Trial Outcomes & Findings for Aerosol BCG Challenge Study in Historically BCG-vaccinated Volunteers (NCT NCT04777721)
NCT ID: NCT04777721
Last Updated: 2025-02-06
Results Overview
Quantification of BCG culture by mycobacterial growth indicator tube (PCR quantification and DNA strip assay speciation as required)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 14
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Group 1: 1 x 10^4 Cfu Aerosol Inhaled BCG
3 historically BCG-vaccinated volunteers will receive 1 x 10\^4 cfu aerosol inhaled BCG. All Group 1 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 2: 1 x 10^5 Cfu Aerosol Inhaled BCG
3 historically BCG-vaccinated volunteers will receive 1 x 10\^5 cfu aerosol inhaled BCG. All Group 2 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 3: 1 x 10^6 Cfu Aerosol Inhaled BCG
3 historically BCG-vaccinated volunteers will receive 1 x 10\^6 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 4: 1 x 10^7 Cfu Aerosol Inhaled BCG
3 historically BCG-vaccinated volunteers will receive 1 x 10\^7 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1: 1 x 10^4 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^4 cfu aerosol inhaled BCG. All Group 1 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 2: 1 x 10^5 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^5 cfu aerosol inhaled BCG. All Group 2 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 3: 1 x 10^6 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^6 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 4: 1 x 10^7 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^7 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
12 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
8 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 14Quantification of BCG culture by mycobacterial growth indicator tube (PCR quantification and DNA strip assay speciation as required)
Outcome measures
| Measure |
Group 1: 1 x 10^4 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^4 cfu aerosol inhaled BCG. All Group 1 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 2: 1 x 10^5 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^5 cfu aerosol inhaled BCG. All Group 2 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 3: 1 x 10^6 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^6 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 4: 1 x 10^7 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^7 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
|---|---|---|---|---|
|
To Quantify BCG Recoverable From Bronchial Sample
|
0 Volunteers with detectable BCG
|
0 Volunteers with detectable BCG
|
0 Volunteers with detectable BCG
|
0 Volunteers with detectable BCG
|
SECONDARY outcome
Timeframe: Up to day 168Evaluation of the human clinical response to BCG challenge via collection of data on adverse events at each visit, via diary cards and lung function test results.
Outcome measures
| Measure |
Group 1: 1 x 10^4 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^4 cfu aerosol inhaled BCG. All Group 1 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 2: 1 x 10^5 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^5 cfu aerosol inhaled BCG. All Group 2 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 3: 1 x 10^6 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^6 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 4: 1 x 10^7 Cfu Aerosol Inhaled BCG
n=3 Participants
3 historically BCG-vaccinated volunteers will receive 1 x 10\^7 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
|---|---|---|---|---|
|
Adverse Events
|
3 Number of participants reporting events
|
1 Number of participants reporting events
|
3 Number of participants reporting events
|
3 Number of participants reporting events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 168Laboratory markers of innate and adaptive immunity, determined by ex-vivo ELISpot
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 168Laboratory markers of innate and adaptive immunity, determined by ELISA
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 168Laboratory markers of innate and adaptive immunity, determined by RNA sequence analysis
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 168Laboratory markers of innate and adaptive immunity, determined by intracellular cytokine staining of blood and bronchial samples
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 168Laboratory markers of innate and adaptive immunity, determined by BCG cfu counts and or molecular diagnostics on induced sputum
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 168Laboratory markers of innate and adaptive immunity, determined by matrix from adapted mask collection
Outcome measures
Outcome data not reported
Adverse Events
Group 1: 1 x 10^4 Cfu Aerosol Inhaled BCG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2: 1 x 10^5 Cfu Aerosol Inhaled BCG
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3: 1 x 10^6 Cfu Aerosol Inhaled BCG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4: 1 x 10^7 Cfu Aerosol Inhaled BCG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: 1 x 10^4 Cfu Aerosol Inhaled BCG
n=3 participants at risk
3 historically BCG-vaccinated volunteers will receive 1 x 10\^4 cfu aerosol inhaled BCG. All Group 1 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 2: 1 x 10^5 Cfu Aerosol Inhaled BCG
n=3 participants at risk
3 historically BCG-vaccinated volunteers will receive 1 x 10\^5 cfu aerosol inhaled BCG. All Group 2 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 3: 1 x 10^6 Cfu Aerosol Inhaled BCG
n=3 participants at risk
3 historically BCG-vaccinated volunteers will receive 1 x 10\^6 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
Group 4: 1 x 10^7 Cfu Aerosol Inhaled BCG
n=3 participants at risk
3 historically BCG-vaccinated volunteers will receive 1 x 10\^7 cfu aerosol inhaled BCG. All Group 3 volunteers will have a bronchoscopy 14 days post challenge.
BCG Danish: BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
|
|---|---|---|---|---|
|
General disorders
Night Sweat
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Musculoskeletal and connective tissue disorders
Neck Ache
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Shivers
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Temperature
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
66.7%
2/3 • Number of events 2 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
66.7%
2/3 • Number of events 2 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
100.0%
3/3 • Number of events 3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Feverishness
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
100.0%
3/3 • Number of events 3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Headache
|
66.7%
2/3 • Number of events 2 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
100.0%
3/3 • Number of events 3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
100.0%
3/3 • Number of events 3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Malaise
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
100.0%
3/3 • Number of events 3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Cough
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
100.0%
3/3 • Number of events 3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Sore throat
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
66.7%
2/3 • Number of events 2 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
General disorders
Tickly throat
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
66.7%
2/3 • Number of events 2 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Respiratory, thoracic and mediastinal disorders
Wheeze
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
66.7%
2/3 • Number of events 2 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
33.3%
1/3 • Number of events 1 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Respiratory, thoracic and mediastinal disorders
Cough phlegm
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
66.7%
2/3 • Number of events 2 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Respiratory, thoracic and mediastinal disorders
Chest Tightness
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
66.7%
2/3 • Number of events 2 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Respiratory, thoracic and mediastinal disorders
Cough Blood
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
0.00%
0/3 • Solicited and unsolicited AEs reported within 72 hours of challenge
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place