Study Stopped
Due to fewer than expected children enrolled and lower than expected overall mortality rate.
Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
BCGR
1 other identifier
interventional
2,332
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 4, 2022
February 1, 2022
5.6 years
July 20, 2015
February 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Non-accidental mortality
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.
60 days after birth
Secondary Outcomes (8)
Non-accidental hospital admission
60 days after birth
Severe morbidity
60 days after birth
All-cause consultations
60 days after birth
Mid-upper-arm circumference
60 days after birth
Weight-for-age z-score
60 days after birth
- +3 more secondary outcomes
Study Arms (2)
Intervention: BCG and OPV at home visits
ACTIVE COMPARATORInfants 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.
Control: No vaccines at home visits
NO INTERVENTIONFor 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.
Interventions
See above
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bandim Health Project
Bissau, Guinea-Bissau
Related Publications (5)
Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
PMID: 21673035BACKGROUNDBiering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.
PMID: 22189537BACKGROUNDThysen SM, Byberg S, Pedersen M, Rodrigues A, Ravn H, Martins C, Benn CS, Aaby P, Fisker AB. BCG coverage and barriers to BCG vaccination in Guinea-Bissau: an observational study. BMC Public Health. 2014 Oct 4;14:1037. doi: 10.1186/1471-2458-14-1037.
PMID: 25282475BACKGROUNDThysen SM, da Silva Borges I, Martins J, Stjernholm AD, Hansen JS, da Silva LMV, Martins JSD, Jensen A, Rodrigues A, Aaby P, Stabell Benn C, Fisker AB. Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau. BMJ Glob Health. 2024 Feb 12;9(2):e014044. doi: 10.1136/bmjgh-2023-014044.
PMID: 38350670DERIVEDThysen SM, Jensen AKG, Rodrigues A, Borges IDS, Aaby P, Benn C, Fisker A. Can earlier BCG vaccination reduce early infant mortality? Study protocol for a cluster randomised trial in Guinea-Bissau. BMJ Open. 2019 Sep 24;9(9):e025724. doi: 10.1136/bmjopen-2018-025724.
PMID: 31551370DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanne M Thysen, MD, PhD
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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 21, 2015
Study Start
November 1, 2015
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
February 4, 2022
Record last verified: 2022-02