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A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01680016
Recruitment Status : Completed
First Posted : September 6, 2012
Results First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Rabies
Interventions Biological: Zagreb
Biological: Essen
Enrollment 644
Recruitment Details Subjects were enrolled at Mengshan CDC
Pre-assignment Details All enrolled subjects were included in the trial
Arm/Group Title Zagreb(≥6 to ≤17 Years) Essen(≥6 to ≤17 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Hide Arm/Group Description ≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22 ≥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 ≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22 ≥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
Period Title: Overall Study
Started 121 122 201 200
Completed 115 114 196 195
Not Completed 6 8 5 5
Reason Not Completed
Adverse Event             0             0             1             4
The Subject went out of The Trial             1             0             3             0
Protocol Violation             0             1             0             0
Withdrawal by Subject             5             7             1             1
Arm/Group Title Zagreb Essen Total
Hide Arm/Group Description Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22 Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29 Total of all reporting groups
Overall Number of Baseline Participants 322 322 644
Hide Baseline Analysis Population Description
Enrolled set:All subjects who had signed an informed consent, undergone screening procedure(s) and were randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 322 participants 322 participants 644 participants
Children (≥6 to ≤17 Years) 11  (3.0) 10.8  (2.9) 10.9  (3.0)
Older Adults (≥51 Years) 62.1  (6.5) 61.9  (6.8) 62.0  (6.6)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 322 participants 322 participants 644 participants
Female (≥6 to ≤17 Years) 49 76 125
Male (≥6 to ≤17 Years) 72 46 118
Female (≥51 Years) 118 123 241
Male (≥51 Years) 83 77 160
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Before vaccination (day 1) and 14 days after first vaccination (day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zagreb(≥6 to ≤17 Years) Essen(≥6 to ≤17 Years)
Hide Arm/Group Description:
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
≥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
Overall Number of Participants Analyzed 114 110
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Day 1
0.052
(0.048 to 0.056)
0.054
(0.05 to 0.058)
Day 15
12
(10 to 14)
14
(12 to 16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zagreb(≥6 to ≤17 Years), Essen(≥6 to ≤17 Years)
Comments To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of GMCs between two groups(Day 15)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.69 to 1.02
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Before vaccination (day 1) and 14 days after first vaccination (day 15).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PP set.
Arm/Group Title Zagreb(≥51 Years) Essen(≥51 Years)
Hide Arm/Group Description:
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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 Number of Participants Analyzed 190 188
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Day 1
0.057
(0.052 to 0.063)
0.06
(0.055 to 0.066)
Day 15
8.57
(7.34 to 10)
7.89
(6.75 to 9.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zagreb(≥51 Years), Essen(≥51 Years)
Comments To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of GMCs between two groups(Day 15)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.87 to 1.35
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Hide Description 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.
Time Frame Days 1 to 7 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
Arm/Group Title Zagreb(≥6 to ≤11 Years) Essen(≥6 to ≤11 Years) Zagreb(≥12 to ≤17 Years) Essen(≥12 to ≤17 Years) Zagreb( ≥6 to ≤17 Years) Essen(≥6 to ≤17 Years)
Hide Arm/Group Description:
≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥6 to ≤11 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
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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
Overall Number of Participants Analyzed 60 59 61 60 121 119
Measure Type: Number
Unit of Measure: Subjects
Injection Site Erythema(N=59,58,60,60,119,118) 2 1 0 0 2 1
Injection Site Induration(N=59,58,60,60,119,118) 1 0 1 0 2 0
Injection Site Pain(N=59,58,60,60,119,118) 21 18 24 29 45 47
Nausea(N=59,58,60,60,119,118) 2 4 5 6 7 10
Myalgia(N=59,58,60,60,119,118) 4 4 7 9 11 13
Arthralgia(N=59,58,60,60,119,118) 1 0 2 1 3 1
Headache(N=59,58,60,60,119,118) 4 4 7 6 11 10
Fatigue(N=59,58,60,60,119,118) 8 4 10 11 18 15
Loss of Appetite(N=59,58,60,60,119,118) 7 3 7 7 14 10
Body Temp. (≥38°C)(N=59,58,60,60,119,118) 6 3 2 0 8 3
Low Grade Fever(N=59,58,60,60,119,118) 6 7 11 11 17 18
Medium Grade Fever(N=59,58,60,60,119,118) 9 5 4 2 13 7
High Grade Fever(N=59,58,60,60,119,118) 0 0 0 0 0 0
Analge,Antipyr Used(N=59,58,60,60,119,118) 7 4 4 4 11 8
4.Primary Outcome
Title Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Hide Description 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.
