Status:
COMPLETED
Maternal Flu Vaccine Trial in Bamako, Mali
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Influenza
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The Center for Vaccine Development - Mali is interested in learning if vaccinating a pregnant woman against influenza will protect her infant against this disease. The investigators know that influenz...
Detailed Description
This is a prospective, randomized, controlled observer-blind trial measuring the efficacy, safety and immunogenicity of TIV and the safety and immunogenicity of MCV in pregnant women and their infants...
Eligibility Criteria
Inclusion
- Women in third trimester of pregnancy (≥ 28 weeks gestational age based upon last menstrual period, ultrasound or uterine height).
- Subject is able to understand and comply with planned study procedures.
- Subject has provided written informed consent prior to initiation of any study procedures.
- Subject intends to reside in the study area until her newborn infant is 6 months of age.
Exclusion
- Member of a household which already has a woman who is participating or has participated in this study
- History of severe reactions following previous immunization with influenza or meningococcal vaccines
- History of Guillain-Barré Syndrome
- Known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or any other components of Vaxigrip and Menactra
- Known chronic medical condition that in the judgment of the investigator could compromise the evaluation of the study vaccine or puts the subject at risk
- Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Any of the following complications with the ongoing pregnancy: preterm labor (with cervical change), placental abruption, premature rupture of membranes, known major congenital anomaly, or preeclampsia.
- Acute illness and/or an oral temperature greater than or equal to 37.8 degrees C, within 72 hours of vaccination (This may result in a temporary delay of vaccination)
- Receipt of any other vaccine, excluding tetanus toxoid, within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines and meningococcal A conjugate vaccine (MenAfriVac)) prior to vaccination in this study
- Woman who intends to travel out of the study area for the 40 days after delivery
- Receipt of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to administration of study vaccines (including systemic corticosteroids, e.g. prednisone or equivalent \> 0.5 mg/kg/day; topical and inhaled steroids are allowed)
- Any condition which in the opinion of the investigator might compromise the well-being of the participant or compliance with study procedures or interfere with the evaluation of the study vaccines
Key Trial Info
Start Date :
September 12 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
4193 Patients enrolled
Trial Details
Trial ID
NCT01430689
Start Date
September 12 2011
End Date
January 1 2014
Last Update
September 26 2019
Active Locations (1)
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1
Centre pour le Developpement des Vaccins - Mali
Bamako, Mali