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NCT00142389 Clinical Trial

Mother's Gift Project

Pneumococcal Infections Clinical Trial

Official title:
Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00142389
Other study ID # 26748
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 1, 2005
Last updated June 21, 2011
Start date August 2004
Est. completion date December 2006

Study information
Verified date August 2005
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority Bangladesh: Directorate of Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 680
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• pneumococcal polysaccharide and protein conjugate vaccines

Locations
Country Name City State
Bangladesh ICDDRB Dhaka

Sponsors (6)
Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health 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

Country where clinical trial is conducted

Bangladesh, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
Primary local and systemic reactions within 2 weeks of vaccination
Secondary Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
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