Time Frame Days 1 to 7 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set
Arm/Group Title Zagreb(≥51 to ≤60 Years) Essen(≥51 to ≤60 Years) Zagreb(≥61 Years) Essen(≥61 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Hide Arm/Group Description:
≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥51 to ≤60 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
≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥61 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
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥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 Number of Participants Analyzed 100 100 100 100 200 200
Measure Type: Number
Unit of Measure: Subjects
Injection Site Erythema(N=98,100,99,100,197,200) 1 1 0 2 1 3
Injection Site Induration(N=98,100,99,100,197,200) 1 1 0 0 1 1
Injection Site Pain(N=98,100,99,100,197,200) 9 12 9 10 18 22
Nausea(N=98,100,99,100,197,200) 1 0 1 2 2 2
Myalgia(N=98,100,99,100,197,200) 0 0 0 2 0 2
Arthralgia(N=98,100,99,100,197,200) 0 2 3 1 3 3
Headache(N=98,100,99,100,197,200) 4 2 3 6 7 8
Fatigue(N=98,100,99,100,197,200) 3 4 6 3 9 7
Loss of Appetite(N=98,100,99,100,197,200) 0 1 0 1 0 2
Body Temp.(≥38°C)(N=98,100,99,100,197,200) 0 1 5 4 5 5
Low Grade Fever(N=98,100,99,100,197,200) 3 5 3 6 6 11
Medium Grade Fever(N=98,100,99,100,197,200) 1 2 5 6 6 8
High Grade Fever(N=98,100,99,100,197,200) 0 0 1 0 1 0
Analgesic,Antipyretic use(N=98,100,99,100,197,200) 6 6 7 9 13 15
5.Primary Outcome
Title Number of Children Who Reported Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame From V1/day 1 (postvaccination) through V7/study termination day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
Arm/Group Title Zagreb(≥6 to ≤17 Years) Essen(≥6 to ≤17 Years)
Hide Arm/Group Description:
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
≥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
Overall Number of Participants Analyzed 121 119
Measure Type: Number
Unit of Measure: Subjects
Any unsolicited AEs 26 28
At least possibly related unsolicited AEs 9 6
Serious AEs 0 0
At least possibly related Serious AEs 0 0
Death 0 0
Premature withdrawals due to AEs 0 0
6.Primary Outcome
Title Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame from V1/day 1 (postvaccination) through V7/study termination day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
Arm/Group Title Zagreb(≥51 Years) Essen(≥51 Years)
Hide Arm/Group Description:
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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 Number of Participants Analyzed 200 200
Measure Type: Number
Unit of Measure: Subjects
Any unsolicited AEs 36 39
At least possibly related unsolicited AEs 5 15
Serious AEs 1 0
At least possibly related Serious AEs 0 0
Death 0 0
Premature withdrawals due to AEs 1 4
7.Secondary Outcome
Title Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Hide Description 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.
Time Frame Before vaccination (day 1) and 14 days after first vaccination (day 15).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zagreb(≥6 to ≤11 Years) Essen(≥6 to ≤11 Years) Zagreb(≥12 to ≤17 Years) Essen(≥12 to ≤17 Years) Zagreb( ≥6 to ≤17 Years) Essen(≥6 to ≤17 Years)
Hide Arm/Group Description:
≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥6 to ≤11 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
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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
Overall Number of Participants Analyzed 58 56 56 54 114 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1(58,56,56,54,114,110)
0
(0 to 6)
2
(0.045 to 10)
0
(0 to 6)
4
(0 to 13)
0
(0 to 3)
3
(1 to 8)
Day 15(58,56,56,54,114, 110)
100
(94 to 100)
100
(94 to 100)
100
(94 to 100)
100
(93 to 100)
100
(97 to 100)
100
(97 to 100)
8.Secondary Outcome
Title Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Hide Description 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.
Time Frame Before vaccination (day 1) and 14 days after first vaccination (day 15).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zagreb(≥51 to ≤60 Years) Essen(≥51 to ≤60 Years) Zagreb(≥61 Years) Essen(≥61 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Hide Arm/Group Description:
≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥51 to ≤60 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
≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥61 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
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥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 Number of Participants Analyzed 93 93 97 95 190 188
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1(93,93,97,95,190,188)
5
(2 to 12)
4
(1 to 11)
1
(0.026 to 6)
4
(1 to 10)
3
(1 to 7)
4
(2 to 8)
Day 15 (93,93,97,95,190, 188)
100
(96 to 100)
100
(96 to 100)
99
(94 to 100)
99
(94 to 100)
99
(97 to 100)
99
(97 to 100)
9.Secondary Outcome
Title Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Hide Description 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.
Time Frame Before vaccination (day 1) and 42 days after first vaccination (day 43).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zagreb(≥6 to ≤11 Years) Essen(≥6 to ≤11 Years) Zagreb(≥12 to ≤17 Years) Essen(≥12 to ≤17 Years) Zagreb( ≥6 to ≤17 Years) Essen(≥6 to ≤17 Years)
Hide Arm/Group Description:
≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥6 to ≤11 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
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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
Overall Number of Participants Analyzed 57 56 56 55 113 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1(57,56,56,55,113,111)
0
(0 to 6)
2
(0.045 to 10)
0
(0 to 6)
4
(0 to 13)
0
(0 to 3)
3
(1 to 8)
Day 43 (57,56,56,55,113,111)
100
(94 to 100)
100
(94 to 100)
100
(94 to 100)
100
(94 to 100)
100
(97 to 100)
100
(97 to 100)
10.Secondary Outcome
Title Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Hide Description 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.
