Trial Outcomes & Findings for A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults (NCT NCT01680016)
NCT ID: NCT01680016
Last Updated: 2014-05-20
Results Overview
Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
644 participants
Primary outcome timeframe
Before vaccination (day 1) and 14 days after first vaccination (day 15)
Results posted on
2014-05-20
Participant Flow
Subjects were enrolled at Mengshan CDC
All enrolled subjects were included in the trial
Participant milestones
| Measure |
Zagreb(≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥51 Years)
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥51 Years)
≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
121
|
122
|
201
|
200
|
|
Overall Study
COMPLETED
|
115
|
114
|
196
|
195
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
5
|
5
|
Reasons for withdrawal
| Measure |
Zagreb(≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥51 Years)
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥51 Years)
≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
4
|
|
Overall Study
The Subject went out of The Trial
|
1
|
0
|
3
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
1
|
1
|
Baseline Characteristics
A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
Baseline characteristics by cohort
| Measure |
Zagreb
n=322 Participants
Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen
n=322 Participants
Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Total
n=644 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Children (≥6 to ≤17 Years)
|
11 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
10.9 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Age, Continuous
Older Adults (≥51 Years)
|
62.1 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex/Gender, Customized
Female (≥6 to ≤17 Years)
|
49 Subjects
n=5 Participants
|
76 Subjects
n=7 Participants
|
125 Subjects
n=5 Participants
|
|
Sex/Gender, Customized
Male (≥6 to ≤17 Years)
|
72 Subjects
n=5 Participants
|
46 Subjects
n=7 Participants
|
118 Subjects
n=5 Participants
|
|
Sex/Gender, Customized
Female (≥51 Years)
|
118 Subjects
n=5 Participants
|
123 Subjects
n=7 Participants
|
241 Subjects
n=5 Participants
|
|
Sex/Gender, Customized
Male (≥51 Years)
|
83 Subjects
n=5 Participants
|
77 Subjects
n=7 Participants
|
160 Subjects
n=5 Participants
|
PRIMARY outcome
Timeframe: Before vaccination (day 1) and 14 days after first vaccination (day 15)Population: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.
Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=114 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=110 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.
Day 1
|
0.052 IU/mL
Interval 0.048 to 0.056
|
0.054 IU/mL
Interval 0.05 to 0.058
|
—
|
—
|
—
|
—
|
|
Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.
Day 15
|
12 IU/mL
Interval 10.0 to 14.0
|
14 IU/mL
Interval 12.0 to 16.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before vaccination (day 1) and 14 days after first vaccination (day 15).Population: Analysis was done on the PP set.
Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=190 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=188 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years
Day 1
|
0.057 IU/mL
Interval 0.052 to 0.063
|
0.06 IU/mL
Interval 0.055 to 0.066
|
—
|
—
|
—
|
—
|
|
Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years
Day 15
|
8.57 IU/mL
Interval 7.34 to 10.0
|
7.89 IU/mL
Interval 6.75 to 9.21
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 7 postvaccinationPopulation: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=60 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=59 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
n=61 Participants
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
n=60 Participants
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
n=121 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=119 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Injection Site Erythema(N=59,58,60,60,119,118)
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Injection Site Induration(N=59,58,60,60,119,118)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Injection Site Pain(N=59,58,60,60,119,118)
|
21 Subjects
|
18 Subjects
|
24 Subjects
|
29 Subjects
|
45 Subjects
|
47 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Nausea(N=59,58,60,60,119,118)
|
2 Subjects
|
4 Subjects
|
5 Subjects
|
6 Subjects
|
7 Subjects
|
10 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Myalgia(N=59,58,60,60,119,118)
|
4 Subjects
|
4 Subjects
|
7 Subjects
|
9 Subjects
|
11 Subjects
|
13 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Arthralgia(N=59,58,60,60,119,118)
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Headache(N=59,58,60,60,119,118)
|
4 Subjects
|
4 Subjects
|
7 Subjects
|
6 Subjects
|
11 Subjects
|
10 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Fatigue(N=59,58,60,60,119,118)
|
8 Subjects
|
4 Subjects
|
10 Subjects
|
11 Subjects
|
18 Subjects
|
15 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Loss of Appetite(N=59,58,60,60,119,118)
|
7 Subjects
|
3 Subjects
|
7 Subjects
|
7 Subjects
|
14 Subjects
|
