Maternal Flu Vaccine Trial in Bamako, Mali
Maternal Flu Vaccine Trial in Bamako, Mali
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 influenza infection, the "flu", affects pregnant women and their infants in Mali. The
 illness known as flu is caused by a germ (virus) that is passed easily among people. The flu
 causes symptoms such as fever, cough, sore throat, runny nose, and body aches. Certain groups
 of people, such as pregnant women and infants, are at risk for having severe disease when
 they get the flu. Vaccination against influenza is not routinely available to pregnant women
 in Mali although it is recommended.

 Women who wish to participate will have 5 visits to the clinic and weekly visits to the home
 to follow the health of the woman and her infant when it is born. The investigators will also
 ask permission to make weekly visits to all children under 5 years of age to follow their
 health as it relates to influenza infection.
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 up to 6 months of age. Women will be recruited in the 3rd trimester of
 pregnancy and vaccinated with either TIV or MCV. Safety assessments of the women will be
 completed 30 minutes and 1 week after vaccination, at delivery and 3 and 6 months after
 delivery. Safety assessments of the infants will be completed at birth and at 3 and 6 months
 of age. Immunogenicity assessments will include blood sampling of women immediately prior to
 vaccination, 4 weeks post-vaccination, at delivery and 3 and 6 months after delivery; infants
 will have cord blood collected at birth and peripheral blood collections at 3 and 6 months of
 age. Visits to ascertain the costs related to ILI and LCI will also be conducted. The
 majority of activities conducted in this trial are related to efficacy assessments which will
 continue until the newborn infant is 6 months of age. We will be conducting case detection
 for LCI via weekly household visits. In addition, hospital-based surveillance for
 meningococcal disease will be conducted to measure the efficacy of MCV.
Inclusion Criteria:

 1. Women in third trimester of pregnancy (≥ 28 weeks gestational age based upon last
 menstrual period, ultrasound or uterine height).

 2. Subject is able to understand and comply with planned study procedures.

 3. Subject has provided written informed consent prior to initiation of any study
 procedures.

 4. Subject intends to reside in the study area until her newborn infant is 6 months of
 age.

 Exclusion Criteria:

 1. Member of a household which already has a woman who is participating or has
 participated in this study

 2. History of severe reactions following previous immunization with influenza or
 meningococcal vaccines

 3. History of Guillain-Barré Syndrome

 4. Known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or
 any other components of Vaxigrip and Menactra

 5. 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

 6. Known active infection with human immunodeficiency virus (HIV), hepatitis B, or
 hepatitis C

 7. 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.

 8. 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)

 9. 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

 10. Woman who intends to travel out of the study area for the 40 days after delivery

 11. Receipt of immunoglobulins and/or any blood products within 30 days prior to the
 administration of study vaccines

 12. 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)

 13. 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