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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
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.
Details
| Lead sponsor | University of Maryland, Baltimore |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 4193 |
| Start date | 2011-09-12 |
| Completion | 2014-01 |
Conditions
- Influenza
Interventions
- Inactivated Influenza Vaccine Trivalent Types A and B
- Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine
Primary outcomes
- Number of infants with influenza whose mothers received vaccine at any time during the 3rd trimester — 2 years
To compare the incidence of laboratory-confirmed influenza (LCI) among infants up to 6 months of age born to mothers immunized with trivalent influenza vaccine (TIV) during the 3rd trimester of pregnancy versus infants born to mothers who received meningococcal conjugate vaccine (MCV) during the 3rd trimester of pregnancy (intention-to-treat (ITT) comparison)
Countries
Mali