Pneumococcal Infections
Conditions
Keywords
gestational immunization,, infant antibody,, cord antibody
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.
Interventions
BIOLOGICALpneumococcal polysaccharide and protein conjugate vaccines
Sponsors
Thrasher Research Fund
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
Wyeth is now a wholly owned subsidiary of Pfizer
International Centre for Diarrhoeal Disease Research, Bangladesh
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age | — |
| local and systemic reactions within 2 weeks of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Level and duration of serum IgG antibody to pneumococcus up to 1 year of age. | — |
Countries
Bangladesh
Outcome results
None listed