Trial Outcomes & Findings for Study of AERAS-402 in Healthy Infants (NCT NCT01198366)
NCT ID: NCT01198366
Last Updated: 2017-05-08
Results Overview
Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
487 participants
Primary outcome timeframe
Up to 24 months post vaccination
Results posted on
2017-05-08
Participant Flow
Participant milestones
| Measure |
Dose Finding - Group 1
Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer
|
Dose Finding - Group 2
Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 3
Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 4
Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5
Subjects received 3 doses of AERAS-402 (1 X 10\^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5 Placebo
Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
51
|
52
|
140
|
141
|
|
Overall Study
COMPLETED
|
40
|
44
|
43
|
47
|
125
|
128
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
8
|
5
|
15
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of AERAS-402 in Healthy Infants
Baseline characteristics by cohort
| Measure |
Dose Finding - Group 1
n=52 Participants
Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer
|
Dose Finding - Group 2
n=51 Participants
Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 3
n=51 Participants
Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 4
n=52 Participants
Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5
n=140 Participants
Subjects received 3 doses of AERAS-402 (1 X 10\^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5 Placebo
n=141 Participants
Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer
|
Total
n=487 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Age at Study Day 0 in Days
|
145.3 Days
STANDARD_DEVIATION 18.15 • n=5 Participants
|
144.5 Days
STANDARD_DEVIATION 17.83 • n=7 Participants
|
138.6 Days
STANDARD_DEVIATION 19.45 • n=5 Participants
|
149.1 Days
STANDARD_DEVIATION 21.44 • n=4 Participants
|
145.2 Days
STANDARD_DEVIATION 19.98 • n=21 Participants
|
150.2 Days
STANDARD_DEVIATION 20.22 • n=8 Participants
|
146.3 Days
STANDARD_DEVIATION 19.97 • n=8 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
57 Participants
n=8 Participants
|
217 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
84 Participants
n=8 Participants
|
270 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
42 participants
n=5 Participants
|
44 participants
n=7 Participants
|
41 participants
n=5 Participants
|
43 participants
n=4 Participants
|
102 participants
n=21 Participants
|
98 participants
n=8 Participants
|
370 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Coloured
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
38 participants
n=21 Participants
|
43 participants
n=8 Participants
|
117 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
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
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
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
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Region of Enrollment
Mozambique
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
14 participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
70 participants
n=21 Participants
|
70 participants
n=8 Participants
|
188 participants
n=8 Participants
|
|
Region of Enrollment
Kenya
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
36 participants
n=5 Participants
|
36 participants
n=4 Participants
|
70 participants
n=21 Participants
|
71 participants
n=8 Participants
|
285 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 24 months post vaccinationPopulation: Subjects who received at least one vaccination.
Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile
Outcome measures
| Measure |
Dose Finding - Group 1
n=52 Participants
Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer
|
Dose Finding - Group 2
n=51 Participants
Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 3
n=51 Participants
Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 4
n=52 Participants
Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5
n=140 Participants
Subjects received 3 doses of AERAS-402 (1 X 10\^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5 Placebo
n=141 Participants
Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer
|
|---|---|---|---|---|---|---|
|
Adverse Events Collected Per Subject
|
94.2 percentage of subjects with an AE
|
96.1 percentage of subjects with an AE
|
100.0 percentage of subjects with an AE
|
100.0 percentage of subjects with an AE
|
100.0 percentage of subjects with an AE
|
98.6 percentage of subjects with an AE
|
SECONDARY outcome
Timeframe: 28 days post last vaccinationPopulation: Groups 1-4: Subjects who received both vaccinations as randomized. Group 5: Subjects who received all three study vaccinations as randomized.
To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.
