Trial Outcomes & Findings for Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial (NCT NCT02504203)
NCT ID: NCT02504203
Last Updated: 2026-05-26
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2332 participants
Primary outcome timeframe
60 days after birth
Results posted on
2026-05-26
Participant Flow
Unit of analysis: Clusters
Participant milestones
| Measure |
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1007 46
|
1219 46
|
|
Overall Study
COMPLETED
|
1007 46
|
1219 46
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
Baseline characteristics by cohort
| Measure |
Intervention: BCG and OPV at Home Visits
n=1007 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1219 Participants
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.
|
Total
n=2226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 24 hours
|
541 Participants
n=20 Participants
|
689 Participants
n=32 Participants
|
1230 Participants
n=64 Participants
|
|
Age, Customized
24-47 hours
|
237 Participants
n=20 Participants
|
274 Participants
n=32 Participants
|
511 Participants
n=64 Participants
|
|
Age, Customized
48-71 hours
|
229 Participants
n=20 Participants
|
256 Participants
n=32 Participants
|
485 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
493 Participants
n=20 Participants
|
607 Participants
n=32 Participants
|
1100 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
514 Participants
n=20 Participants
|
612 Participants
n=32 Participants
|
1126 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1007 Participants
n=20 Participants
|
1219 Participants
n=32 Participants
|
2226 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Region of Enrollment
Guinea-Bissau
|
1007 participants
n=20 Participants
|
1219 participants
n=32 Participants
|
2226 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 60 days after birthPopulation: Children entered the analysis on the date of enrolment or 24 hours of age, whichever came last, and remained in the analysis until whatever came first: the first subsequent visit by the BHP team, date of registering first non-trial vaccine after enrolment, death, migration, or 60 days of life.
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.
Outcome measures
| Measure |
Intervention: BCG and OPV at Home Visits
n=1006 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1206 Participants
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.
|
|---|---|---|
|
Non-accidental Mortality
|
7 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 60 days after birthPopulation: Children entered the analysis on the date of enrolment or 24 hours of age, whichever came last, and remained in the analysis until whatever came first: the first subsequent visit by the BHP team, date of registering first non-trial vaccine after enrolment, death, migration, or 60 days of life.
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.
Outcome measures
| Measure |
Intervention: BCG and OPV at Home Visits
n=1006 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1206 Participants
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.
|
|---|---|---|
|
Non-accidental Hospital Admission
|
7 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 60 days after birthPopulation: Children entered the analysis on the date of enrolment or 24 hours of age, whichever came last, and remained in the analysis until whatever came first: the first subsequent visit by the BHP team, date of registering first non-trial vaccine after enrolment, death, migration, or 60 days of life.
Composite outcome of non-accidental mortality and non-accidental hospital admissions
Outcome measures
| Measure |
Intervention: BCG and OPV at Home Visits
n=1006 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1206 Participants
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.
|
|---|---|---|
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Severe Morbidity
|
14 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 60 days after birthPopulation: Same as for the primary outcome
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.
Outcome measures
| Measure |
Intervention: BCG and OPV at Home Visits
n=1006 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1206 Participants
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.
|
|---|---|---|
|
All-cause Consultations
|
101 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 60 days after birthPopulation: Measured at first follow-up visit within 6 months of age.
Development in mid-upper-arm circumference measured using a TALC insertion tape between enrollment and first visit by the BHP team will be assessed.
Outcome measures
| Measure |
Intervention: BCG and OPV at Home Visits
n=834 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1005 Participants
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.
|
|---|---|---|
|
Mid-upper-arm Circumference
|
118 mm
Standard Deviation 14
|
115 mm
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 60 days after birthPopulation: Measured at first follow-up visit within 6 months of age.
Development in weight between enrolment and first visit by the BHP team will be assessed using the WHO Child Growth Standards. These standards were developed using data collected in the WHO Multicentre Growth Reference Study. A child with a weight-for-age Z-score of 0 has a weight-for-age corresponding to the reference mean. A negative z-score indicates that the childs weight-for-age is below the reference mean, while a child with a positive score is above the mean.