10 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Body Temp. (≥38°C)(N=59,58,60,60,119,118)
|
6 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
8 Subjects
|
3 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Low Grade Fever(N=59,58,60,60,119,118)
|
6 Subjects
|
7 Subjects
|
11 Subjects
|
11 Subjects
|
17 Subjects
|
18 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Medium Grade Fever(N=59,58,60,60,119,118)
|
9 Subjects
|
5 Subjects
|
4 Subjects
|
2 Subjects
|
13 Subjects
|
7 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
High Grade Fever(N=59,58,60,60,119,118)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Analge,Antipyr Used(N=59,58,60,60,119,118)
|
7 Subjects
|
4 Subjects
|
4 Subjects
|
4 Subjects
|
11 Subjects
|
8 Subjects
|
PRIMARY outcome
Timeframe: Days 1 to 7 postvaccinationPopulation: Analysis was done on the safety set
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=100 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=100 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
n=100 Participants
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
n=100 Participants
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
n=200 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=200 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Injection Site Erythema(N=98,100,99,100,197,200)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Injection Site Induration(N=98,100,99,100,197,200)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Injection Site Pain(N=98,100,99,100,197,200)
|
9 Subjects
|
12 Subjects
|
9 Subjects
|
10 Subjects
|
18 Subjects
|
22 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Nausea(N=98,100,99,100,197,200)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Myalgia(N=98,100,99,100,197,200)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Arthralgia(N=98,100,99,100,197,200)
|
0 Subjects
|
2 Subjects
|
3 Subjects
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Headache(N=98,100,99,100,197,200)
|
4 Subjects
|
2 Subjects
|
3 Subjects
|
6 Subjects
|
7 Subjects
|
8 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Fatigue(N=98,100,99,100,197,200)
|
3 Subjects
|
4 Subjects
|
6 Subjects
|
3 Subjects
|
9 Subjects
|
7 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Loss of Appetite(N=98,100,99,100,197,200)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Body Temp.(≥38°C)(N=98,100,99,100,197,200)
|
0 Subjects
|
1 Subjects
|
5 Subjects
|
4 Subjects
|
5 Subjects
|
5 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Low Grade Fever(N=98,100,99,100,197,200)
|
3 Subjects
|
5 Subjects
|
3 Subjects
|
6 Subjects
|
6 Subjects
|
11 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Medium Grade Fever(N=98,100,99,100,197,200)
|
1 Subjects
|
2 Subjects
|
5 Subjects
|
6 Subjects
|
6 Subjects
|
8 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
High Grade Fever(N=98,100,99,100,197,200)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Analgesic,Antipyretic use(N=98,100,99,100,197,200)
|
6 Subjects
|
6 Subjects
|
7 Subjects
|
9 Subjects
|
13 Subjects
|
15 Subjects
|
PRIMARY outcome
Timeframe: From V1/day 1 (postvaccination) through V7/study termination day 43Population: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \[SAE\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=121 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=119 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Number of Children Who Reported Unsolicited Adverse Events (AEs)
Death
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Children Who Reported Unsolicited Adverse Events (AEs)
Any unsolicited AEs
|
26 Subjects
|
28 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Children Who Reported Unsolicited Adverse Events (AEs)
At least possibly related unsolicited AEs
|
9 Subjects
|
6 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Children Who Reported Unsolicited Adverse Events (AEs)
Serious AEs
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Children Who Reported Unsolicited Adverse Events (AEs)
At least possibly related Serious AEs
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Children Who Reported Unsolicited Adverse Events (AEs)
Premature withdrawals due to AEs
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: from V1/day 1 (postvaccination) through V7/study termination day 43Population: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \[SAE\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=200 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=200 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
Any unsolicited AEs
|
36 Subjects
|
39 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
At least possibly related unsolicited AEs
|
5 Subjects
|
15 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
Serious AEs
|
1 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
At least possibly related Serious AEs
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
Death
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
Premature withdrawals due to AEs
|
1 Subjects
|
4 Subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination (day 1) and 14 days after first vaccination (day 15).Population: For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.
Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=58 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=56 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
n=56 Participants
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
n=54 Participants
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
n=114 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=110 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Day 1(58,56,56,54,114,110)
|
0 Percentages of subjects
Interval 0.0 to 6.0
|
2 Percentages of subjects
Interval 0.045 to 10.0
|
0 Percentages of subjects
Interval 0.0 to 6.0
|
4 Percentages of subjects
Interval 0.0 to 13.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
3 Percentages of subjects
Interval 1.0 to 8.0
|
|
Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Day 15(58,56,56,54,114, 110)
|
100 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 93.0 to 100.0
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
SECONDARY outcome
Timeframe: Before vaccination (day 1) and 14 days after first vaccination (day 15).Population: For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.
Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=93 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=93 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
n=97 Participants
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
n=95 Participants
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
n=190 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=188 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Day 1(93,93,97,95,190,188)
|
5 Percentages of subjects
Interval 2.0 to 12.0
|
4 Percentages of subjects
Interval 1.0 to 11.0
|
1 Percentages of subjects
Interval 0.026 to 6.0
|
4 Percentages of subjects
Interval 1.0 to 10.0
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
4 Percentages of subjects
Interval 2.0 to 8.0
|
|
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Day 15 (93,93,97,95,190, 188)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
99 Percentages of subjects
Interval 94.0 to 100.0
|
99 Percentages of subjects
Interval 94.0 to 100.0
|
99 Percentages of subjects
Interval 97.0 to 100.0
|
99 Percentages of subjects
Interval 97.0 to 100.0
|
SECONDARY outcome
Timeframe: Before vaccination (day 1) and 42 days after first vaccination (day 43).Population: For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.
Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=57 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=56 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
n=56 Participants
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
n=55 Participants
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
n=113 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=111 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Day 1(57,56,56,55,113,111)
|
0 Percentages of subjects
Interval 0.0 to 6.0
|
2 Percentages of subjects
Interval 0.045 to 10.0
|
0 Percentages of subjects
Interval 0.0 to 6.0
|
4 Percentages of subjects
Interval 0.0 to 13.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
3 Percentages of subjects
Interval 1.0 to 8.0
|
|
Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Day 43 (57,56,56,55,113,111)
|
100 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
SECONDARY outcome
Timeframe: Before vaccination (day 1) and 42 days after first vaccination (day 43).Population: For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.
Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=92 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=90 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
n=96 Participants
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
n=93 Participants
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
n=188 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=183 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Day 1(92,90,96,93,188,183)
|
5 Percentages of subjects
Interval 2.0 to 12.0
|
4 Percentages of subjects
Interval 1.0 to 11.0
|
1 Percentages of subjects
Interval 0.026 to 6.0
|
4 Percentages of subjects
Interval 1.0 to 11.0
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
4 Percentages of subjects
Interval 2.0 to 8.0
|
|
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Day 43 (92,90,96,93,188,183)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
SECONDARY outcome
Timeframe: Before vaccination (day 1) and 42 days after first vaccination (day 43)Population: For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.
Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=57 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=56 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
n=56 Participants
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
n=55 Participants
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
n=113 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=111 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
GMCs of RVNA Titer 42 Days After First Vaccination in Children.
Day 1(N=57,56,56,55,113,111)
|
0.054 Concentration (IU/mL)
Interval 0.048 to 0.06
|
0.053 Concentration (IU/mL)
Interval 0.048 to 0.059
|
0.05 Concentration (IU/mL)
Interval 0.046 to 0.055
|
0.055 Concentration (IU/mL)
Interval 0.05 to 0.06
|
0.052 Concentration (IU/mL)
Interval 0.048 to 0.056
|
0.054 Concentration (IU/mL)
Interval 0.05 to 0.058
|
|
GMCs of RVNA Titer 42 Days After First Vaccination in Children.
