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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

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

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

Estimated Enrollment: 680
Study Start Date: August 2004
Estimated Study Completion Date: December 2006
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00142389     History of Changes
Other Study ID Numbers: 26748
Study First Received: September 1, 2005
Last Updated: June 21, 2011
Health Authority: Bangladesh: Directorate of Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014