Mother's Gift Project
Phase 1
Completed
- Conditions
- Pneumococcal Infections
- Registration Number
- NCT00142389
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 680
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age local and systemic reactions within 2 weeks of vaccination
- Secondary Outcome Measures
Name Time Method Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
Trial Locations
- Locations (1)
ICDDRB
🇧🇩Dhaka, Bangladesh