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Mother's Gift Project

NCT00142389 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2011-06-23

No results posted yet for this study

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.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

pneumococcal polysaccharide and protein conjugate vaccines

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • M C Steinhoff, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-08-31
Completion
2006-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00142389 on ClinicalTrials.gov