Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01430689
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2011-09-06
Brief Title:
Maternal Flu Vaccine Trial in Bamako Mali
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
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
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None