We did this prospective, active-controlled, observer-blind, randomised phase 4 trial at six referral centres and community health centres in Bamako, Mali. In the year before starting the trial, influenza activity occurred from September to April, with peaks in October and February.
Third-trimester pregnant women (≥28 weeks' gestation based on last menstrual period, ultrasound, or uterine height) presenting to participating health centres for prenatal care were eligible for inclusion. Participants had to be able to understand and comply with planned study procedures, provide written informed consent before initiation of any study procedures, and intend to reside in the study area until their newborn infants were 6 months old. Participants could not be members of a household that already had a woman who was participating or had participated in this study. Other exclusion criteria were a history of severe reactions following previous immunisation with influenza or meningococcal vaccines; Guillain–Barré syndrome; known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or any other components of trivalent inactivated influenza vaccine (Vaxigrip) and quadrivalent meningococcal conjugate vaccine (Menactra); known chronic medical disorder that, in the judgment of the investigator, could compromise assessment of the study vaccine or put the participant at risk; known active infection with HIV, hepatitis B virus, or hepatitis C virus; complications with the ongoing pregnancy, including preterm labour (with cervical change), placental abruption, premature rupture of membranes, known major congenital anomaly, or pre-eclampsia; acute illness or an oral temperature greater than or equal to 37·8°C within 72 h of vaccination (resulted 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) before vaccination in this study; receipt of immunoglobulins or any blood products within 30 days before administration of study vaccines; chronic administration of immunosuppressants or other immune-modifying drugs within 90 days before administration of study vaccines; or any disorder that, in the opinion of the investigator, might compromise the wellbeing of the participant or compliance with study procedures, or interfere with the assessment of study vaccines. We additionally excluded women who intended to travel out of the study area in the 40 days after delivery. Enrolment continued until the requisite number of laboratory-confirmed influenza cases was detected in infants born to vaccinated women.
Approval for the research was obtained from the University of Maryland, Baltimore Institutional Review Board; the ethics committee of the Faculté de Médecine, Pharmacie et Odonto-Stomatologie of Mali; and the Ministry of Health of Mali. Community sensitisation was achieved through community leaders, health centre representatives and community members who attended community-wide meetings. All participants provided informed consent. If the participant was illiterate, consent was obtained in the presence of a literate witness after listening to the audiotaped version of the consent form in Bambara, the local language.
Third-trimester pregnant women (≥28 weeks' gestation based on last menstrual period, ultrasound, or uterine height) presenting to participating health centres for prenatal care were eligible for inclusion. Participants had to be able to understand and comply with planned study procedures, provide written informed consent before initiation of any study procedures, and intend to reside in the study area until their newborn infants were 6 months old. Participants could not be members of a household that already had a woman who was participating or had participated in this study. Other exclusion criteria were a history of severe reactions following previous immunisation with influenza or meningococcal vaccines; Guillain–Barré syndrome; known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or any other components of trivalent inactivated influenza vaccine (Vaxigrip) and quadrivalent meningococcal conjugate vaccine (Menactra); known chronic medical disorder that, in the judgment of the investigator, could compromise assessment of the study vaccine or put the participant at risk; known active infection with HIV, hepatitis B virus, or hepatitis C virus; complications with the ongoing pregnancy, including preterm labour (with cervical change), placental abruption, premature rupture of membranes, known major congenital anomaly, or pre-eclampsia; acute illness or an oral temperature greater than or equal to 37·8°C within 72 h of vaccination (resulted 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) before vaccination in this study; receipt of immunoglobulins or any blood products within 30 days before administration of study vaccines; chronic administration of immunosuppressants or other immune-modifying drugs within 90 days before administration of study vaccines; or any disorder that, in the opinion of the investigator, might compromise the wellbeing of the participant or compliance with study procedures, or interfere with the assessment of study vaccines. We additionally excluded women who intended to travel out of the study area in the 40 days after delivery. Enrolment continued until the requisite number of laboratory-confirmed influenza cases was detected in infants born to vaccinated women.
Approval for the research was obtained from the University of Maryland, Baltimore Institutional Review Board; the ethics committee of the Faculté de Médecine, Pharmacie et Odonto-Stomatologie of Mali; and the Ministry of Health of Mali. Community sensitisation was achieved through community leaders, health centre representatives and community members who attended community-wide meetings. All participants provided informed consent. If the participant was illiterate, consent was obtained in the presence of a literate witness after listening to the audiotaped version of the consent form in Bambara, the local language.
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