Status:
COMPLETED
Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Nonpregnant HIV Uninfected Women
Lead Sponsor:
University of Witwatersrand, South Africa
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Influenza
Eligibility:
FEMALE
18-39 years
Phase:
PHASE4
Brief Summary
The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in HIV-uninfected pregnant women compared with HIV-uninfected non-pregnant women in 2013. Safety data will also be ...
Eligibility Criteria
Inclusion
- All women
- (i) Documented to be HIV-1 uninfected on one assay used in the Prevention of Mother to Child Transmission (PMTCT)/ other program undertaken within 12 weeks of study enrolment.
- (ii) Able to understand and comply with planned study procedures. (iii) Provides written informed consent prior to initiation of study. (iv) Women age ≥ 18 years to \< 39 years.
- pregnant women
- (i) Gestational age ≥20 weeks to \<36 weeks documented by the approximate date of the last menstrual period and corroborated by physical exam and sonar report if available.
Exclusion
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01816464
Start Date
September 1 2013
End Date
April 1 2014
Last Update
January 12 2015
Active Locations (1)
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1
Nrf/Dst Vpd Rmpru
Soweto, GP, South Africa, 2055