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Maternal Flu Vaccine Trial in Bamako, Mali

NCT01430689 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4193

Last updated 2019-09-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Milagritos D Tapia, MD · University of Maryland, College Park

  • Myron M Levine, MD, DTPH · University of Maryland, College Park

  • Samba O Sow, MD · Centre pour le Developpement des Vaccins - Mali

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-12
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Mali

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01430689 on ClinicalTrials.gov