Outcome measures
| Measure |
Dose Finding - Group 1
n=41 Participants
Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer
|
Dose Finding - Group 2
n=39 Participants
Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 3
n=42 Participants
Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 4
n=46 Participants
Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5
n=50 Participants
Subjects received 3 doses of AERAS-402 (1 X 10\^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5 Placebo
n=61 Participants
Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer
|
|---|---|---|---|---|---|---|
|
Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects
Ag85A CD4
|
0.00 percentage of Tcell response
Interval 0.0 to 0.0
|
0.01 percentage of Tcell response
Interval 0.0 to 0.03
|
0.02 percentage of Tcell response
Interval 0.01 to 0.03
|
0.02 percentage of Tcell response
Interval 0.01 to 0.04
|
0.02 percentage of Tcell response
Interval 0.01 to 0.04
|
0.00 percentage of Tcell response
Interval 0.0 to 0.01
|
|
Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects
Ag85A CD8
|
0.00 percentage of Tcell response
Interval 0.0 to 0.0
|
0.01 percentage of Tcell response
Interval 0.0 to 0.04
|
0.01 percentage of Tcell response
Interval 0.0 to 0.04
|
0.02 percentage of Tcell response
Interval 0.0 to 0.04
|
0.04 percentage of Tcell response
Interval 0.01 to 0.06
|
0.00 percentage of Tcell response
Interval 0.0 to 0.01
|
|
Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects
Ag85B CD4
|
0.00 percentage of Tcell response
Interval 0.0 to 0.01
|
0.02 percentage of Tcell response
Interval 0.01 to 0.03
|
0.02 percentage of Tcell response
Interval 0.01 to 0.03
|
0.03 percentage of Tcell response
Interval 0.01 to 0.04
|
0.01 percentage of Tcell response
Interval 0.01 to 0.03
|
0.00 percentage of Tcell response
Interval 0.0 to 0.01
|
|
Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects
Ag85B CD8
|
0.00 percentage of Tcell response
Interval 0.0 to 0.01
|
0.04 percentage of Tcell response
Interval 0.02 to 0.08
|
0.03 percentage of Tcell response
Interval 0.01 to 0.05
|
0.04 percentage of Tcell response
Interval 0.02 to 0.07
|
0.05 percentage of Tcell response
Interval 0.03 to 0.07
|
0.00 percentage of Tcell response
Interval 0.0 to 0.0
|
|
Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects
TB10.4 CD4
|
0.01 percentage of Tcell response
Interval 0.0 to 0.01
|
0.01 percentage of Tcell response
Interval 0.0 to 0.01
|
0.01 percentage of Tcell response
Interval 0.0 to 0.03
|
0.01 percentage of Tcell response
Interval 0.01 to 0.02
|
0.01 percentage of Tcell response
Interval 0.0 to 0.01
|
0.00 percentage of Tcell response
Interval 0.0 to 0.01
|
|
Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects
TB10.4 CD8
|
0.00 percentage of Tcell response
Interval 0.0 to 0.01
|
0.01 percentage of Tcell response
Interval 0.0 to 0.01
|
0.00 percentage of Tcell response
Interval 0.0 to 0.01
|
0.01 percentage of Tcell response
Interval 0.0 to 0.02
|
0.01 percentage of Tcell response
Interval 0.0 to 0.01
|
0.00 percentage of Tcell response
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 28 days post last vaccinationPopulation: Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Groups 2 and 3). Group 5: Subjects who received all three study vaccinations as randomized.
To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings.
Outcome measures
| Measure |
Dose Finding - Group 1
n=26 Participants
Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer
|
Dose Finding - Group 2
Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 3
Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 4
n=34 Participants
Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5
n=43 Participants
Subjects received 3 doses of AERAS-402 (1 X 10\^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5 Placebo
n=46 Participants
Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer
|
|---|---|---|---|---|---|---|
|
Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay
Ag85A
|
5.00 SFU/10^6 PBMC
Interval 2.5 to 6.67
|
—
|
—
|
87.92 SFU/10^6 PBMC
Interval 74.17 to 156.67
|
98.33 SFU/10^6 PBMC
Interval 70.0 to 151.67
|
0.00 SFU/10^6 PBMC
Interval 0.0 to 3.33
|
|
Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay
Ag85B
|
0.42 SFU/10^6 PBMC
Interval 0.0 to 5.0
|
—
|
—
|
127.08 SFU/10^6 PBMC
Interval 70.83 to 285.0
|
65.00 SFU/10^6 PBMC
Interval 51.67 to 133.33
|
0.83 SFU/10^6 PBMC
Interval 0.0 to 5.0
|
|
Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay
TB10.4
|
5.42 SFU/10^6 PBMC
Interval 0.83 to 11.67
|
—
|
—
|
26.67 SFU/10^6 PBMC
Interval 19.17 to 49.17
|
17.50 SFU/10^6 PBMC
Interval 11.67 to 28.33
|
3.33 SFU/10^6 PBMC
Interval 1.67 to 6.67
|
SECONDARY outcome
Timeframe: 28 day post last vaccinationPopulation: Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Ag85A and TB10.4). Assays were not done for groups 2 and 3 for any antigen. Group 5: Subjects who received all three study vaccinations as randomized.
To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4).
Outcome measures
| Measure |
Dose Finding - Group 1
n=19 Participants
Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer
|
Dose Finding - Group 2
Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 3
Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 4
n=32 Participants
Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5
n=18 Participants
Subjects received 3 doses of AERAS-402 (1 X 10\^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5 Placebo
n=16 Participants
Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer
|
|---|---|---|---|---|---|---|
|
Antigen-specific Antibody Response - Mean Optical Density (Mean OD)
Ag85A
|
NA Optical Density
This group was not analyzed.
|
—
|
—
|
NA Optical Density
This group was not analyzed.
|
1.34 Optical Density
Interval 1.08 to 2.37
|
0.20 Optical Density
Interval 0.14 to 0.3
|
|
Antigen-specific Antibody Response - Mean Optical Density (Mean OD)
Ag85B
|
0.26 Optical Density
Interval 0.12 to 0.38
|
—
|
—
|
2.15 Optical Density
Interval 1.8 to 2.53
|
2.17 Optical Density
Interval 1.95 to 3.04
|
0.37 Optical Density
Interval 0.28 to 0.72
|
|
Antigen-specific Antibody Response - Mean Optical Density (Mean OD)
TB10.4
|
NA Optical Density
This group was not analyzed.
|
—
|
—
|
NA Optical Density
This group was not analyzed.
|
0.94 Optical Density
Interval 0.39 to 1.5
|
0.34 Optical Density
Interval 0.25 to 0.46
|
SECONDARY outcome
Timeframe: up to 24 months post vaccinationPopulation: Subjects who received at least one vaccination and had results at baseline and end of study.
To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on \>= 0.35IU/mL was considered positive for this study.
Outcome measures
| Measure |
Dose Finding - Group 1
n=38 Participants
Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer
|
Dose Finding - Group 2
n=44 Participants
Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 3
n=43 Participants
Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Dose Finding - Group 4
n=47 Participants
Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5
n=124 Participants
Subjects received 3 doses of AERAS-402 (1 X 10\^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
|
Expanded Safety Phase - Group 5 Placebo
n=128 Participants
Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination
|
0 % converting from QFT neg to pos
|
13.6 % converting from QFT neg to pos
|
0 % converting from QFT neg to pos
|
4.3 % converting from QFT neg to pos
|
2.4 % converting from QFT neg to pos
|
4.7 % converting from QFT neg to pos
|
Adverse Events
Dose Finding - Group 1
Serious events: 20 serious events
Other events: 48 other events
Deaths: 0 deaths
Dose Finding - Group 2
Serious events: 25 serious events
Other events: 47 other events
Deaths: 0 deaths
Dose Finding - Group 3
Serious events: 23 serious events
Other events: 49 other events
Deaths: 0 deaths
Dose Finding - Group 4
Serious events: 18 serious events
Other events: 52 other events
Deaths: 0 deaths
Expanded Safety Phase - Group 5
Serious events: 40 serious events
Other events: 136 other events
Deaths: 0 deaths
Expanded Safety Phase - Group 5 Placebo
Serious events: 38 serious events
Other events: 139 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Finding - Group 1
n=52 participants at risk
Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.
|
Dose Finding - Group 2
n=51 participants at risk
Subjects received two doses of AERAS-402 (1.5 x 10\^10 vp) on study days 0 and 28.
|
Dose Finding - Group 3
n=51 participants at risk
Subjects received two doses of AERAS-402 (3.0 x 10\^10 vp) on study days 0 and 28.
|
Dose Finding - Group 4
n=52 participants at risk
Subjects received two doses of AERAS-402 (1.0 x 10\^11 vp) on study days 0 and 28.
|
Expanded Safety Phase - Group 5
n=140 participants at risk
Subjects received 3 doses of AERAS-402 (1.0 X 10\^11 vp) on days 0, 28 and 280.
|
Expanded Safety Phase - Group 5 Placebo
n=141 participants at risk
Subjects received 3 doses of placebo (sterile buffer) on days 0, 28 and 280.
Placebo
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
2.0%
1/51 • Number of events 4 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
1.4%
2/140 • Number of events 2 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Bronchitis
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
1.4%
2/140 • Number of events 2 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Burn infection
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.71%
1/140 • Number of events 1 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Croup infectious
|
0.00%
0/52 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Gastroenteritis
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
3.9%
2/51 • Number of events 3 • Up to 24 months
|
13.7%
7/51 • Number of events 7 • Up to 24 months
|
7.7%
4/52 • Number of events 4 • Up to 24 months
|
5.7%
8/140 • Number of events 8 • Up to 24 months
|
7.8%
11/141 • Number of events 14 • Up to 24 months
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/52 • Up to 24 months
|
3.9%
2/51 • Number of events 2 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Malaria
|
23.1%
12/52 • Number of events 16 • Up to 24 months
|
35.3%
18/51 • Number of events 22 • Up to 24 months
|
21.6%
11/51 • Number of events 13 • Up to 24 months
|
15.4%
8/52 • Number of events 12 • Up to 24 months
|
10.0%
14/140 • Number of events 16 • Up to 24 months
|
8.5%
12/141 • Number of events 18 • Up to 24 months
|
|
Infections and infestations
Measles
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
1.4%
2/140 • Number of events 2 • Up to 24 months
|
2.8%
4/141 • Number of events 4 • Up to 24 months
|
|
Infections and infestations
Meningitis
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.71%
1/140 • Number of events 1 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Pneumonia
|
19.2%
10/52 • Number of events 12 • Up to 24 months
|
13.7%
7/51 • Number of events 9 • Up to 24 months
|
11.8%
6/51 • Number of events 6 • Up to 24 months
|
11.5%
6/52 • Number of events 6 • Up to 24 months
|
7.9%
11/140 • Number of events 13 • Up to 24 months
|
3.5%
5/141 • Number of events 5 • Up to 24 months
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/52 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Salmonella bacteraemia
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/52 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Staphylococcal scalded skin syndrome
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
1.4%
2/141 • Number of events 2 • Up to 24 months
|
|
Infections and infestations
Varicella
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.71%
1/140 • Number of events 1 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
1.4%
2/141 • Number of events 3 • Up to 24 months
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
2.9%
4/140 • Number of events 4 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/52 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.71%
1/140 • Number of events 1 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Congenital, familial and genetic disorders
Brain malformation
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
General disorders
Pyrexia
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
1.4%
2/140 • Number of events 2 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
General disorders
Sudden death
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Investigations
Haemoglobin decreased
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.71%
1/140 • Number of events 1 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
2.1%
3/141 • Number of events 3 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
2.9%
4/140 • Number of events 4 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
Other adverse events
| Measure |
Dose Finding - Group 1
n=52 participants at risk
Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.
|
Dose Finding - Group 2
n=51 participants at risk
Subjects received two doses of AERAS-402 (1.5 x 10\^10 vp) on study days 0 and 28.
|
Dose Finding - Group 3
n=51 participants at risk
Subjects received two doses of AERAS-402 (3.0 x 10\^10 vp) on study days 0 and 28.
|
Dose Finding - Group 4
n=52 participants at risk
Subjects received two doses of AERAS-402 (1.0 x 10\^11 vp) on study days 0 and 28.
|
Expanded Safety Phase - Group 5
n=140 participants at risk
Subjects received 3 doses of AERAS-402 (1.0 X 10\^11 vp) on days 0, 28 and 280.
|
Expanded Safety Phase - Group 5 Placebo
n=141 participants at risk
Subjects received 3 doses of placebo (sterile buffer) on days 0, 28 and 280.
Placebo
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
3.9%
2/51 • Number of events 2 • Up to 24 months
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
2.9%
4/140 • Number of events 5 • Up to 24 months
|
1.4%
2/141 • Number of events 3 • Up to 24 months
|
|
Infections and infestations
Folliculitis
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
6.4%
9/140 • Number of events 14 • Up to 24 months
|
8.5%
12/141 • Number of events 12 • Up to 24 months
|
|
Infections and infestations
Gastroenteritis
|
11.5%
6/52 • Number of events 6 • Up to 24 months
|
7.8%
4/51 • Number of events 4 • Up to 24 months
|
7.8%
4/51 • Number of events 4 • Up to 24 months
|
19.2%
10/52 • Number of events 11 • Up to 24 months
|
17.1%
24/140 • Number of events 25 • Up to 24 months
|
14.2%
20/141 • Number of events 21 • Up to 24 months
|
|
Infections and infestations
Malaria
|
25.0%
13/52 • Number of events 14 • Up to 24 months
|
35.3%
18/51 • Number of events 21 • Up to 24 months
|
33.3%
17/51 • Number of events 21 • Up to 24 months
|
32.7%
17/52 • Number of events 22 • Up to 24 months
|
24.3%
34/140 • Number of events 50 • Up to 24 months
|
24.8%
35/141 • Number of events 48 • Up to 24 months
|
|
Infections and infestations
Measles
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
3.6%
5/140 • Number of events 5 • Up to 24 months
|
6.4%
9/141 • Number of events 9 • Up to 24 months
|
|
Infections and infestations
Oral candidiasis
|
7.7%
4/52 • Number of events 4 • Up to 24 months
|
9.8%
5/51 • Number of events 5 • Up to 24 months
|
5.9%
3/51 • Number of events 4 • Up to 24 months
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
3.6%
5/140 • Number of events 6 • Up to 24 months
|
2.1%
3/141 • Number of events 3 • Up to 24 months
|
|
Infections and infestations
Pneumonia
|
25.0%
13/52 • Number of events 20 • Up to 24 months
|
13.7%
7/51 • Number of events 7 • Up to 24 months
|
15.7%
8/51 • Number of events 12 • Up to 24 months
|
34.6%
18/52 • Number of events 25 • Up to 24 months
|
18.6%
26/140 • Number of events 30 • Up to 24 months
|
14.2%
20/141 • Number of events 21 • Up to 24 months
|
|
Infections and infestations
Rhinitis
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
3.9%
2/51 • Number of events 2 • Up to 24 months
|
7.8%
4/51 • Number of events 5 • Up to 24 months
|
15.4%
8/52 • Number of events 8 • Up to 24 months
|
4.3%
6/140 • Number of events 7 • Up to 24 months
|
4.3%
6/141 • Number of events 6 • Up to 24 months
|
|
Infections and infestations
Tinea capitis
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
59.6%
31/52 • Number of events 47 • Up to 24 months
|
62.7%
32/51 • Number of events 46 • Up to 24 months
|
70.6%
36/51 • Number of events 55 • Up to 24 months
|
71.2%
37/52 • Number of events 55 • Up to 24 months
|
83.6%
117/140 • Number of events 248 • Up to 24 months
|
80.9%
114/141 • Number of events 214 • Up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
11.5%
6/52 • Number of events 7 • Up to 24 months
|
5.9%
3/51 • Number of events 3 • Up to 24 months
|
7.8%
4/51 • Number of events 4 • Up to 24 months
|
9.6%
5/52 • Number of events 5 • Up to 24 months
|
11.4%
16/140 • Number of events 16 • Up to 24 months
|
13.5%
19/141 • Number of events 19 • Up to 24 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.5%
6/52 • Number of events 6 • Up to 24 months
|
11.8%
6/51 • Number of events 7 • Up to 24 months
|
7.8%
4/51 • Number of events 6 • Up to 24 months
|
11.5%
6/52 • Number of events 6 • Up to 24 months
|
33.6%
47/140 • Number of events 77 • Up to 24 months
|
34.0%
48/141 • Number of events 70 • Up to 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
5.9%
3/51 • Number of events 4 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
1.4%
2/140 • Number of events 2 • Up to 24 months
|
0.71%
1/141 • Number of events 1 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypophagia
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
3.9%
2/51 • Number of events 2 • Up to 24 months
|
5.9%
3/51 • Number of events 3 • Up to 24 months
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
5.9%
3/51 • Number of events 3 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
3.6%
5/140 • Number of events 5 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Eye disorders
Conjunctivitis
|
9.6%
5/52 • Number of events 5 • Up to 24 months
|
15.7%
8/51 • Number of events 9 • Up to 24 months
|
23.5%
12/51 • Number of events 13 • Up to 24 months
|
19.2%
10/52 • Number of events 10 • Up to 24 months
|
21.4%
30/140 • Number of events 36 • Up to 24 months
|
14.2%
20/141 • Number of events 26 • Up to 24 months
|
|
Eye disorders
Eye discharge
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
3.9%
2/51 • Number of events 3 • Up to 24 months
|
7.8%
4/51 • Number of events 6 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
2.1%
3/140 • Number of events 3 • Up to 24 months
|
2.8%
4/141 • Number of events 5 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
3/52 • Number of events 5 • Up to 24 months
|
7.8%
4/51 • Number of events 5 • Up to 24 months
|
7.8%
4/51 • Number of events 6 • Up to 24 months
|
7.7%
4/52 • Number of events 5 • Up to 24 months
|
2.1%
3/140 • Number of events 3 • Up to 24 months
|
2.1%
3/141 • Number of events 3 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
5.9%
3/51 • Number of events 3 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.71%
1/140 • Number of events 1 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
4/52 • Number of events 4 • Up to 24 months
|
9.8%
5/51 • Number of events 5 • Up to 24 months
|
13.7%
7/51 • Number of events 7 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
2.9%
4/140 • Number of events 5 • Up to 24 months
|
2.8%
4/141 • Number of events 4 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
61.5%
32/52 • Number of events 51 • Up to 24 months
|
54.9%
28/51 • Number of events 52 • Up to 24 months
|
60.8%
31/51 • Number of events 51 • Up to 24 months
|
57.7%
30/52 • Number of events 42 • Up to 24 months
|
43.6%
61/140 • Number of events 102 • Up to 24 months
|
39.7%
56/141 • Number of events 96 • Up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
55.8%
29/52 • Number of events 49 • Up to 24 months
|
58.8%
30/51 • Number of events 53 • Up to 24 months
|
58.8%
30/51 • Number of events 50 • Up to 24 months
|
53.8%
28/52 • Number of events 46 • Up to 24 months
|
62.1%
87/140 • Number of events 151 • Up to 24 months
|
50.4%
71/141 • Number of events 103 • Up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
5/52 • Number of events 6 • Up to 24 months
|
21.6%
11/51 • Number of events 11 • Up to 24 months
|
11.8%
6/51 • Number of events 7 • Up to 24 months
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
5.0%
7/140 • Number of events 7 • Up to 24 months
|
0.71%
1/141 • Number of events 2 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
9.8%
5/51 • Number of events 5 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
8.6%
12/140 • Number of events 12 • Up to 24 months
|
10.6%
15/141 • Number of events 16 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
13/52 • Number of events 17 • Up to 24 months
|
21.6%
11/51 • Number of events 12 • Up to 24 months
|
23.5%
12/51 • Number of events 13 • Up to 24 months
|
17.3%
9/52 • Number of events 9 • Up to 24 months
|
20.0%
28/140 • Number of events 32 • Up to 24 months
|
27.7%
39/141 • Number of events 48 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
9.8%
5/51 • Number of events 5 • Up to 24 months
|
5.9%
3/51 • Number of events 3 • Up to 24 months
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
0.71%
1/140 • Number of events 1 • Up to 24 months
|
2.1%
3/141 • Number of events 3 • Up to 24 months
|
|
General disorders
Fatigue
|
15.4%
8/52 • Number of events 10 • Up to 24 months
|
15.7%
8/51 • Number of events 8 • Up to 24 months
|
23.5%
12/51 • Number of events 12 • Up to 24 months
|
30.8%
16/52 • Number of events 19 • Up to 24 months
|
28.6%
40/140 • Number of events 59 • Up to 24 months
|
11.3%
16/141 • Number of events 22 • Up to 24 months
|
|
General disorders
Feeling hot
|
7.7%
4/52 • Number of events 4 • Up to 24 months
|
7.8%
4/51 • Number of events 5 • Up to 24 months
|
9.8%
5/51 • Number of events 5 • Up to 24 months
|
30.8%
16/52 • Number of events 20 • Up to 24 months
|
26.4%
37/140 • Number of events 43 • Up to 24 months
|
12.8%
18/141 • Number of events 19 • Up to 24 months
|
|
General disorders
Hypothermia
|
1.9%
1/52 • Number of events 2 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
0.00%
0/140 • Up to 24 months
|
0.00%
0/141 • Up to 24 months
|
|
General disorders
Injection site erythema
|
0.00%
0/52 • Up to 24 months
|
5.9%
3/51 • Number of events 5 • Up to 24 months
|
7.8%
4/51 • Number of events 4 • Up to 24 months
|
21.2%
11/52 • Number of events 13 • Up to 24 months
|
21.4%
30/140 • Number of events 42 • Up to 24 months
|
3.5%
5/141 • Number of events 5 • Up to 24 months
|
|
General disorders
Injection site pain
|
11.5%
6/52 • Number of events 7 • Up to 24 months
|
29.4%
15/51 • Number of events 17 • Up to 24 months
|
47.1%
24/51 • Number of events 28 • Up to 24 months
|
71.2%
37/52 • Number of events 54 • Up to 24 months
|
74.3%
104/140 • Number of events 191 • Up to 24 months
|
16.3%
23/141 • Number of events 28 • Up to 24 months
|
|
General disorders
Injection site swelling
|
11.5%
6/52 • Number of events 6 • Up to 24 months
|
27.5%
14/51 • Number of events 19 • Up to 24 months
|
17.6%
9/51 • Number of events 9 • Up to 24 months
|
32.7%
17/52 • Number of events 22 • Up to 24 months
|
32.9%
46/140 • Number of events 60 • Up to 24 months
|
8.5%
12/141 • Number of events 14 • Up to 24 months
|
|
General disorders
Pyrexia
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
11.8%
6/51 • Number of events 6 • Up to 24 months
|
13.7%
7/51 • Number of events 7 • Up to 24 months
|
25.0%
13/52 • Number of events 13 • Up to 24 months
|
42.9%
60/140 • Number of events 76 • Up to 24 months
|
13.5%
19/141 • Number of events 22 • Up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
9.6%
5/52 • Number of events 5 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
6.4%
9/140 • Number of events 10 • Up to 24 months
|
3.5%
5/141 • Number of events 5 • Up to 24 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/52 • Up to 24 months
|
3.9%
2/51 • Number of events 2 • Up to 24 months
|
7.8%
4/51 • Number of events 4 • Up to 24 months
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
2.1%
3/140 • Number of events 3 • Up to 24 months
|
6.4%
9/141 • Number of events 10 • Up to 24 months
|
|
Investigations
Blood bilirubin increased
|
26.9%
14/52 • Number of events 15 • Up to 24 months
|
23.5%
12/51 • Number of events 12 • Up to 24 months
|
37.3%
19/51 • Number of events 20 • Up to 24 months
|
23.1%
12/52 • Number of events 16 • Up to 24 months
