Mother's Gift Project
June 21, 2011 updated by: Johns Hopkins Bloomberg School of Public Health
Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
680
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dhaka, Bangladesh
- Icddrb
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
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local and systemic reactions within 2 weeks of vaccination
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Secondary Outcome Measures
Outcome Measure |
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Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: M C Steinhoff, MD, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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].
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
August 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26748
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.