Back to resultsMother's Gift Project
Primary Purpose
Pneumococcal Infections
Status
Completed
Phase
Phase 1
Locations
Bangladesh
Study Type
Interventional
Intervention
pneumococcal polysaccharide and protein conjugate vaccines
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections focused on measuring gestational immunization,, infant antibody,, cord antibody
Eligibility Criteria
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.
Sites / Locations
- ICDDRB
Outcomes
Primary Outcome Measures
Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
local and systemic reactions within 2 weeks of vaccination
Secondary Outcome Measures
Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
Full Information
NCT ID
NCT00142389
First Posted
September 1, 2005
Last Updated
June 21, 2011
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT00142389
Brief Title
Mother's Gift Project
Official Title
Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
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
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
gestational immunization,, infant antibody,, cord antibody
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
680 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
pneumococcal polysaccharide and protein conjugate vaccines
Primary Outcome Measure Information:
Title
Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
Title
local and systemic reactions within 2 weeks of vaccination
Secondary Outcome Measure Information:
Title
Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M C Steinhoff, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDDRB
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
Citations:
PubMed Identifier
23967126
Citation
Schlaudecker EP, Steinhoff MC, Omer SB, McNeal MM, Roy E, Arifeen SE, Dodd CN, Raqib R, Breiman RF, Zaman K. IgA and neutralizing antibodies to influenza a virus in human milk: a randomized trial of antenatal influenza immunization. PLoS One. 2013 Aug 14;8(8):e70867. doi: 10.1371/journal.pone.0070867. eCollection 2013.
Results Reference
derived
PubMed Identifier
23300160
Citation
Omer SB, Zaman K, Roy E, Arifeen SE, Raqib R, Noory L, Seib K, Breiman RF, Steinhoff MC. Combined effects of antenatal receipt of influenza vaccine by mothers and pneumococcal conjugate vaccine receipt by infants: results from a randomized, blinded, controlled trial. J Infect Dis. 2013 Apr;207(7):1144-7. doi: 10.1093/infdis/jit003. Epub 2013 Jan 8.
Results Reference
derived
PubMed Identifier
22353593
Citation
Steinhoff MC, Omer SB, Roy E, El Arifeen S, Raqib R, Dodd C, Breiman RF, Zaman K. Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial. CMAJ. 2012 Apr 3;184(6):645-53. doi: 10.1503/cmaj.110754. Epub 2012 Feb 21.
Results Reference
derived
PubMed Identifier
18799552
Citation
Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E, Omer SB, Shahid NS, Breiman RF, Steinhoff MC. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008 Oct 9;359(15):1555-64. doi: 10.1056/NEJMoa0708630. Epub 2008 Sep 17. Erratum In: N Engl J Med. 2009 Feb 5;360(6):648.. Breiman, Robert E [corrected to Breiman, Robert F].
Results Reference
derived
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Mother's Gift Project
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