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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
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

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 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 Intervention/treatment Phase
Pneumococcal Infections Biological: pneumococcal polysaccharide and protein conjugate vaccines Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
Study Start Date : August 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
  2. local and systemic reactions within 2 weeks of vaccination

Secondary Outcome Measures :
  1. Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142389


Locations
Bangladesh
ICDDRB
Dhaka, Bangladesh
Sponsors and Collaborators
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
Investigators
Principal Investigator: M C Steinhoff, MD Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00142389     History of Changes
Other Study ID Numbers: 26748
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: August 2005

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
gestational immunization,
infant antibody,
cord antibody

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs