Mother's Gift Project

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00142389
First received: September 1, 2005
Last updated: June 21, 2011
Last verified: August 2005

September 1, 2005
June 21, 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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
 
Completed
680
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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT00142389
26748
Not Provided
Not Provided
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