NCT01430689

Maternal Flu Vaccine Trial in Bamako, Mali

Prospective, Randomized, Controlled, Observer-Blind Trial to Measure the Efficacy, Safety and Immunogenicity of Trivalent Inactivated Influenza Vaccine and the Safety and Immunogenicity of Quadrivalent Meningococcal Polysaccharide Diphtheria Conjugate Vaccine in Pregnant Malian Women and Their Infants up to 6 Months of Age

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,193 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Influenza Vaccine Trivalent Types A and B	Pregnant Woman: Randomization to receive IM injection of Vaxigrip Influenza Vaccine once Household and Woman/Infant surveillance * Home visits weekly until the infant is born and reaches 6 months of age * If the woman, her infant or other household contact has signs and symptoms consistent with Influenza Like Illness (ILI)a nasal and oropharyngeal swab will be obtained
BIOLOGICAL	Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine	Pregnant Women - Randomized to receive IM injection of Menactra once Household and Woman/Infant surveillance * Home visits weekly until the infant is born and reaches 6 months of age * If the woman, her infant or other household contact has signs and symptoms consistent with Influenza Like Illness (ILI)a nasal and oropharyngeal swab will be obtained

Timeline

• Start date: 2011-09-12
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-09-08
• Last updated: 2019-09-26

Locations

1 site across 1 country: Mali