Trial Outcomes & Findings for Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age (NCT NCT02177032)
NCT ID: NCT02177032
Last Updated: 2017-04-07
Results Overview
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
885 participants
Primary outcome timeframe
Study day 50 (D50)
Results posted on
2017-04-07
Participant Flow
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
4-sites, 1-week WITHOUT HRIG
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
|
4-sites, 1-week WITH HRIG
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
355
|
88
|
354
|
88
|
|
Overall Study
COMPLETED
|
350
|
86
|
351
|
88
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
3
|
0
|
Reasons for withdrawal
| Measure |
4-sites, 1-week WITHOUT HRIG
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
|
4-sites, 1-week WITH HRIG
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Overall Study
ADMINISTRATIVE REASON
|
2
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
|
Overall Study
OTHER
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age
Baseline characteristics by cohort
| Measure |
4-sites, 1-week WITHOUT HRIG
n=355 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
|
4-sites, 1-week WITH HRIG
n=88 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
|
2-sites, TRC WITHOUT HRIG
n=354 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
n=88 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
Total
n=885 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
20.0 year
STANDARD_DEVIATION 15.0 • n=5 Participants
|
32.7 year
STANDARD_DEVIATION 10.8 • n=7 Participants
|
20.6 year
STANDARD_DEVIATION 15.1 • n=5 Participants
|
34.4 year
STANDARD_DEVIATION 11.2 • n=4 Participants
|
22.9 year
STANDARD_DEVIATION 15.3 • n=21 Participants
|
|
Sex: Female, Male
FEMALE
|
202 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
476 Participants
n=21 Participants
|
|
Sex: Female, Male
MALE
|
153 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
409 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Study day 50 (D50)Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=357 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=350 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)
|
99 Percentages of Subjects
Interval 98.0 to 100.0
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Day 50Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis
Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=357 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=350 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs
|
4.58 IU/mL
Interval 4.15 to 5.06
|
10 IU/mL
Interval 9.29 to 11.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 8, 15, 91, 181 and 366Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.
Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=363 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=362 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age
Day 8 (N= 363, 362)
|
0.23 IU/mL
Interval 0.21 to 0.25
|
0.14 IU/mL
Interval 0.13 to 0.15
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age
Day 15 (N= 357, 361)
|
18 IU/mL
Interval 17.0 to 20.0
|
12 IU/mL
Interval 10.0 to 13.0
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age
Day 91 (N= 358, 362)
|
2.32 IU/mL
Interval 2.09 to 2.56
|
3.68 IU/mL
Interval 3.32 to 4.07
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age
Day 181 (N= 357, 360)
|
1.59 IU/mL
Interval 1.41 to 1.78
|
1.44 IU/mL
Interval 1.28 to 1.62
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age
Day 366 (N= 356, 352)
|
1.59 IU/mL
Interval 1.41 to 1.79
|
1.14 IU/mL
Interval 1.01 to 1.28
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 8, 15, 91, 181 and 366Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population.
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=363 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=362 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age
Day 8 (N= 363, 362)
|
18 Percentages of Subjects
Interval 15.0 to 23.0
|
10 Percentages of Subjects
Interval 7.0 to 13.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age
Day 15 (N= 357, 361)
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age
Day 91 (N= 358, 362)
|
96 Percentages of Subjects
Interval 94.0 to 98.0
|
99 Percentages of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age
Day 181 (N= 357, 360)
|
93 Percentages of Subjects
Interval 90.0 to 95.0
|
93 Percentages of Subjects
Interval 90.0 to 96.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age
Day 366 (N= 356, 352)
|
90 Percentages of Subjects
Interval 86.0 to 93.0
|
83 Percentages of Subjects
Interval 79.0 to 87.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 8, 15, 50, 91, 181 and 366Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.
Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=66 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=150 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 15 (N= 65, 146)
|
13 IU/mL
Interval 11.0 to 15.0
|
15 IU/mL
Interval 13.0 to 17.0
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 50 (N= 65, 146)
|
1.97 IU/mL
Interval 1.6 to 2.43
|
4.47 IU/mL
Interval 3.9 to 5.13
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 8 (N= 66, 150)
|
0.21 IU/mL
Interval 0.17 to 0.26
|
0.15 IU/mL
Interval 0.13 to 0.17
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 91 (N= 65, 149)
|
1.01 IU/mL
Interval 0.81 to 1.27
|
2.28 IU/mL
Interval 1.96 to 2.65
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 181 (N= 65, 146)
|
0.88 IU/mL
Interval 0.67 to 1.14
|
1.92 IU/mL
Interval 1.61 to 2.29
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 366 (N= 65, 145)
|
0.68 IU/mL
Interval 0.53 to 0.88
|
1.42 IU/mL
Interval 1.19 to 1.69
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 8, 15,50, 91, 181 and 366Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.
Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=66 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=151 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 8 (N= 66, 150)
|
8 Percentages of Subjects
Interval 3.0 to 17.0
|
19 Percentages of Subjects
Interval 13.0 to 26.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 50 (N= 65, 146)
|
95 Percentages of Subjects
Interval 87.0 to 99.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 366 (N= 65, 145)
|
66 Percentages of Subjects
Interval 53.0 to 77.0
|
91 Percentages of Subjects
Interval 85.0 to 95.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 1 (N= 66, 151)
|
0 Percentages of Subjects
Interval 0.0 to 5.0
|
0 Percentages of Subjects
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 15 (N= 65, 146)
|
100 Percentages of Subjects
Interval 94.0 to 100.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 91 (N= 65, 149)
|
83 Percentages of Subjects
Interval 72.0 to 91.0
|
98 Percentages of Subjects
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 181 (N= 65, 146)
|
77 Percentages of Subjects
Interval 65.0 to 86.0
|
94 Percentages of Subjects
Interval 89.0 to 97.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 8, 15, 50, 91, 181 and 366Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.
Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=298 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=290 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
Day 1 (N=298, 290)
|
0.05 IU/mL
Interval 0.05 to 0.05
|
0.05 IU/mL
Interval 0.05 to 0.05
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
Day 8 (N= 297, 290)
|
0.23 IU/mL
Interval 0.21 to 0.25
|
0.13 IU/mL
Interval 0.12 to 0.14
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
Day 15 (N= 292, 289)
|
19 IU/mL
Interval 17.0 to 21.0
|
12 IU/mL
Interval 11.0 to 13.0
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
Day 366 (N= 291, 283)
|
1.73 IU/mL
Interval 1.53 to 1.95
|
1.2 IU/mL
Interval 1.06 to 1.36
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
Day 50 (N= 292, 281)
|
5.04 IU/mL
Interval 4.56 to 5.57
|
10 IU/mL
Interval 9.48 to 12.0
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
Day 91 (N= 293, 290)
|
2.54 IU/mL
Interval 2.29 to 2.82
|
3.8 IU/mL
Interval 3.42 to 4.21
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
Day 181 (N= 292, 289)
|
1.73 IU/mL
Interval 1.53 to 1.95
|
1.5 IU/mL
Interval 1.32 to 1.69
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 8, 15, 50, 91, 181 and 366Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is only applicable for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.
Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=298 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=290 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age
Day 8 (N= 297, 290)
|
21 Percentages of Subjects
Interval 16.0 to 26.0
|
10 Percentages of Subjects
Interval 7.0 to 14.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age
Day 15 (N= 292, 289)
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age
Day 50 (N= 292, 281)
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age
Day 91 (N= 293, 290)
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age
Day 181 (N= 292, 289)
|
96 Percentages of Subjects
Interval 93.0 to 98.0
|
96 Percentages of Subjects
Interval 92.0 to 98.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age
Day 366 (N= 291, 283)
|
95 Percentages of Subjects
Interval 92.0 to 97.0
|
87 Percentages of Subjects
Interval 82.0 to 90.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)Population: Solicited Safety Set- All subjects in the Exposed Population who provide post vaccination solicited adverse event data. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.
Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=356 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=85 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
n=353 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
n=89 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Headache (≥ 6 to ≤ 17 Y); Day 4
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Headache (≥ 6 to ≤ 17 Y); Day 8
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema(≥ 1 to ≤ 5 Y); Day 4
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema(≥ 1 to ≤ 5 Y); Day 8
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration(≥ 1 to ≤ 5 Y); Day 4
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration(≥ 1 to ≤ 5 Y); Day 8
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration(≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema (≥ 6 to ≤ 17 Y); Day 4
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Sleepiness (≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomiting (≥ 1 to ≤ 5 Y); Day 1
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomiting (≥ 1 to ≤ 5 Y); Day 4
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Irritability.( ≥ 1 to ≤ 5 Y); Day 1
|
5 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Irritability.( ≥ 1 to ≤ 5 Y); Day 4
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Irritability.( ≥ 1 to ≤ 5 Y); Day 8
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
5 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Irritability.( ≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
5 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Chills(≥ 6 to ≤ 17 Y); Day 1
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Nausea ( ≥ 6 to ≤ 17 Y); Day 8
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Nausea ( ≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 1
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 4
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Headache (≥ 6 to ≤ 17 Y); Day 1
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
9 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Rash (≥ 6 to ≤ 17 Y); Day 1
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Rash (≥ 6 to ≤ 17 Y); Day 4
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomitting (≥ 6 to ≤ 17 Y); Day 8
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 4
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Chills (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Nausea,( ≥ 18 Y); Day 1
|
8 Subjects
|
3 Subjects
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Nausea,( ≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Myalgia (≥ 18 Y); Day 4
|
16 Subjects
|
7 Subjects
|
12 Subjects
|
6 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Myalgia (≥ 18 Y); Day 8
|
20 Subjects
|
5 Subjects
|
15 Subjects
|
9 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Headache (≥ 18 Y); Day 8
|
19 Subjects
|
8 Subjects
|
15 Subjects
|
16 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Headache (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
12 Subjects
|
11 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Fatigue (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
9 Subjects
|
10 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Rash (≥ 18 Y); Day 1
|
10 Subjects
|
3 Subjects
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomitting (≥ 18 Y); Day 4
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomitting (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Loss Of Appetite (≥ 18 Y); Day 4
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Loss Of Appetite (≥ 18 Y); Day 8
|
3 Subjects
|
3 Subjects
|
2 Subjects
|
4 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site tenderness (≥ 1 to ≤ 5 Y); Day 4
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
9 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site pain (≥ 6 to ≤ 17 Y); Day 1
|
14 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
7 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site pain (≥ 6 to ≤ 17 Y); Day 4
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
10 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site pain (≥ 6 to ≤ 17 Y); Day 8
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
11 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site pain (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site pain (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
14 Subjects
|
9 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema(≥ 1 to ≤ 5 Y); Day 1
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema(≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration(≥ 1 to ≤ 5 Y); Day 1
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 1 to ≤ 5 Y); Day 1
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 1 to ≤ 5 Y); Day 4
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 1 to ≤ 5 Y); Day 8
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema (≥ 6 to ≤ 17 Y); Day 1
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema (≥ 6 to ≤ 17 Y); Day 8
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration (≥ 6 to ≤ 17 Y); Day 1
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration (≥ 6 to ≤ 17 Y); Day 4
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration (≥ 6 to ≤ 17 Y); Day 8
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 6 to ≤ 17 Y); Day 1
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 6 to ≤ 17 Y); Day 4
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 6 to ≤ 17 Y); Day 8
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema (≥ 18 Y); Day 1
|
3 Subjects
|
6 Subjects
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema (≥ 18 Y); Day 4
|
11 Subjects
|
4 Subjects
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema (≥ 18 Y); Day 8
|
12 Subjects
|
1 Subjects
|
8 Subjects
|
4 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site erythema (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
27 Subjects
|
13 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration (≥ 18 Y); Day 1
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration (≥ 18 Y); Day 4
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site induration (≥ 18 Y); Day 8
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 18 Y); Day 1
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 18 Y); Day 4
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 18 Y); Day 8
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site swelling (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
5 Subjects
|
1 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 1
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 4
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 8
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Sleepiness (≥ 1 to ≤ 5 Y); Day 1
