Clinical Trial: Mother's Gift Project
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
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.
Detailed Summary: 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.
Sponsor: Johns Hopkins Bloomberg School of Public Health
Current Primary Outcome:
- Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
- local and systemic reactions within 2 weeks of vaccination
Original Primary Outcome: Same as current
Current Secondary Outcome: Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
Original Secondary Outcome: Same as current
Information By: Johns Hopkins Bloomberg School of Public Health
Dates:
Date Received: September 1, 2005
Date Started: August 2004
Date Completion: December 2006
Last Updated: June 21, 2011
Last Verified: August 2005
