Trial Outcomes & Findings for Immunogenicity and Safety of a Purified Vero Rabies Vaccine (NCT NCT03145766)
NCT ID: NCT03145766
Last Updated: 2022-04-19
Results Overview
RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
320 participants
Primary outcome timeframe
Day 0
Results posted on
2022-04-19
Participant Flow
The study was conducted at 5 centers in the United States from 17 April 2017 to 08 January 2018.
A total of 320 participants were enrolled and vaccinated in the study.
Participant milestones
| Measure |
Group 1: VRVg-2 Formulation 1
VRVg-2 formulation 1 (Low), intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0.
|
Group 2:VRVg-2 Formulation 2
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Active Vaccination Phase (Day 0-Day 56)
NOT COMPLETED
|
6
|
3
|
2
|
7
|
3
|
|
Follow-up Phase (Day 56 Till Month 7)
STARTED
|
74
|
77
|
78
|
33
|
37
|
|
Active Vaccination Phase (Day 0-Day 56)
STARTED
|
80
|
80
|
80
|
40
|
40
|
|
Active Vaccination Phase (Day 0-Day 56)
Vaccination 1
|
80
|
80
|
80
|
39
|
41
|
|
Active Vaccination Phase (Day 0-Day 56)
Vaccination 2
|
77
|
81
|
80
|
39
|
39
|
|
Active Vaccination Phase (Day 0-Day 56)
Vaccination 3
|
78
|
79
|
80
|
39
|
38
|
|
Active Vaccination Phase (Day 0-Day 56)
Vaccination 4
|
78
|
79
|
80
|
38
|
38
|
|
Active Vaccination Phase (Day 0-Day 56)
Vaccination 5
|
75
|
78
|
79
|
34
|
37
|
|
Active Vaccination Phase (Day 0-Day 56)
COMPLETED
|
74
|
77
|
78
|
33
|
37
|
|
Follow-up Phase (Day 56 Till Month 7)
COMPLETED
|
67
|
75
|
73
|
30
|
34
|
|
Follow-up Phase (Day 56 Till Month 7)
NOT COMPLETED
|
7
|
2
|
5
|
3
|
3
|
Reasons for withdrawal
| Measure |
Group 1: VRVg-2 Formulation 1
VRVg-2 formulation 1 (Low), intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0.
|
Group 2:VRVg-2 Formulation 2
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Active Vaccination Phase (Day 0-Day 56)
Other Adverse Event (AE)
|
1
|
1
|
0
|
1
|
2
|
|
Active Vaccination Phase (Day 0-Day 56)
Non-compliance with the Protocol
|
0
|
0
|
1
|
2
|
1
|
|
Active Vaccination Phase (Day 0-Day 56)
Lost to Follow-up
|
1
|
1
|
0
|
3
|
0
|
|
Active Vaccination Phase (Day 0-Day 56)
Voluntary Withdrawal Not Due AE
|
4
|
1
|
1
|
1
|
0
|
|
Follow-up Phase (Day 56 Till Month 7)
Non-compliance with the Protocol
|
2
|
0
|
0
|
1
|
0
|
|
Follow-up Phase (Day 56 Till Month 7)
Lost to Follow-up
|
4
|
1
|
4
|
2
|
3
|
|
Follow-up Phase (Day 56 Till Month 7)
Voluntary Withdrawal not due to AE
|
1
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety of a Purified Vero Rabies Vaccine
Baseline characteristics by cohort
| Measure |
Group 1: VRVg-2 Formulation 1
n=80 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=80 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=80 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=40 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=40 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 13.1 • n=21 Participants
|
41.4 years
STANDARD_DEVIATION 13.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
158 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
162 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
78 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
217 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Per-Protocol Analysis Set (PPAS): participants who received at least one dose of the study vaccine without protocol deviations before Day 14 (i.e., 7 days after the 3rd vaccine injection).
RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=72 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=75 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=71 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=35 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=34 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0
|
0.101 international units per milliliter
Interval 0.099 to 0.102
|
0.100 international units per milliliter
Upper and lower limit of 95% confidence interval (CI) was not estimable because all the participants had same value and no variability was observed.
|
0.102 international units per milliliter
Interval 0.099 to 0.104
|
0.101 international units per milliliter
Interval 0.099 to 0.103
|
0.100 international units per milliliter
Upper and lower limit of 95% CI was not estimable because all the participants had same value and no variability was observed.
|
PRIMARY outcome
Timeframe: Day 14Population: Analysis was performed on PPAS.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=72 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=75 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=71 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=35 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=34 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14
|
1.28 international units per milliliter
Interval 0.944 to 1.73
|
1.79 international units per milliliter
Interval 1.33 to 2.41
|
2.52 international units per milliliter
Interval 1.93 to 3.28
|
1.38 international units per milliliter
Interval 0.936 to 2.05
|
1.56 international units per milliliter
Interval 1.06 to 2.29
|
PRIMARY outcome
Timeframe: Day 28Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=66 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=73 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=68 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=29 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=33 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28
|
3.22 international units per milliliter
Interval 2.48 to 4.17
|
4.64 international units per milliliter
Interval 3.53 to 6.1
|
6.81 international units per milliliter
Interval 5.52 to 8.39
|
3.04 international units per milliliter
Interval 1.86 to 4.95
|
4.86 international units per milliliter
Interval 3.56 to 6.65
|
PRIMARY outcome
Timeframe: Day 42Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=69 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=72 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=65 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=30 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=31 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42
|
8.14 international units per milliliter
Interval 6.6 to 10.0
|
9.68 international units per milliliter
Interval 7.5 to 12.5
|
15.6 international units per milliliter
Interval 12.7 to 19.1
|
6.98 international units per milliliter
Interval 4.69 to 10.4
|
8.99 international units per milliliter
Interval 6.48 to 12.5
|
PRIMARY outcome
Timeframe: Month 7Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=61 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=71 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=64 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=27 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=31 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7
|
0.894 international units per milliliter
Interval 0.667 to 1.2
|
0.971 international units per milliliter
Interval 0.768 to 1.23
|
1.58 international units per milliliter
Interval 1.28 to 1.94
|
0.939 international units per milliliter
Interval 0.634 to 1.39
|
1.01 international units per milliliter
Interval 0.649 to 1.58
|
PRIMARY outcome
Timeframe: Day 0Population: Analysis was performed on PPAS.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=72 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=75 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=71 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=35 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=34 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0
RVNA titer >= 0.2 IU/mL
|
0 percentage of participants
Interval 0.0 to 5.0
|
0 percentage of participants
Interval 0.0 to 4.8
|
0 percentage of participants
Interval 0.0 to 5.1
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 10.3
|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0
RVNA titer >= 0.5 IU/mL
|
0 percentage of participants
Interval 0.0 to 5.0
|
0 percentage of participants
Interval 0.0 to 4.8
|
0 percentage of participants
Interval 0.0 to 5.1
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 10.3
|
PRIMARY outcome
Timeframe: Day 14Population: Analysis was performed on PPAS.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=72 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=75 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=71 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=35 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=34 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14
RVNA titer >= 0.2 IU/mL
|
93.1 percentage of participants
Interval 84.5 to 97.7
|
96.0 percentage of participants
Interval 88.8 to 99.2
|
97.2 percentage of participants
Interval 90.2 to 99.7
|
97.1 percentage of participants
Interval 85.1 to 99.9
|
97.1 percentage of participants
Interval 84.7 to 99.9
|
|
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14
RVNA titer >= 0.5 IU/mL
|
75.0 percentage of participants
Interval 63.4 to 84.5
|
81.3 percentage of participants
Interval 70.7 to 89.4
|
90.1 percentage of participants
Interval 80.7 to 95.9
|
80.0 percentage of participants
Interval 63.1 to 91.6
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
PRIMARY outcome
Timeframe: Day 28Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=66 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=73 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=68 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=29 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=33 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28
RVNA titers >= 0.2 IU/mL
|
98.5 percentage of participants
Interval 91.8 to 100.0
|
98.6 percentage of participants
Interval 92.6 to 100.0
|
100 percentage of participants
Interval 94.7 to 100.0
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
100 percentage of participants
Interval 89.4 to 100.0
|
|
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28
RVNA titers >= 0.5 IU/mL
|
93.9 percentage of participants
Interval 85.2 to 98.3
|
95.9 percentage of participants
Interval 88.5 to 99.1
|
100 percentage of participants
Interval 94.7 to 100.0
|
86.2 percentage of participants
Interval 68.3 to 96.1
|
100 percentage of participants
Interval 89.4 to 100.0
|
PRIMARY outcome
Timeframe: Day 42Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=69 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=72 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=65 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=30 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=31 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42
RVNA titers >= 0.2 IU/mL
|
100 percentage of participants
Interval 94.8 to 100.0
|
98.6 percentage of participants
Interval 92.5 to 100.0
|
100 percentage of participants
Interval 94.5 to 100.0
|
96.7 percentage of participants
Interval 82.8 to 99.9
|
100 percentage of participants
Interval 88.8 to 100.0
|
|
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42
RVNA titers >= 0.5 IU/mL
|
100 percentage of participants
Interval 94.8 to 100.0
|
98.6 percentage of participants
Interval 92.5 to 100.0
|
100 percentage of participants
Interval 94.5 to 100.0
|
96.7 percentage of participants
Interval 82.8 to 99.9
|
100 percentage of participants
Interval 88.8 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>= 0.2 IU/mL were considered as seropositive.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=61 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=71 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=64 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=27 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=31 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7
RVNA titers >= 0.2 IU/mL
|
93.4 percentage of participants
Interval 84.1 to 98.2
|
93.0 percentage of participants
Interval 84.3 to 97.7
|
100 percentage of participants
Interval 94.4 to 100.0
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
87.1 percentage of participants
Interval 70.2 to 96.4
|
|
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7
RVNA titers >= 0.5 IU/mL
|
70.5 percentage of participants
Interval 57.4 to 81.5
|
77.5 percentage of participants
Interval 66.0 to 86.5
|
92.2 percentage of participants
Interval 82.7 to 97.4
|
74.1 percentage of participants
Interval 53.7 to 88.9
|
74.2 percentage of participants
Interval 55.4 to 88.1
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose) and Day 14 (7 days post-dose 3)Population: Analysis was performed on PPAS.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 7 days post 3rd vaccination (i.e., on Day 14) and pre-vaccination on Day 0.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=72 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=75 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=71 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=35 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=34 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0)
|
12.7 ratio
Interval 9.37 to 17.1
|
17.9 ratio
Interval 13.3 to 24.1
|
24.8 ratio
Interval 19.0 to 32.3
|
13.7 ratio
Interval 9.27 to 20.3
|
15.6 ratio
Interval 10.6 to 22.9
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose) and Day 28 (14 days post-dose 4)Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 4th vaccination (i.e., on Day 28) and pre-vaccination on Day 0.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=66 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=73 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=68 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=29 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=33 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0)
|
31.9 ratio
Interval 24.6 to 41.3
|
46.4 ratio
Interval 35.3 to 61.0
|
67.0 ratio
Interval 54.4 to 82.6
|
30.0 ratio
Interval 18.5 to 48.7
|
48.6 ratio
Interval 35.6 to 66.5
|
PRIMARY outcome
Timeframe: Day 0 (Pre-dose) and Day 42 (14 days Post-dose 5)Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 5th vaccination (i.e., on Day 42) and pre-vaccination on Day 0.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=69 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=72 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=65 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=30 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=31 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0)
|
80.7 ratio
Interval 65.6 to 99.3
|
96.8 ratio
Interval 75.0 to 125.0
|
153 ratio
Interval 125.0 to 188.0
|
69.0 ratio
Interval 46.4 to 103.0
|
89.9 ratio
Interval 64.8 to 125.0
|
PRIMARY outcome
Timeframe: Day 0 (Pre-dose) and Month 7 (6 Months Post Last Vaccination)Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 6 month post last vaccination on Month 7 and pre-vaccination on Day 0.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=61 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=71 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=64 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=27 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=31 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0)
|
8.86 ratio
Interval 6.66 to 11.8
|
9.71 ratio
Interval 7.68 to 12.3
|
15.5 ratio
Interval 12.6 to 19.0
|
9.27 ratio
Interval 6.26 to 13.7
|
10.1 ratio
Interval 6.49 to 15.8
|
PRIMARY outcome
Timeframe: Day 0Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=72 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=75 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=71 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=34 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=34 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0
|
0 percentage of participants
Interval 0.0 to 5.0
|
0 percentage of participants
Interval 0.0 to 4.8
|
0 percentage of participants
Interval 0.0 to 5.1
|
0 percentage of participants
Interval 0.0 to 10.3
|
0 percentage of participants
Interval 0.0 to 10.3
|
PRIMARY outcome
Timeframe: Day 14Population: Analysis was performed on PPAS.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=72 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=75 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=71 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=35 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=34 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14
|
79.2 percentage of participants
Interval 68.0 to 87.8
|
89.3 percentage of participants
Interval 80.1 to 95.3
|
93.0 percentage of participants
Interval 84.3 to 97.7
|
82.9 percentage of participants
Interval 66.4 to 93.4
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
PRIMARY outcome
Timeframe: Day 28Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=69 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=74 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=70 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=32 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=33 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28
|
92.8 percentage of participants
Interval 83.9 to 97.6
|
94.6 percentage of participants
Interval 86.7 to 98.5
|
98.6 percentage of participants
Interval 92.3 to 100.0
|
100 percentage of participants
Interval 89.1 to 100.0
|
93.9 percentage of participants
Interval 79.8 to 99.3
|
PRIMARY outcome
Timeframe: Day 42Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=69 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=74 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=68 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=31 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=33 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42
|
97.1 percentage of participants
Interval 89.9 to 99.6
|
93.2 percentage of participants
Interval 84.9 to 97.8
|
94.1 percentage of participants
Interval 85.6 to 98.4
|
100 percentage of participants
Interval 88.8 to 100.0
|
93.9 percentage of participants
Interval 79.8 to 99.3
|
PRIMARY outcome
Timeframe: Month 7Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=61 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=71 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=65 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=27 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=31 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7
|
95.1 percentage of participants
Interval 86.3 to 99.0
|
88.7 percentage of participants
Interval 79.0 to 95.0
|
100 percentage of participants
Interval 94.5 to 100.0
|
85.2 percentage of participants
Interval 66.3 to 95.8
|
93.5 percentage of participants
Interval 78.6 to 99.2
|
PRIMARY outcome
Timeframe: Within 30 Minutes After any VaccinationPopulation: Analysis was performed on safety analysis set (SafAS) that included participant who had received at least one least one dose of the study vaccine and were analyzed according to the actual treatment received. 1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis.
An adverse event was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have 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 form (CRF) 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 CRF. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=80 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=80 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=80 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=39 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=41 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Number of Participants With Immediate Unsolicited Adverse Events
Immediate Unsolicited AR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Immediate Unsolicited Adverse Events
Immediate Unsolicited AE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5)Population: Analysis performed on SafAS. Here, 'number analyzed' = participants with available data for each specified category.1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. At Vaccination 2, 1 participant of Group 1 received Group 2 vaccine and thus counted in Group 2 for post-vaccination 2 safety analysis.
A solicited reaction (SR) was an AR observed and reported under conditions (symptoms and onset) prelisted (i.e., solicited) in the CRF 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 Formulation 1
n=80 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=81 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=80 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=39 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=41 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Pain Post-vaccination 1
|
13 Participants
|
20 Participants
|
26 Participants
|
10 Participants
|
16 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Pain Post-vaccination 3
|
14 Participants
|
10 Participants
|
20 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Erythema Post-vaccination 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Swelling post-any vaccination
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Swelling Post-vaccination 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Swelling Post-vaccination 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Pain post-any vaccination
|
29 Participants
|
32 Participants
|
38 Participants
|
14 Participants
|
24 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Pain Post-vaccination 2
|
12 Participants
|
12 Participants
|
18 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Pain Post-vaccination 4
|
16 Participants
|
11 Participants
|
17 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Pain Post-vaccination 5
|
14 Participants
|
7 Participants
|
14 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Erythema post-any vaccination
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Erythema Post-vaccination 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Erythema Post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Erythema Post-vaccination 4
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Erythema Post-vaccination 5
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Swelling Post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Swelling Post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Injection Site Reactions
Swelling Post-vaccination 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5)Population: Analysis performed on SafAS. Here, 'number analyzed' = participants with available data for each specified category.1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. At Vaccination 2, 1 participant of Group 1 received Group 2 vaccine and thus counted in Group 2 for post-vaccination 2 safety analysis.
A solicited reaction was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF 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 Formulation 1
n=80 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=81 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=80 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=39 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=41 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Solicited Systemic Reactions
Headache Post-any Vaccination
|
26 Participants
|
12 Participants
|
20 Participants
|
9 Participants
|
15 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Fever Post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Fever Post-vaccination 3
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Fever Post-any Vaccination
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Fever Post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Headache Post-vaccination 3
|
14 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
10 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Headache Post-vaccination 5
|
7 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Malaise Post-vaccination 1
|
14 Participants
|
8 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Malaise Post-vaccination 3
|
8 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Malaise Post-vaccination 4
|
6 Participants
|
4 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Myalgia Post-any Vaccination
|
25 Participants
|
22 Participants
|
20 Participants
|
11 Participants
|
19 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Fever Post-vaccination 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Fever Post-vaccination 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Headache Post-vaccination 1
|
11 Participants
|
8 Participants
|
15 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Headache Post-vaccination 2
|
11 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Headache Post-vaccination 4
|
6 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Malaise Post-any Vaccination
|
26 Participants
|
13 Participants
|
17 Participants
|
11 Participants
|
16 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Malaise Post-vaccination 2
|
8 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
10 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Malaise Post-vaccination 5
|
5 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Myalgia Post-vaccination 1
|
16 Participants
|
14 Participants
|
15 Participants
|
5 Participants
|
13 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Myalgia Post-vaccination 2
|
9 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Myalgia Post-vaccination 3
|
8 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Myalgia Post-vaccination 4
|
9 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With at Least One Solicited Systemic Reactions
Myalgia Post-vaccination 5
|
7 Participants
|
5 Participants
|
10 Participants
|
3 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Within 28 Days After any vaccinationPopulation: Analysis was performed on SafAS. 1 participant of Group 4 received Imovax Rabies vaccine, and thus counted in Group 5 for safety analysis.
An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=80 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=80 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=80 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=39 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=41 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Unsolicited Adverse Events
|
11 Participants
|
11 Participants
|
20 Participants
|
10 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 7Population: Analysis was performed on SafAS. 1 participant of Group 4 received Imovax Rabies vaccine, and thus counted in Group 5 for safety analysis.
An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have 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.
Outcome measures
| Measure |
Group 1: VRVg-2 Formulation 1
n=80 Participants
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2:VRVg-2 Formulation 2
n=80 Participants
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=80 Participants
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=39 Participants
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=41 Participants
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: VRVg-2 Formulation 1
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Group 2: VRVg-2 Formulation 2
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Group 3: VRVg-2 Formulation 3
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Group 4: VRVg-1
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Group 5: Imovax Rabies
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: VRVg-2 Formulation 1
n=80 participants at risk
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2: VRVg-2 Formulation 2
n=80 participants at risk
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=80 participants at risk
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=39 participants at risk
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=41 participants at risk
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/80 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/80 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
1.2%
1/80 • Number of events 1 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/39 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
0.00%
0/41 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
Other adverse events
| Measure |
Group 1: VRVg-2 Formulation 1
n=80 participants at risk
VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 2: VRVg-2 Formulation 2
n=80 participants at risk
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 3: VRVg-2 Formulation 3
n=80 participants at risk
VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 4: VRVg-1
n=39 participants at risk
VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
Group 5: Imovax Rabies
n=41 participants at risk
Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
|
|---|---|---|---|---|---|
|
General disorders
Application Site Bruise
|
0.00%
0/80 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
1.2%
1/80 • Number of events 1 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
1.2%
1/80 • Number of events 1 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
5.1%
2/39 • Number of events 2 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
2.4%
1/41 • Number of events 1 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
|
General disorders
Injection Site Pain
|
36.2%
29/80 • Number of events 69 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
40.0%
32/80 • Number of events 60 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
47.5%
38/80 • Number of events 95 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
35.9%
14/39 • Number of events 30 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
58.5%
24/41 • Number of events 56 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
|
General disorders
Malaise
|
32.5%
26/80 • Number of events 41 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
16.2%
13/80 • Number of events 20 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
21.2%
17/80 • Number of events 35 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
28.2%
11/39 • Number of events 21 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
39.0%
16/41 • Number of events 35 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.2%
25/80 • Number of events 49 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
27.5%
22/80 • Number of events 36 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
25.0%
20/80 • Number of events 41 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
28.2%
11/39 • Number of events 21 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
46.3%
19/41 • Number of events 44 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
32.5%
26/80 • Number of events 49 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
15.0%
12/80 • Number of events 20 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
26.2%
21/80 • Number of events 42 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
25.6%
10/39 • Number of events 13 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
|
36.6%
15/41 • Number of events 41 • 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 throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF 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