Day 43(N=57,56,56,55,113,111)
|
13 Concentration (IU/mL)
Interval 11.0 to 15.0
|
24 Concentration (IU/mL)
Interval 20.0 to 29.0
|
13 Concentration (IU/mL)
Interval 11.0 to 16.0
|
23 Concentration (IU/mL)
Interval 19.0 to 28.0
|
13 Concentration (IU/mL)
Interval 11.0 to 15.0
|
24 Concentration (IU/mL)
Interval 21.0 to 27.0
|
SECONDARY outcome
Timeframe: Before vaccination (day 1) and 42 days after first vaccination (day 43)Population: For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.
Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Outcome measures
| Measure |
Zagreb(≥6 to ≤17 Years)
n=92 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
|
Essen(≥6 to ≤17 Years)
n=90 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥12 to ≤17 Years)
n=96 Participants
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥12 to ≤17 Years)
n=93 Participants
≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb( ≥6 to ≤17 Years)
n=188 Participants
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=183 Participants
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|---|---|
|
GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.
Day 1(92,90,96,93,188,183)
|
0.063 Concentration (IU/ml)
Interval 0.054 to 0.074
|
0.06 Concentration (IU/ml)
Interval 0.052 to 0.07
|
0.052 Concentration (IU/ml)
Interval 0.047 to 0.058
|
0.06 Concentration (IU/ml)
Interval 0.054 to 0.068
|
0.057 Concentration (IU/ml)
Interval 0.052 to 0.063
|
0.06 Concentration (IU/ml)
Interval 0.055 to 0.066
|
|
GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.
Day 43(92,90,96,93,188,183)
|
12 Concentration (IU/ml)
Interval 9.36 to 15.0
|
16 Concentration (IU/ml)
Interval 13.0 to 20.0
|
12 Concentration (IU/ml)
Interval 9.39 to 15.0
|
11 Concentration (IU/ml)
Interval 8.67 to 14.0
|
12 Concentration (IU/ml)
Interval 10.0 to 14.0
|
13 Concentration (IU/ml)
Interval 11.0 to 16.0
|
Adverse Events
Zagreb(≥6 to ≤17 Years)
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Essen(≥6 to ≤17 Years)
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Zagreb(≥51 Years)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Essen(≥51 Years)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zagreb(≥6 to ≤17 Years)
n=121 participants at risk
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=119 participants at risk
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥51 Years)
n=200 participants at risk
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
|
Essen(≥51 Years)
n=200 participants at risk
≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
0.00%
0/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
0.50%
1/200 • Number of events 1 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
0.00%
0/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
Other adverse events
| Measure |
Zagreb(≥6 to ≤17 Years)
n=121 participants at risk
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
|
Essen(≥6 to ≤17 Years)
n=119 participants at risk
≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
|
Zagreb(≥51 Years)
n=200 participants at risk
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
|
Essen(≥51 Years)
n=200 participants at risk
≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
14.9%
18/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
12.6%
15/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
4.5%
9/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
3.5%
7/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
|
General disorders
Injection Site Pain
|
39.7%
48/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
42.0%
50/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
9.5%
19/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
12.0%
24/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.6%
8/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
10.9%
13/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
2.5%
5/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
3.0%
6/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
|
Nervous system disorders
Headache
|
9.1%
11/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
8.4%
10/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
4.0%
8/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
4.5%
9/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
|
Gastrointestinal disorders
Nausea
|
5.8%
7/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
8.4%
10/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
2.0%
4/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
1.0%
2/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
|
General disorders
Injection Site Erythema
|
6.6%
8/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
1.7%
2/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
0.50%
1/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
2.5%
5/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
|
General disorders
Pyrexia
|
6.6%
8/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
2.5%
3/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
2.5%
5/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
3.5%
7/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.6%
14/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
8.4%
10/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
0.00%
0/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
1.0%
2/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
11/121 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
10.9%
13/119 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
0.00%
0/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
1.0%
2/200 • Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
|
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