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Mother's Gift Project

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ClinicalTrials.gov Identifier: NCT00142389
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 23, 2011
Information provided by:

September 1, 2005
September 2, 2005
June 23, 2011
August 2004
Not Provided
  • Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
  • local and systemic reactions within 2 weeks of vaccination
Same as current
Complete list of historical versions of study NCT00142389 on ClinicalTrials.gov Archive Site
Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
Same as current
Not Provided
Not Provided
Mother's Gift Project
Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
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.
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.
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Pneumococcal Infections
Biological: pneumococcal polysaccharide and protein conjugate vaccines
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2006
Not Provided

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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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
Principal Investigator: M C Steinhoff, MD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP