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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03400878
Date of registration:	28/11/2017
Prospective Registration:	No
Primary sponsor:	Bandim Health Project
Public title:	Comparing Morbidity and Mortality Effects of Two Different Strains of BCG
Scientific title:	Evaluating the Non-specific Effects of Different BCG Strains in Guinea-Bissau: Randomized Trial of the Impact on Early-life Hospital Admissions and Deaths
Date of first enrolment:	October 14, 2017
Target sample size:	17505
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT03400878
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Care Provider, Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
Guinea-Bissau

Contacts

Name:	Peter Aaby, Professor
Address:
Telephone:
Email:
Affiliation:	Bandim Health Project

Key inclusion & exclusion criteria

Inclusion criteria:

Newborn, unvaccinated infants identified at the maternity ward and ready to be discharged

Exclusion criteria:

Infants above 6 weeks (>42 days) of age; Infants with gross malformation; Infants that are
acutely ill

Age minimum: N/A
Age maximum: 42 Days
Gender: All

Health Condition(s) or Problem(s) studied

Vaccine Reaction

Trained Immunity

Infant Morbidity

Infant Mortality

Heterologous Immunity

Vaccine Adverse Reaction

Intervention(s)

Biological: BCG-Japan

Biological: BCG-Russia

Primary Outcome(s)

Hospital admission at National Hospital Simão Mendes Pediatric Ward [Time Frame: 6 weeks]

Secondary Outcome(s)

Hospital admission at National Hospital Simão Mendes' Pediatric Ward, stratified by parental BCG scar status [Time Frame: 6 months]

In-hospital case-fatality rate at Pediatric Ward [Time Frame: 6 months]

Hospital admission at National Hospital Simão Mendes' Pediatric Ward, stratified by parental BCG scar status [Time Frame: 6 weeks]

Hospital admission at National Hospital Simão Mendes Pediatric Ward [Time Frame: 6 months]

In-hospital case-fatality rate at National Hospital Simão Mendes' Pediatric Ward, stratified by parental BCG scar status [Time Frame: 6 months]

In-hospital case-fatality rate at National Hospital Simão Mendes' Pediatric Ward, stratified by parental BCG scar status [Time Frame: 6 weeks]

Mortality [Time Frame: 6 weeks]

In-hospital case-fatality rate at National Hospital Simão Mendes Pediatric Ward [Time Frame: 6 weeks]

Mortality [Time Frame: 6 months]

Mortality, stratified by parental BCG scar status [Time Frame: 6 months]

Mortality, stratified by parental BCG scar status [Time Frame: 6 weeks]

Secondary ID(s)

BCGSTRAIN II

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Research Center for Vitamins and Vaccines

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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