

Nrf/Dst Vpd Rmpru, Soweto

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

University of Witwatersrand, South Africa

OTHER

NCT01816464 - Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Nonpregnant HIV Uninfected Women | Biotech Hunter | Biotech Hunter