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OpenTrials
Completed

NCT Number: NCT00142389

Mother's Gift Project

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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

ICDDRB

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pneumococcal polysaccharide and protein conjugate vaccines

Biological

Primary outcomes

  1. Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age

  2. local and systemic reactions within 2 weeks of vaccination

Secondary outcomes

  1. Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Thrasher Research Fund
  • United States Agency for International Development (USAID)
  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease

Important dates

Study start
2004
Study completion
2006
First posted
Sep 2, 2005
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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