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Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial (BCGR)

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ClinicalTrials.gov Identifier: NCT02504203
Recruitment Status : Recruiting
First Posted : July 21, 2015
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Research Center for Vitamins and Vaccines, Statens Serum Institute
Information provided by (Responsible Party):
Bandim Health Project

Brief Summary:
The purpose of this study is to determine whether BCG vaccination shortly after birth can reduce early infant mortality in a rural and an urban setting.

Condition or disease Intervention/treatment Phase
Infant Mortality BCG Biological: BCG-Denmark 1331 (Statens Serum Institute) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6666 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Active Comparator: Intervention: BCG and OPV at home visits
Infants randomised to receive vaccines at home visits shortly after birth will receive one 0.05 ml dose of Mycobacterium bovis BCG live attenuated vaccine (BCG-Denmark 1331 (Statens Serum Institute) or BCG Japan (Japan BCG Laboratory) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG vaccination. For all children, the nurse will perform umbilical cord and skin care, encourage skin-to-skin contact to keep the new-born warm, examine and weigh the child at a home visit shortly after birth.
Biological: BCG-Denmark 1331 (Statens Serum Institute)
See above
Other Name: BCG-Japan (Japan BCG Laboratory)

No Intervention: Control: No vaccines at home visits
For all children, the nurse will perform umbilical cord and skin care, encourage skin-to-skin contact to keep the new-born warm, examine and weigh the child at a home visit shortly after birth. No vaccines will be administered at these home visits for children in the control arm.



Primary Outcome Measures :
  1. Non-accidental mortality [ Time Frame: 60 days after birth ]
    Non-accidental mortality between the home visit and the next follow-up visit by BHP, when all unvaccinated children who are home will be offered BCG or the date of registering a non-trial vaccine or 60 days, whichever comes first.


Secondary Outcome Measures :
  1. Non-accidental hospital admission [ Time Frame: 60 days after birth ]
    Non-accidental hospital admission between the home visit and the next follow-up visit by BHP, when all unvaccinated children who are home will be offered BCG or the date of registering a non-trial vaccine or 60 days, whichever comes first.

  2. Severe morbidity [ Time Frame: 60 days after birth ]
    Composite outcome of non-accidental mortality and non-accidental hospital admissions

  3. All-cause consultations [ Time Frame: 60 days after birth ]
    All-cause out-patient consultation between the home visit and the next follow-up visit by BHP, when all unvaccinated children who are home will be offered BCG or the date of registering a non-trial vaccine or 60 days, whichever comes first.

  4. Mid-upper-arm circumference [ Time Frame: 60 days after birth ]
    Development in mid-upper-arm circumference measured using a TALC insertion tape between enrollment and first visit by the BHP team will be assessed.

  5. Weight-for-age z-score [ Time Frame: 60 days after birth ]
    Development in weight between enrollment and first visit by the BHP team will be assessed using WHO's weight-for-age z-score reference.

  6. BCG scarring [ Time Frame: 6 months after birth ]
    Development of a BCG vaccination scar (yes/no) will be assessed.

  7. Cost-effectiveness analysis of providing BCG at home-visits [ Time Frame: 60 days after birth ]
    A cost effectiveness analysis seeking to measure the cost per death averted using a societal perspective, contrasting the costs of vaccine provision in the present programme and an outreach system as tested in the trial. The costs/savings associated with different rates of consultations and admissions will also be taken into account.

  8. Cause specific mortality [ Time Frame: 60 days after birth ]
    For every death a verbal autopsy will be made



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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• All children registered during pregnancy will be eligible for the study provided they have not yet received BCG at the date of the home visit.

Exclusion Criteria:

  • Children born outside the cluster, and returning more than 72 hours after the delivery
  • Children that the nurse evaluates to die within the next 24 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504203


Contacts
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Contact: Sanne M Thysen, MD +4531127825 samt@ssi.dk
Contact: Ane B Fisker, MD,PhD abf@ssi.dk

Locations
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Guinea-Bissau
Bandim Health Project Recruiting
Bissau, Guinea-Bissau
Contact: Sanne M Thysen, MD    +4531127825    samt@ssi.dk   
Contact: Ane B Fisker, MD,PhD       abf@ssi.dk   
Sponsors and Collaborators
Bandim Health Project
Research Center for Vitamins and Vaccines, Statens Serum Institute
Investigators
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Principal Investigator: Sanne M Thysen, MD Bandim Health Project
Principal Investigator: Ane B Fisker, MD,PhD Bandim Health Project
Principal Investigator: Amabelia Rodrigues, PhD Bandim Health Project
Study Director: Christine S Benn, MD,PhD,DMSc Research Center for Vitamins and Vaccines
Study Director: Peter Aaby, PhD,DMSc Bandim Health Project

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT02504203     History of Changes
Other Study ID Numbers: BCG150501
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Infant Death
Death
Pathologic Processes
Vaccines
Immunologic Factors
Physiological Effects of Drugs