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
7 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Sleepiness (≥ 1 to ≤ 5 Y); Day 4
|
7 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Sleepiness (≥ 1 to ≤ 5 Y); Day 8
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomiting (≥ 1 to ≤ 5 Y); Day 8
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomiting (≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
5 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 1 to ≤ 5 Y); Day 1
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 1 to ≤ 5 Y); Day 4
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 1 to ≤ 5 Y); Day 8
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Chills(≥ 6 to ≤ 17 Y); Day 4
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Chills(≥ 6 to ≤ 17 Y); Day 8
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Nausea ( ≥ 6 to ≤ 17 Y); Day 4
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Chills(≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Nausea ( ≥ 6 to ≤ 17 Y); Day 1
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 1
|
5 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 4
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 8
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 8
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Headache (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Fatigue (≥ 6 to ≤ 17 Y); Day 1
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
7 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Fatigue (≥ 6 to ≤ 17 Y); Day 4
|
5 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Fatigue (≥ 6 to ≤ 17 Y); Day 8
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Fatigue (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Rash (≥ 6 to ≤ 17 Y); Day 8
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Rash (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomitting (≥ 6 to ≤ 17 Y); Day 1
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
5 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomitting (≥ 6 to ≤ 17 Y); Day 4
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomitting (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 6 to ≤ 17 Y); Day 1
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
2 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 6 to ≤ 17 Y); Day 4
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 6 to ≤ 17 Y); Day 8
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 1
|
6 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 8
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Chills (≥ 18 Y); Day 1
|
8 Subjects
|
3 Subjects
|
5 Subjects
|
2 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Chills (≥ 18 Y); Day 4
|
1 Subjects
|
2 Subjects
|
6 Subjects
|
4 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Chills (≥ 18 Y); Day 8
|
5 Subjects
|
0 Subjects
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Nausea,( ≥ 18 Y); Day 4
|
4 Subjects
|
2 Subjects
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Nausea,( ≥ 18 Y); Day 8
|
4 Subjects
|
0 Subjects
|
4 Subjects
|
3 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Myalgia (≥ 18 Y); Day 1
|
23 Subjects
|
12 Subjects
|
19 Subjects
|
12 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Myalgia (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
7 Subjects
|
4 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Arthralgia (≥ 18 Y); Day 1
|
18 Subjects
|
7 Subjects
|
13 Subjects
|
7 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Arthralgia (≥ 18 Y); Day 4
|
6 Subjects
|
5 Subjects
|
10 Subjects
|
7 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Arthralgia (≥ 18 Y); Day 8
|
15 Subjects
|
3 Subjects
|
15 Subjects
|
6 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Generalized Arthralgia (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
6 Subjects
|
4 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Headache (≥ 18 Y); Day 1
|
24 Subjects
|
6 Subjects
|
11 Subjects
|
13 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Headache (≥ 18 Y); Day 4
|
14 Subjects
|
10 Subjects
|
15 Subjects
|
11 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Fatigue (≥ 18 Y); Day 1
|
28 Subjects
|
11 Subjects
|
19 Subjects
|
10 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Fatigue (≥ 18 Y); Day 4
|
21 Subjects
|
6 Subjects
|
17 Subjects
|
11 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Fatigue (≥ 18 Y); Day 8
|
19 Subjects
|
8 Subjects
|
15 Subjects
|
14 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Rash (≥ 18 Y); Day 4
|
4 Subjects
|
3 Subjects
|
8 Subjects
|
4 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Rash (≥ 18 Y); Day 8
|
6 Subjects
|
4 Subjects
|
11 Subjects
|
2 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Rash (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomitting (≥ 18 Y); Day 1
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Vomitting (≥ 18 Y); Day 8
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 18 Y); Day 1
|
5 Subjects
|
4 Subjects
|
2 Subjects
|
5 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 18 Y); Day 4
|
3 Subjects
|
2 Subjects
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 18 Y); Day 8
|
5 Subjects
|
1 Subjects
|
4 Subjects
|
4 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Diarrhea (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Loss Of Appetite (≥ 18 Y); Day 1
|
7 Subjects
|
0 Subjects
|
5 Subjects
|
2 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Loss Of Appetite (≥ 18 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
Not assessed at Day 29 for this group
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site tenderness (≥ 1 to ≤ 5 Y); Day 1
|
15 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site tenderness (≥ 1 to ≤ 5 Y); Day 8
|
7 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
8 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site tenderness (≥ 1 to ≤ 5 Y); Day 29
|
NA Subjects
Not assessed at Day 29 for this group
|
NA Subjects
No data as only adults to be enrolled to this group
|
9 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site pain (≥ 18 Y); Day 1
|
12 Subjects
|
6 Subjects
|
16 Subjects
|
11 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site pain (≥ 18 Y); Day 4
|
8 Subjects
|
8 Subjects
|
13 Subjects
|
3 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Injection site pain (≥ 18 Y); Day 8
|
8 Subjects
|
7 Subjects
|
21 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: Day 1 to Day 366Population: Unsolicited Safety Set- All subjects in the Exposed Population who have post vaccination unsolicited adverse event records. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.
Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=356 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=85 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
n=353 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
n=89 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 1 to ≤ 5 Y Any AEs;D1-366
|
45 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
53 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 6 to ≤ 17 Y Any AEs;D1-366
|
58 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
71 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 6 to ≤ 17 Y SAE;D1-366
|
1 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥6 to ≤ 17 Y At least possibly related SAEs;D1-366
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 6 to ≤ 17 Y Deaths;D1-366
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 18 Y Deaths;D1-366
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 18 Y Withdrawal from study due to AE;D1-366
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Overall population ≥ 1 Y Any AEs;D1-366
|
260 Subjects
|
71 Subjects
|
280 Subjects
|
73 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Overall population ≥ 1 Y SAE;D1-366
|
12 Subjects
|
3 Subjects
|
14 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Overall ≥1Y Atleast possibly related SAEs;D1-366
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Overall population ≥ 1 Y Deaths;D1-366
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 1 to ≤ 5 Y SAE;D1-366
|
3 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
4 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 1 to ≤ 5 Y At least possibly related SAEs;D1-366
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 1 to ≤ 5 Y Deaths;D1-366
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥1 to ≤ 5 Y Withdrawal from study due to AE;D1-366
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥6 to ≤17 Y Withdrawal from study due to AE;D1-366
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
0 Subjects
|
NA Subjects
No data as only adults to be enrolled to this group
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 18 Y Any AEs;D1-366
|
157 Subjects
|
71 Subjects
|
156 Subjects
|
72 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 18 Y SAE;D1-366
|
8 Subjects
|
3 Subjects
|
7 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
≥ 18 Y At least possibly related SAEs;D1-366
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Overall population ≥1Y Withdrawal due to AE;D1-366
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 8, 15, 50, 91, 181 and 366Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites TRC with HRIG Groups.
Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=66 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=72 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 1 (N= 66, 72)
|
0.05 IU/mL
Interval 0.05 to 0.05
|
0.05 IU/mL
Interval 0.05 to 0.05
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 15 (N= 65, 72)
|
13 IU/mL
Interval 11.0 to 15.0
|
8.37 IU/mL
Interval 6.96 to 10.0
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 8 (N= 66, 72)
|
0.21 IU/mL
Interval 0.17 to 0.26
|
0.17 IU/mL
Interval 0.14 to 0.21
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 50 (N= 65, 69)
|
1.97 IU/mL
Interval 1.6 to 2.43
|
6.37 IU/mL
Interval 5.21 to 7.78
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 91 (N= 65, 72)
|
1.01 IU/mL
Interval 0.81 to 1.27
|
2.25 IU/mL
Interval 1.81 to 2.79
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 181 (N= 65, 71)
|
0.88 IU/mL
Interval 0.67 to 1.14
|
1.05 IU/mL
Interval 0.81 to 1.35
|
—
|
—
|
|
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Day 366 (N= 65, 69)
|
0.68 IU/mL
Interval 0.53 to 0.88
|
0.59 IU/mL
Interval 0.46 to 0.76
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 8, 15,50, 91, 181 and 366Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites, TRC with HRIG Groups
Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age
Outcome measures
| Measure |
TOTAL 4-sites, 1-week
n=66 Participants
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
|
TOTAL 2-sites, TRC
n=72 Participants
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1
|
2-sites, TRC WITHOUT HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 15 (N= 65, 72)
|
100 Percentages of Subjects
Interval 94.0 to 100.0
|
99 Percentages of Subjects
Interval 93.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 91 (N= 65, 72)
|
83 Percentages of Subjects
Interval 72.0 to 91.0
|
99 Percentages of Subjects
Interval 93.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 1 (N= 66, 72)
|
0 Percentages of Subjects
Interval 0.0 to 5.0
|
0 Percentages of Subjects
Interval 0.0 to 5.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 8 (N= 66, 72)
|
8 Percentages of Subjects
Interval 3.0 to 17.0
|
10 Percentages of Subjects
Interval 4.0 to 19.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 50 (N= 65, 69)
|
95 Percentages of Subjects
Interval 87.0 to 99.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 181 (N= 65, 71)
|
77 Percentages of Subjects
Interval 65.0 to 86.0
|
85 Percentages of Subjects
Interval 74.0 to 92.0
|
—
|
—
|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Day 366 (N= 65, 69)
|
66 Percentages of Subjects
Interval 53.0 to 77.0
|
70 Percentages of Subjects
Interval 57.0 to 80.0
|
—
|
—
|
Adverse Events
4-sites, 1-week WITHOUT HRIG
Serious events: 5 serious events
Other events: 292 other events
Deaths: 0 deaths
4-sites, 1-week WITH HRIG
Serious events: 1 serious events
Other events: 78 other events
Deaths: 0 deaths
2-sites, TRC WITHOUT HRIG
Serious events: 4 serious events
Other events: 298 other events
Deaths: 0 deaths
2-sites, TRC WITH HRIG
Serious events: 2 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4-sites, 1-week WITHOUT HRIG
n=356 participants at risk
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
|
4-sites, 1-week WITH HRIG
n=85 participants at risk
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
|
2-sites, TRC WITHOUT HRIG
n=353 participants at risk
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
n=89 participants at risk
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.1%
1/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Gastrointestinal disorders
Gastritis
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
Pyrexia
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Appendiceal Abscess
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.2%
1/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Appendicitis Perforated
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Dengue Fever
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.2%
1/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
