Trial Outcomes & Findings for Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults (NCT NCT03965962)
NCT ID: NCT03965962
Last Updated: 2025-09-18
Results Overview
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
640 participants
Primary outcome timeframe
Day 28
Results posted on
2025-09-18
Participant Flow
The study was conducted at 2 active centers in France.
A total of 640 participants were enrolled in the study. Data presented in the disposition table (all milestones) is based on randomized group, except for safety analysis set (SafAS) milestone which is presented based on the actual vaccination group.
Participant milestones
| Measure |
Group 1 VRVg-2+HRIG
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
320
|
107
|
107
|
106
|
|
Overall Study
Vaccination 1 (Day 0)
|
318
|
107
|
107
|
106
|
|
Overall Study
Vaccination 2 (Day 3)
|
317
|
104
|
107
|
106
|
|
Overall Study
Vaccination 3 (Day 7)
|
311
|
103
|
105
|
105
|
|
Overall Study
Vaccination 4 (Day 14)
|
301
|
101
|
101
|
103
|
|
Overall Study
Vaccination 5 (Day 28)
|
294
|
98
|
97
|
98
|
|
Overall Study
Safety Analysis Set (SafAS)
|
320
|
107
|
107
|
104
|
|
Overall Study
COMPLETED
|
295
|
102
|
97
|
100
|
|
Overall Study
NOT COMPLETED
|
25
|
5
|
10
|
6
|
Reasons for withdrawal
| Measure |
Group 1 VRVg-2+HRIG
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
21
|
4
|
10
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
1
|
Baseline Characteristics
Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults
Baseline characteristics by cohort
| Measure |
Group 1 VRVg-2+HRIG
n=320 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=107 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=107 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=106 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
Total Title
n=640 Participants
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 15.0 • n=4 Participants
|
46.1 years
STANDARD_DEVIATION 14.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
382 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
258 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
301 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
612 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Analysis was performed on the per-protocol analysis set (PPAS) that included all participants who received at least 1 dose of the study vaccines. The participants who presented protocol deviations, met PPAS exclusion criteria were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Groups 1, 2, and 3.
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=239 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=77 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=78 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Immune response of VRVg-2 was considered sufficient if the lower limit of the 95% CI for percentage of participants in Group 1 with RVNA titers \>=0.5 IU/mL was not less than 95% at Day 28, when the primary non-inferiority objective was achieved at Day 28.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=239 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=77 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=78 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=77 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
Day 0
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.6
|
0 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
Day 14
|
92.5 percentage of participants
Interval 88.1 to 95.6
|
88.0 percentage of participants
Interval 78.4 to 94.4
|
94.1 percentage of participants
Interval 85.6 to 98.4
|
97.1 percentage of participants
Interval 89.9 to 99.6
|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
Day 28
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
Day 42
|
100 percentage of participants
Interval 98.4 to 100.0
|
100 percentage of participants
Interval 95.1 to 100.0
|
98.7 percentage of participants
Interval 92.9 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Lower limit of quantitation (LLOQ) for the RFFIT assay was 0.2 IU/mL.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=239 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=77 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=78 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=77 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
Day 0
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.6
|
0 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
Day 14
|
99.5 percentage of participants
Interval 97.4 to 100.0
|
100 percentage of participants
Interval 95.2 to 100.0
|
98.5 percentage of participants
Interval 92.1 to 100.0
|
100 percentage of participants
Interval 94.8 to 100.0
|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
Day 28
|
100 percentage of participants
Interval 98.5 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
Day 42
|
100 percentage of participants
Interval 98.4 to 100.0
|
100 percentage of participants
Interval 95.1 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=239 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=77 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=78 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=77 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
Day 0
|
0.100 IU/mL
Interval 0.1 to 0.101
|
0.100 IU/mL
Upper and lower limits of 95% CI were not estimable because all the participants had same value and no variability was observed.
|
0.100 IU/mL
Upper and lower limits of 95% CI were not estimable because all the participants had same value and no variability was observed.
|
0.101 IU/mL
Interval 0.099 to 0.102
|
|
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
Day 14
|
2.40 IU/mL
Interval 2.09 to 2.76
|
1.86 IU/mL
Interval 1.44 to 2.41
|
1.83 IU/mL
Interval 1.46 to 2.28
|
5.41 IU/mL
Interval 4.24 to 6.9
|
|
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
Day 28
|
6.49 IU/mL
Interval 5.75 to 7.34
|
5.03 IU/mL
Interval 3.94 to 6.44
|
5.51 IU/mL
Interval 4.35 to 6.96
|
12.4 IU/mL
Interval 10.5 to 14.5
|
|
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
Day 42
|
13.6 IU/mL
Interval 12.3 to 15.0
|
9.47 IU/mL
Interval 7.96 to 11.3
|
10.7 IU/mL
Interval 8.97 to 12.7
|
19.8 IU/mL
Interval 17.5 to 22.5
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post vaccination (i.e., on Day 14, 28 and Day 42) and pre-vaccination on Day 0.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=239 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=77 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=78 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=77 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
Day 14/Day 0
|
24.0 ratio
Interval 20.8 to 27.6
|
18.6 ratio
Interval 14.4 to 24.1
|
18.3 ratio
Interval 14.6 to 22.8
|
53.7 ratio
Interval 42.1 to 68.4
|
|
Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
Day 28/Day 0
|
64.8 ratio
Interval 57.3 to 73.2
|
50.3 ratio
Interval 39.4 to 64.4
|
55.1 ratio
Interval 43.5 to 69.6
|
123 ratio
Interval 105.0 to 144.0
|
|
Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
Day 42/Day 0
|
135 ratio
Interval 122.0 to 149.0
|
94.7 ratio
Interval 79.6 to 113.0
|
107 ratio
Interval 89.7 to 127.0
|
197 ratio
Interval 173.0 to 224.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=239 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=77 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=78 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=77 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Day 0: Complete Neutralization
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
0 percentage of participants
Interval 0.0 to 4.9
|
0 percentage of participants
Interval 0.0 to 5.0
|
1.4 percentage of participants
Interval 0.0 to 7.3
|
|
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Day 0: Incomplete Neutralization
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
100 percentage of participants
Interval 95.1 to 100.0
|
100 percentage of participants
Interval 95.0 to 100.0
|
98.6 percentage of participants
Interval 92.7 to 100.0
|
|
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Day 14: Complete Neutralization
|
98.7 percentage of participants
Interval 96.2 to 99.7
|
100 percentage of participants
Interval 95.2 to 100.0
|
98.7 percentage of participants
Interval 92.8 to 100.0
|
98.7 percentage of participants
Interval 93.0 to 100.0
|
|
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Day 14: Incomplete Neutralization
|
1.3 percentage of participants
Interval 0.3 to 3.8
|
0 percentage of participants
Interval 0.0 to 4.8
|
1.3 percentage of participants
Interval 0.0 to 7.2
|
1.3 percentage of participants
Interval 0.0 to 7.0
|
|
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Day 28: Complete Neutralization
|
100 percentage of participants
Interval 98.5 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
|
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Day 28: Incomplete Neutralization
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 4.7
|
1.3 percentage of participants
Interval 0.0 to 6.9
|
0 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Day 42: Complete Neutralization
|
100 percentage of participants
Interval 98.4 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
100 percentage of participants
Interval 95.4 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
|
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Day 42: Incomplete Neutralization
|
0 percentage of participants
Interval 0.0 to 1.6
|
0 percentage of participants
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.6
|
0 percentage of participants
Interval 0.0 to 4.7
|
SECONDARY outcome
Timeframe: Within 30 minutes after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)Population: Analysis was performed on the safety analysis set (SafAS) that included participant who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received. Here, 'number analyzed' signifies participants with available data for each specified category.
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=320 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=107 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=107 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=104 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post-any vaccination
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post-vaccination 1
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post-vaccination 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post-vaccination 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)Population: Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category.
A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain, erythema and swelling at and around the injection site.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=320 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=107 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=107 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=104 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions
Pain Post-vaccination 3
|
73 Participants
|
14 Participants
|
23 Participants
|
23 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Pain Post-any vaccination
|
142 Participants
|
37 Participants
|
49 Participants
|
44 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Pain Post-vaccination 1
|
71 Participants
|
19 Participants
|
25 Participants
|
23 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Pain Post-vaccination 2
|
84 Participants
|
17 Participants
|
17 Participants
|
20 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Pain Post-vaccination 4
|
69 Participants
|
12 Participants
|
29 Participants
|
27 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Pain Post-vaccination 5
|
40 Participants
|
12 Participants
|
24 Participants
|
21 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema Post-any vaccination
|
5 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema Post-vaccination 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema Post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema Post-vaccination 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema Post-vaccination 4
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema Post-vaccination 5
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling Post-any vaccination
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling Post-vaccination 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling Post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling Post-vaccination 3
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling Post-vaccination 4
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling Post-vaccination 5
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)Population: Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category.
SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, headache, malaise and myalgia.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=320 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=107 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=107 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=104 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions
Fever Post-any vaccination
|
4 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever Post-vaccination 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever Post-vaccination 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever Post-vaccination 3
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever Post-vaccination 4
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever Post-vaccination 5
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache Post-any vaccination
|
107 Participants
|
35 Participants
|
38 Participants
|
36 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache Post-vaccination 1
|
44 Participants
|
20 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache Post-vaccination 2
|
26 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache Post-vaccination 3
|
38 Participants
|
13 Participants
|
16 Participants
|
14 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache Post-vaccination 4
|
29 Participants
|
10 Participants
|
5 Participants
|
14 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache Post-vaccination 5
|
23 Participants
|
7 Participants
|
5 Participants
|
13 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise Post-any vaccination
|
34 Participants
|
13 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise Post-vaccination 1
|
20 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise Post-vaccination 2
|
7 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise Post-vaccination 3
|
9 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise Post-vaccination 4
|
8 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise Post-vaccination 5
|
6 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia Post-any vaccination
|
118 Participants
|
37 Participants
|
38 Participants
|
33 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia Post-vaccination 1
|
58 Participants
|
17 Participants
|
23 Participants
|
20 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia Post-vaccination 2
|
50 Participants
|
11 Participants
|
9 Participants
|
14 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia Post-vaccination 3
|
50 Participants
|
13 Participants
|
15 Participants
|
12 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia Post-vaccination 4
|
35 Participants
|
8 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia Post-vaccination 5
|
26 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)Population: Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category.
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset post-vaccination.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=320 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=107 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=107 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=104 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
Post-vaccination 4
|
37 Participants
|
9 Participants
|
14 Participants
|
11 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Post-any vaccination
|
145 Participants
|
46 Participants
|
39 Participants
|
42 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Post-vaccination 1
|
47 Participants
|
22 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Post-vaccination 2
|
27 Participants
|
5 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Post-vaccination 3
|
31 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Post-vaccination 5
|
60 Participants
|
11 Participants
|
12 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)Population: Analysis was performed on the SafAS.
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.
Outcome measures
| Measure |
Group 1 VRVg-2+HRIG
n=320 Participants
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=107 Participants
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=107 Participants
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=104 Participants
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
AESI related to study vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
SAE
|
4 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
SAE related to study vaccine
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1 VRVg-2+HRIG
Serious events: 4 serious events
Other events: 204 other events
Deaths: 0 deaths
Group 2 Verorab+HRIG
Serious events: 4 serious events
Other events: 59 other events
Deaths: 0 deaths
Group 3 Imovax Rabies+HRIG
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Group 4 VRVg-2
Serious events: 3 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 VRVg-2+HRIG
n=320 participants at risk
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=107 participants at risk
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=107 participants at risk
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=104 participants at risk
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/320 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.93%
1/107 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/320 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.93%
1/107 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.31%
1/320 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma Benign
|
0.00%
0/320 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.96%
1/104 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Nervous system disorders
Cervical Radiculopathy
|
0.31%
1/320 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/320 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.93%
1/107 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/320 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.96%
1/104 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/320 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.93%
1/107 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/320 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.93%
1/107 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Psychiatric disorders
Eating Disorder
|
0.31%
1/320 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/320 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.96%
1/104 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.31%
1/320 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/107 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/104 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
Other adverse events
| Measure |
Group 1 VRVg-2+HRIG
n=320 participants at risk
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0.
|
Group 2 Verorab+HRIG
n=107 participants at risk
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 3 Imovax Rabies+HRIG
n=107 participants at risk
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
|
Group 4 VRVg-2
n=104 participants at risk
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
0.94%
3/320 • Number of events 3 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
5.6%
6/107 • Number of events 6 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.93%
1/107 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
0.96%
1/104 • Number of events 1 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
General disorders
Injection Site Pain
|
44.4%
142/320 • Number of events 337 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
34.6%
37/107 • Number of events 74 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
45.8%
49/107 • Number of events 118 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
42.3%
44/104 • Number of events 115 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
General disorders
Malaise
|
10.6%
34/320 • Number of events 50 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
12.1%
13/107 • Number of events 15 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
13.1%
14/107 • Number of events 17 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
12.5%
13/104 • Number of events 19 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.9%
118/320 • Number of events 221 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
34.6%
37/107 • Number of events 58 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
35.5%
38/107 • Number of events 71 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
32.7%
34/104 • Number of events 75 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
35.3%
113/320 • Number of events 173 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
32.7%
35/107 • Number of events 62 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
38.3%
41/107 • Number of events 59 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
38.5%
40/104 • Number of events 73 • Unsolicited AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected from Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Analysis was performed on SafAS. SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER