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Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

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ClinicalTrials.gov Identifier: NCT00710983
Recruitment Status : Unknown
Verified November 2013 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
First Posted : July 8, 2008
Last Update Posted : November 15, 2013
Sponsor:
Information provided by:
Bandim Health Project

Brief Summary:
Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.

Condition or disease Intervention/treatment Phase
Infant, Newborn Healthy Biological: Oral polio vaccine Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth
Study Start Date : July 2008
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A
Oral polio vaccine
Biological: Oral polio vaccine
No Intervention: B
No oral polio vaccine



Primary Outcome Measures :
  1. Mortality by sex

Secondary Outcome Measures :
  1. Morbidity, growth, immunology


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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Normal birth weight, no overt illness or gross malformations -

Exclusion Criteria:


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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710983


Locations
Guinea-Bissau
Bandim Health Project
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
Principal Investigator: Peter Aaby, DMSc Bandim Health Project

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Aaby, Bandim Health Project
ClinicalTrials.gov Identifier: NCT00710983     History of Changes
Other Study ID Numbers: 2008-7041-122
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013

Keywords provided by Bandim Health Project:
Mortality
Morbidity
Growth
Immunology

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs