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.
Biological: pneumococcal polysaccharide and protein conjugate vaccines
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease|
- Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
- local and systemic reactions within 2 weeks of vaccination
- Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||December 2006|
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.
|Principal Investigator:||M C Steinhoff, MD||Johns Hopkins Bloomberg School of Public Health|