|
25.0%
35/140 • Number of events 37 • Up to 24 months
|
19.9%
28/141 • Number of events 34 • Up to 24 months
|
|
Investigations
Eosinophil count increased
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
9.3%
13/140 • Number of events 15 • Up to 24 months
|
6.4%
9/141 • Number of events 10 • Up to 24 months
|
|
Investigations
Haemoglobin decreased
|
23.1%
12/52 • Number of events 15 • Up to 24 months
|
17.6%
9/51 • Number of events 9 • Up to 24 months
|
17.6%
9/51 • Number of events 9 • Up to 24 months
|
36.5%
19/52 • Number of events 19 • Up to 24 months
|
25.7%
36/140 • Number of events 38 • Up to 24 months
|
22.7%
32/141 • Number of events 37 • Up to 24 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/52 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
2.1%
3/140 • Number of events 3 • Up to 24 months
|
5.7%
8/141 • Number of events 10 • Up to 24 months
|
|
Investigations
Lymphocyte count increased
|
21.2%
11/52 • Number of events 11 • Up to 24 months
|
23.5%
12/51 • Number of events 12 • Up to 24 months
|
31.4%
16/51 • Number of events 16 • Up to 24 months
|
17.3%
9/52 • Number of events 9 • Up to 24 months
|
5.7%
8/140 • Number of events 8 • Up to 24 months
|
5.7%
8/141 • Number of events 8 • Up to 24 months
|
|
Investigations
Neutrophil count decreased
|
11.5%
6/52 • Number of events 6 • Up to 24 months
|
13.7%
7/51 • Number of events 7 • Up to 24 months
|
7.8%
4/51 • Number of events 4 • Up to 24 months
|
13.5%
7/52 • Number of events 8 • Up to 24 months
|
12.9%
18/140 • Number of events 20 • Up to 24 months
|
14.9%
21/141 • Number of events 24 • Up to 24 months
|
|
Investigations
Platelet count decreased
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
3.9%
2/51 • Number of events 3 • Up to 24 months
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
4.3%
6/140 • Number of events 6 • Up to 24 months
|
6.4%
9/141 • Number of events 9 • Up to 24 months
|
|
Investigations
Platelet count increased
|
13.5%
7/52 • Number of events 7 • Up to 24 months
|
19.6%
10/51 • Number of events 10 • Up to 24 months
|
19.6%
10/51 • Number of events 10 • Up to 24 months
|
13.5%
7/52 • Number of events 7 • Up to 24 months
|
7.9%
11/140 • Number of events 11 • Up to 24 months
|
2.1%
3/141 • Number of events 3 • Up to 24 months
|
|
Investigations
Protein urine
|
7.7%
4/52 • Number of events 4 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
5.8%
3/52 • Number of events 3 • Up to 24 months
|
2.9%
4/140 • Number of events 5 • Up to 24 months
|
5.7%
8/141 • Number of events 8 • Up to 24 months
|
|
Investigations
White blood cell count decreased
|
1.9%
1/52 • Number of events 1 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
3.9%
2/51 • Number of events 2 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
2.1%
3/140 • Number of events 3 • Up to 24 months
|
7.8%
11/141 • Number of events 11 • Up to 24 months
|
|
Investigations
White blood cell count increased
|
7.7%
4/52 • Number of events 4 • Up to 24 months
|
2.0%
1/51 • Number of events 1 • Up to 24 months
|
9.8%
5/51 • Number of events 5 • Up to 24 months
|
0.00%
0/52 • Up to 24 months
|
2.1%
3/140 • Number of events 3 • Up to 24 months
|
4.3%
6/141 • Number of events 6 • Up to 24 months
|
|
Investigations
White blood cells urine
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
5.9%
3/51 • Number of events 3 • Up to 24 months
|
0.00%
0/51 • Up to 24 months
|
3.8%
2/52 • Number of events 2 • Up to 24 months
|
3.6%
5/140 • Number of events 5 • Up to 24 months
|
2.1%
3/141 • Number of events 3 • Up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place