HIV Infection
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Hand-Foot-And-Mouth Disease
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Immune system disorders
Influenza
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.2%
1/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.1%
1/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
1.4%
5/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.1%
4/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
2.2%
2/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Injury, poisoning and procedural complications
Animal Scratch
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.57%
2/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.1%
1/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
0.28%
1/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.28%
1/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
0.00%
0/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
Other adverse events
| Measure |
4-sites, 1-week WITHOUT HRIG
n=356 participants at risk
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
|
4-sites, 1-week WITH HRIG
n=85 participants at risk
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
|
2-sites, TRC WITHOUT HRIG
n=353 participants at risk
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
|
2-sites, TRC WITH HRIG
n=89 participants at risk
8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
7.9%
28/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
9.4%
8/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
5.7%
20/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
9.0%
8/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Gastrointestinal disorders
NAUSEA
|
6.2%
22/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
4.7%
4/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
3.4%
12/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
7.9%
7/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Gastrointestinal disorders
VOMITING
|
4.2%
15/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.2%
1/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
5.7%
20/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
4.5%
4/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
CHILLS
|
4.2%
15/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
4.7%
4/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
3.7%
13/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
5.6%
5/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
FATIGUE
|
14.9%
53/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
18.8%
16/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
14.7%
52/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
27.0%
24/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
54.8%
195/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
69.4%
59/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
47.6%
168/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
62.9%
56/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
INJECTION SITE INDURATION
|
14.6%
52/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
15.3%
13/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
17.6%
62/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
14.6%
13/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
INJECTION SITE PAIN
|
21.6%
77/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
21.2%
18/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
25.2%
89/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
22.5%
20/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
INJECTION SITE SWELLING
|
11.0%
39/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
9.4%
8/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
13.3%
47/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
4.5%
4/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
PYREXIA
|
4.2%
15/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
3.5%
3/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
7.6%
27/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
4.5%
4/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
VACCINATION SITE ERYTHEMA
|
23.0%
82/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
22.4%
19/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
22.4%
79/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
25.8%
23/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
VACCINATION SITE INDURATION
|
7.3%
26/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
5.9%
5/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
6.2%
22/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
7.9%
7/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
General disorders
VACCINATION SITE SWELLING
|
3.7%
13/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
5.9%
5/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
5.4%
19/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
2.2%
2/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.7%
13/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
1.2%
1/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
7.9%
28/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
2.2%
2/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.3%
19/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
7.1%
6/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
7.9%
28/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
5.6%
5/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
5.3%
19/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
5.9%
5/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
3.4%
12/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
7.9%
7/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.3%
33/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
10.6%
9/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
9.3%
33/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
19.1%
17/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
12.6%
45/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
22.4%
19/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
11.6%
41/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
21.3%
19/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Nervous system disorders
HEADACHE
|
14.9%
53/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
24.7%
21/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
15.3%
54/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
34.8%
31/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.9%
21/356 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
8.2%
7/85 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
6.8%
24/353 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
6.7%
6/89 • Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER