Trial Outcomes & Findings for Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection (NCT NCT04152161)

Results Overview

Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1836 participants

Primary outcome timeframe

Up to 48 months

Results posted on

2025-06-19

Participant Flow

This was a Phase IIb, randomized, placebo-controlled, observer-blind study to evaluate the efficacy, safety, and immunogenicity of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus Assay (QFT) negative, healthy adolescents.

A total of 1836 participants were enrolled from South African and were randomized 1:1 to experimental and placebo groups.

Participant milestones

Participant milestones
Measure	Bacille Calmette Guerin (BCG) Group Participants were randomized to receive a single 0.1 milliliter (mL) volume of BCG vaccine Statens Serum Institut (SSI), administered intradermally in deltoid region of the upper arm.	Placebo Group Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Overall Study STARTED	919	917
Overall Study Did Not Receive the Intervention	1	0
Overall Study COMPLETED	110	111
Overall Study NOT COMPLETED	809	806

Reasons for withdrawal

Reasons for withdrawal
Measure	Bacille Calmette Guerin (BCG) Group Participants were randomized to receive a single 0.1 milliliter (mL) volume of BCG vaccine Statens Serum Institut (SSI), administered intradermally in deltoid region of the upper arm.	Placebo Group Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Overall Study Death	0	1
Overall Study Physician Decision	0	1
Overall Study Lost to Follow-up	9	3
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	29	28
Overall Study Sponsor termination of study	750	755
Overall Study Other	20	18

Baseline Characteristics

Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bacille Calmette Guerin (BCG) Group n=918 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=917 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.	Total n=1835 Participants Total of all reporting groups
Age, Continuous	13.4 Years STANDARD_DEVIATION 1.68 • n=93 Participants	13.4 Years STANDARD_DEVIATION 1.67 • n=4 Participants	13.4 Years STANDARD_DEVIATION 1.67 • n=27 Participants
Sex: Female, Male Female	474 Participants n=93 Participants	469 Participants n=4 Participants	943 Participants n=27 Participants
Sex: Female, Male Male	444 Participants n=93 Participants	448 Participants n=4 Participants	892 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	625 Participants n=93 Participants	627 Participants n=4 Participants	1252 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	292 Participants n=93 Participants	290 Participants n=4 Participants	582 Participants n=27 Participants
Race/Ethnicity, Customized Black	729 Participants n=93 Participants	735 Participants n=4 Participants	1464 Participants n=27 Participants
Race/Ethnicity, Customized Asian Indian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Mixed Race	63 Participants n=93 Participants	61 Participants n=4 Participants	124 Participants n=27 Participants
Race/Ethnicity, Customized Southern African Colored	125 Participants n=93 Participants	120 Participants n=4 Participants	245 Participants n=27 Participants
Race/Ethnicity, Customized White	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 48 months

Population: Modified Intention to Treat Efficacy Population comprised of all participants randomly assigned to study intervention who received the study intervention, and are QFT negative at the Day 71 visit, or at the first study visit post Day 71 for which a QFT result is available if the Day 71 study visit was missed or the Day 71 QFT result was not available.

Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.

Outcome measures

Outcome measures
Measure	Bacille Calmette Guerin (BCG) Group n=871 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=849 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results	82 Participants	78 Participants

SECONDARY outcome

Timeframe: 36 Months Follow-up

Population: mITT Population

Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.

Outcome measures

Outcome measures
Measure	Bacille Calmette Guerin (BCG) Group n=871 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=849 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early	74 Participants	73 Participants

SECONDARY outcome

Timeframe: 48 Months Follow-up

Population: mITT Population

Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.

Outcome measures

Outcome measures
Measure	Bacille Calmette Guerin (BCG) Group n=871 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=849 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early	82 Participants	78 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 7

Population: Safety Population.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Solicited AEs were defined as events that participants were specifically asked about and which were noted by participants in the diary card. Solicited AEs included injection site symptoms of injections site pain, redness and swelling and general body symptoms such as headache, fatigue, gastrointestinal symptoms, and fever.

Outcome measures

Outcome measures
Measure	Bacille Calmette Guerin (BCG) Group n=918 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=917 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination Any injection site symptom	754 Participants	381 Participants
Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination Any general body symptom	371 Participants	314 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 28

Population: Safety Population

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary card, as well as solicited AEs that were ongoing at Day 7 after vaccination. Number of Participants With Unsolicited AEs Through 28 Days after vaccination has been presented.

Outcome measures

Outcome measures
Measure	Bacille Calmette Guerin (BCG) Group n=918 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=917 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination	185 Participants	117 Participants

SECONDARY outcome

Timeframe: Up to 6 months

Population: Safety Population

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of Participants reporting SAEs has been presented.

Outcome measures

Outcome measures
Measure	Bacille Calmette Guerin (BCG) Group n=918 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=917 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Number of Participants With Serious Adverse Events (SAEs)	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 6 months

Population: Safety Population

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AE of special interest are AEs that the sponsor closely monitors. The AEs of special interest to be collected and reported include immune system disorders (anaphylactic reaction), general disorders (disseminated BCG disease), infections and infestations (osteomyelitis, suppurative lymphadenitis, injection site abscess), skin and subcutaneous tissue disorders (injection site lupus vulgaris, injection site keloid formation), and bone disorders (osteitis).

Outcome measures

Outcome measures
Measure	Bacille Calmette Guerin (BCG) Group n=918 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=917 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Number of Participants With AEs of Special Interest Injection site abscess	4 Participants	0 Participants
Number of Participants With AEs of Special Interest Suppurative lymphadenitis (Lymphadenitis bacterial)	1 Participants	0 Participants
Number of Participants With AEs of Special Interest Anaphylactic reaction	0 Participants	0 Participants
Number of Participants With AEs of Special Interest Disseminated BCG disease	0 Participants	0 Participants
Number of Participants With AEs of Special Interest Osteomyelitis	0 Participants	0 Participants
Number of Participants With AEs of Special Interest Injection site lupus vulgaris	0 Participants	0 Participants
Number of Participants With AEs of Special Interest Injection site keloid formation	0 Participants	0 Participants
Number of Participants With AEs of Special Interest Osteitis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 48 months

Population: Safety Population

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. When an AE is judged to be serious and related to an investigational product, it is a Serious ADR.

Outcome measures

Outcome measures
Measure	Bacille Calmette Guerin (BCG) Group n=918 Participants Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=917 Participants Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Number of Participants With Serious Adverse Drug Reactions (ADRs)	0 Participants	0 Participants

Adverse Events

Bacille Calmette Guerin (BCG) Group

Serious events: 3 serious events

Other events: 800 other events

Deaths: 0 deaths

Placebo Group

Serious events: 3 serious events

Other events: 540 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Bacille Calmette Guerin (BCG) Group n=918 participants at risk Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=917 participants at risk Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Infections and infestations Sinusitis	0.11% 1/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.00% 0/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Infections and infestations Subperiosteal abscess	0.11% 1/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.00% 0/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Injury, poisoning and procedural complications Intentional overdose	0.11% 1/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.11% 1/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Infections and infestations Meningitis tuberculous	0.00% 0/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.11% 1/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Infections and infestations Appendicitis	0.00% 0/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.11% 1/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Injury, poisoning and procedural complications Fibula fracture	0.11% 1/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.00% 0/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Injury, poisoning and procedural complications Tibia fracture	0.11% 1/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.00% 0/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Injury, poisoning and procedural complications Traumatic haemothorax	0.11% 1/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.00% 0/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.

Other adverse events

Other adverse events
Measure	Bacille Calmette Guerin (BCG) Group n=918 participants at risk Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.	Placebo Group n=917 participants at risk Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Gastrointestinal disorders Gastrointestinal Symptoms	14.8% 136/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	15.3% 140/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
General disorders Injection site swelling	71.6% 657/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	27.0% 248/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
General disorders Injection site pain	2.3% 21/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.00% 0/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
General disorders Injection site erythema	38.0% 349/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	12.1% 111/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
General disorders Fatigue	24.9% 229/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	20.1% 184/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
General disorders Injection site ulcer	2.2% 20/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.00% 0/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
General disorders Pyrexia	1.3% 12/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	0.33% 3/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Infections and infestations Upper respiratory tract infection	0.87% 8/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	1.6% 15/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Nervous system disorders Headache	3.9% 36/918 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.	2.9% 27/917 • Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48. Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.

Additional Information

Study Director

Gates MRI

Phone: +1 857 702 2108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER