Status:
COMPLETED
Mother's Gift Project
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Thrasher Research Fund
Bill and Melinda Gates Foundation
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of ...
Detailed Description
This is a randomized vaccine evaluation in 4 groups of mothers and their infants, to assess the effect of maternal immunization on the infants' response to pneumococcal vaccine.
Eligibility Criteria
Inclusion
- Mothers from 18 to 14 years of age in the third trimester of pregnancy,
- with normal medical and obstetric history,
- who plan to deliver their infant in Dhaka city and remain there for 12m
Exclusion
- Maternal history of systemic disease,
- Maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies.
- Maternal hypersensitivity to any vaccination, or
- Maternal receipt of pneumococcal vaccine in the last 3 years.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT00142389
Start Date
August 1 2004
End Date
December 1 2006
Last Update
June 23 2011
Active Locations (1)
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1
ICDDRB
Dhaka, Bangladesh