Outcome measures
| Measure |
Intervention: BCG and OPV at Home Visits
n=832 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1004 Participants
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.
|
|---|---|---|
|
Weight-for-age Z-score
|
-0.5 Z-score
Standard Deviation 1.08
|
-0.67 Z-score
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 6 months after birthPopulation: All children in the primary analysis, who had their scar status assessed at a follow-up visit
Development of a BCG vaccination scar (yes/no) will be assessed.
Outcome measures
| Measure |
Intervention: BCG and OPV at Home Visits
n=771 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=982 Participants
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.
|
|---|---|---|
|
BCG Scarring
|
734 Participants
|
907 Participants
|
SECONDARY outcome
Timeframe: 60 days after birthPopulation: Reported in DOI: 10.1136/bmjgh-2023-014044: "In the analysis plan, a cost-effectiveness analysis was specified. As the trial was stopped prematurely, we did not perform a cost-effectiveness analysis."
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.
Outcome measures
| Measure |
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
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.
|
|---|---|---|
|
Cost-effectiveness Analysis of Providing BCG at Home-visits
|
0 USD
|
0 USD
|
SECONDARY outcome
Timeframe: 60 days after birthFor every death a verbal autopsy will be made
Outcome measures
| Measure |
Intervention: BCG and OPV at Home Visits
n=1006 Participants
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1206 Participants
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.
|
|---|---|---|
|
Cause Specific Mortality
Respiratory Infection
|
1 Cause of death
|
3 Cause of death
|
|
Cause Specific Mortality
Sepsis
|
3 Cause of death
|
10 Cause of death
|
|
Cause Specific Mortality
Malaria Deaths
|
0 Cause of death
|
1 Cause of death
|
|
Cause Specific Mortality
Gastrointestinal infection
|
0 Cause of death
|
1 Cause of death
|
|
Cause Specific Mortality
Other
|
3 Cause of death
|
13 Cause of death
|
Adverse Events
Intervention: BCG and OPV at Home Visits
Serious events: 14 serious events
Other events: 3 other events
Deaths: 7 deaths
Control: No Vaccines at Home Visits
Serious events: 36 serious events
Other events: 0 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Intervention: BCG and OPV at Home Visits
n=887 participants at risk；n=1006 participants at risk
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1046 participants at risk；n=1206 participants at risk
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.
|
|---|---|---|
|
General disorders
Mortality and Hospital Admission
|
1.4%
14/1006 • Number of events 14 • 6 months
With the exception of Lymphadenitis (Other AE) which is assessed by examining the child, the population at risk is the entire study population. Therefore numbers differ for Other AE and the other outcomes (All-cause mortality, SAE)
|
3.0%
36/1206 • Number of events 43 • 6 months
With the exception of Lymphadenitis (Other AE) which is assessed by examining the child, the population at risk is the entire study population. Therefore numbers differ for Other AE and the other outcomes (All-cause mortality, SAE)
|
Other adverse events
| Measure |
Intervention: BCG and OPV at Home Visits
n=887 participants at risk；n=1006 participants at risk
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.
BCG-Denmark 1331 (Statens Serum Institute): See above
|
Control: No Vaccines at Home Visits
n=1046 participants at risk；n=1206 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.34%
3/887 • 6 months
With the exception of Lymphadenitis (Other AE) which is assessed by examining the child, the population at risk is the entire study population. Therefore numbers differ for Other AE and the other outcomes (All-cause mortality, SAE)
|
0.00%
0/1046 • 6 months
With the exception of Lymphadenitis (Other AE) which is assessed by examining the child, the population at risk is the entire study population. Therefore numbers differ for Other AE and the other outcomes (All-cause mortality, SAE)
|
|
Blood and lymphatic system disorders
Suppurative lymphadenitis
|
0.00%
0/887 • 6 months
With the exception of Lymphadenitis (Other AE) which is assessed by examining the child, the population at risk is the entire study population. Therefore numbers differ for Other AE and the other outcomes (All-cause mortality, SAE)
|
0.00%
0/1046 • 6 months
With the exception of Lymphadenitis (Other AE) which is assessed by examining the child, the population at risk is the entire study population. Therefore numbers differ for Other AE and the other outcomes (All-cause mortality, SAE)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place