Trial Outcomes & Findings for A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV (NCT NCT03213405)
NCT ID: NCT03213405
Last Updated: 2020-12-11
Results Overview
To determine the safety of the rBCG-N-hRSV by evaluating the number of vaccinated participants with adverse events (AEs) due to the vaccination. Among these AEs, the following will be measured: Number of subjects with required AEs grade II, III, and IV, laboratory AEs grade II, III, and IV, and severe AEs (SAEs) considered related to the vaccine. Required AEs included pain, induration, pustule, fever, headache, myalgia, and diarrhea, among others. AEs were collected by self-report on diary cards, study visits, and study phone calls. Laboratory AEs included hematological and biochemical parameters, such as blood counts, transaminases, cholesterol, creatine phosphokinase, and urine analyses, among others. SAEs were defined as any untoward medical occurrence that resulted in death; was life-threatening; required hospitalization; or resulted in disability, among others. Grade 4 laboratory AEs were also considered SAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study)
Results posted on
2020-12-11
Participant Flow
Recruitment was performed in a single center. Recruitment started on 06.27.17 and ended on 12.04.17.
Participant milestones
| Measure |
Conventional BCG Full Dose
Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.
Conventional BCG full dose: 2x10\^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/100 Dose
Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/100: 5x10\^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/10 Dose
Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/10: 5x10\^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV Full Dose
Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV full dose: 1x10\^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV
Baseline characteristics by cohort
| Measure |
Conventional BCG Full Dose
n=6 Participants
Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.
Conventional BCG full dose: 2x10\^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/100 Dose
n=6 Participants
Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/100: 5x10\^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/10 Dose
n=6 Participants
Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/10: 5x10\^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV Full Dose
n=6 Participants
Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV full dose: 1x10\^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
22.0 years
n=5 Participants
|
28.5 years
n=7 Participants
|
24.0 years
n=5 Participants
|
21.0 years
n=4 Participants
|
23.875 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Chile
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Previously vaccinated with BCG
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study)To determine the safety of the rBCG-N-hRSV by evaluating the number of vaccinated participants with adverse events (AEs) due to the vaccination. Among these AEs, the following will be measured: Number of subjects with required AEs grade II, III, and IV, laboratory AEs grade II, III, and IV, and severe AEs (SAEs) considered related to the vaccine. Required AEs included pain, induration, pustule, fever, headache, myalgia, and diarrhea, among others. AEs were collected by self-report on diary cards, study visits, and study phone calls. Laboratory AEs included hematological and biochemical parameters, such as blood counts, transaminases, cholesterol, creatine phosphokinase, and urine analyses, among others. SAEs were defined as any untoward medical occurrence that resulted in death; was life-threatening; required hospitalization; or resulted in disability, among others. Grade 4 laboratory AEs were also considered SAEs.
Outcome measures
| Measure |
Conventional BCG Full Dose
n=6 Participants
Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.
Conventional BCG full dose: 2x10\^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/100 Dose
n=6 Participants
Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/100: 5x10\^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/10 Dose
n=6 Participants
Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/10: 5x10\^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV Full Dose
n=6 Participants
Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV full dose: 1x10\^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
|---|---|---|---|---|
|
Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine.
Required adverse events grade III
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine.
Required adverse events grade IV
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine.
Laboratory adverse events grade II
|
3 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine.
Laboratory adverse events grade III
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine.
Laboratory adverse events grade IV
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine.
Severe adverse events related to the vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine.
Required adverse events grade II
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
Conventional BCG Full Dose
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
rBCG-N-hRSV 1/100 Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
rBCG-N-hRSV 1/10 Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
rBCG-N-hRSV Full Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional BCG Full Dose
n=6 participants at risk
Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.
Conventional BCG full dose: 2x10\^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/100 Dose
n=6 participants at risk
Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/100: 5x10\^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/10 Dose
n=6 participants at risk
Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/10: 5x10\^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV Full Dose
n=6 participants at risk
Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV full dose: 1x10\^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Increase in CPK
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
Other adverse events
| Measure |
Conventional BCG Full Dose
n=6 participants at risk
Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.
Conventional BCG full dose: 2x10\^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/100 Dose
n=6 participants at risk
Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/100: 5x10\^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV 1/10 Dose
n=6 participants at risk
Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV 1/10: 5x10\^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
rBCG-N-hRSV Full Dose
n=6 participants at risk
Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.
rBCG-N-hRSV full dose: 1x10\^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Blood and lymphatic system disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Blood and lymphatic system disorders
Hypernatremia
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Blood and lymphatic system disorders
Increased CPK
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Blood and lymphatic system disorders
Leukocyturia
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Blood and lymphatic system disorders
Increased aspartate aminotransferase
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Pustule at the inoculation site
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
50.0%
3/6 • Number of events 3 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Scab at the inoculation site
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
50.0%
3/6 • Number of events 3 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
83.3%
5/6 • Number of events 5 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Sensitivity at the inoculation site
|
66.7%
4/6 • Number of events 4 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
50.0%
3/6 • Number of events 3 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
33.3%
2/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Erythema at the inoculation site
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Induration at the inoculation site
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Headache
|
100.0%
6/6 • Number of events 13 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
100.0%
6/6 • Number of events 8 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
33.3%
2/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
100.0%
6/6 • Number of events 7 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
50.0%
3/6 • Number of events 6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
33.3%
2/6 • Number of events 3 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
33.3%
2/6 • Number of events 3 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Number of events 7 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
33.3%
2/6 • Number of events 3 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
50.0%
3/6 • Number of events 6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Hypertension
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
General disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 2 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
0.00%
0/6 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
|
16.7%
1/6 • Number of events 1 • Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
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Additional Information
Dr. Alexis Kalergis
Pontificia Universidad Católica de Chile
Phone: +56223541924
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place