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ClinicalTrials.gov Identifier: NCT00142389
Recruitment Status :
First Posted : September 2, 2005
Last Update Posted : June 23, 2011
Johns Hopkins Bloomberg School of Public Health
Thrasher Research Fund
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
Wyeth is now a wholly owned subsidiary of Pfizer
International Centre for Diarrhoeal Disease Research, Bangladesh
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 these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.
Condition or disease
Biological: pneumococcal polysaccharide and protein conjugate vaccines
Phase 1Phase 2
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.
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Ages Eligible for Study:
18 Years to 40 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.