Time Frame Before vaccination (day 1) and 42 days after first vaccination (day 43).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zagreb(≥51 to ≤60 Years) Essen(≥51 to ≤60 Years) Zagreb(≥61 Years) Essen(≥61 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Hide Arm/Group Description:
≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥51 to ≤60 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
≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥61 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
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥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 Number of Participants Analyzed 92 90 96 93 188 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1(92,90,96,93,188,183)
5
(2 to 12)
4
(1 to 11)
1
(0.026 to 6)
4
(1 to 11)
3
(1 to 7)
4
(2 to 8)
Day 43 (92,90,96,93,188,183)
100
(96 to 100)
100
(96 to 100)
100
(96 to 100)
100
(96 to 100)
100
(98 to 100)
100
(98 to 100)
11.Secondary Outcome
Title GMCs of RVNA Titer 42 Days After First Vaccination in Children.
Hide Description 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.
Time Frame Before vaccination (day 1) and 42 days after first vaccination (day 43)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zagreb(≥6 to ≤11 Years) Essen(≥6 to ≤11 Years) Zagreb(≥12 to ≤17 Years) Essen(≥12 to ≤17 Years) Zagreb( ≥6 to ≤17 Years) Essen(≥6 to ≤17 Years)
Hide Arm/Group Description:
≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥6 to ≤11 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
≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
≥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
Overall Number of Participants Analyzed 57 56 56 55 113 111
Geometric Mean (95% Confidence Interval)
Unit of Measure: Concentration (IU/mL)
Day 1(N=57,56,56,55,113,111)
0.054
(0.048 to 0.06)
0.053
(0.048 to 0.059)
0.05
(0.046 to 0.055)
0.055
(0.05 to 0.06)
0.052
(0.048 to 0.056)
0.054
(0.05 to 0.058)
Day 43(N=57,56,56,55,113,111)
13
(11 to 15)
24
(20 to 29)
13
(11 to 16)
23
(19 to 28)
13
(11 to 15)
24
(21 to 27)
12.Secondary Outcome
Title GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.
Hide Description 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.
Time Frame Before vaccination (day 1) and 42 days after first vaccination (day 43)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zagreb(≥51 to ≤60 Years) Essen(≥51 to ≤60 Years) Zagreb(≥61 Years) Essen(≥61 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Hide Arm/Group Description:
≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥51 to ≤60 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
≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥61 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
≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
≥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 Number of Participants Analyzed 92 90 96 93 188 183
Geometric Mean (95% Confidence Interval)
Unit of Measure: Concentration (IU/ml)
Day 1(92,90,96,93,188,183)
0.063
(0.054 to 0.074)
0.06
(0.052 to 0.07)
0.052
(0.047 to 0.058)
0.06
(0.054 to 0.068)
0.057
(0.052 to 0.063)
0.06
(0.055 to 0.066)
Day 43(92,90,96,93,188,183)
12
(9.36 to 15)
16
(13 to 20)
12
(9.39 to 15)
11
(8.67 to 14)
12
(10 to 14)
13
(11 to 16)
Time Frame Whole study period (From day 1 to day 43)
Adverse Event Reporting Description 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
 
Arm/Group Title Zagreb(≥6 to ≤17 Years) Essen(≥6 to ≤17 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Hide Arm/Group Description ≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22 ≥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 ≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22 ≥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
All-Cause Mortality
Zagreb(≥6 to ≤17 Years) Essen(≥6 to ≤17 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Zagreb(≥6 to ≤17 Years) Essen(≥6 to ≤17 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/121 (0.00%)      0/119 (0.00%)      1/200 (0.50%)      0/200 (0.00%)    
Gastrointestinal disorders         
Pancreatitis Acute  1  0/121 (0.00%)  0 0/119 (0.00%)  0 1/200 (0.50%)  1 0/200 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0v
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zagreb(≥6 to ≤17 Years) Essen(≥6 to ≤17 Years) Zagreb(≥51 Years) Essen(≥51 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   64/121 (52.89%)      63/119 (52.94%)      19/200 (9.50%)      24/200 (12.00%)    
Gastrointestinal disorders         
Nausea  1  7/121 (5.79%)  10/119 (8.40%)  4/200 (2.00%)  2/200 (1.00%) 
General disorders         
Fatigue  1  18/121 (14.88%)  15/119 (12.61%)  9/200 (4.50%)  7/200 (3.50%) 
Injection Site Pain  1  48/121 (39.67%)  50/119 (42.02%)  19/200 (9.50%)  24/200 (12.00%) 
Injection Site Erythema  1  8/121 (6.61%)  2/119 (1.68%)  1/200 (0.50%)  5/200 (2.50%) 
Pyrexia  1  8/121 (6.61%)  3/119 (2.52%)  5/200 (2.50%)  7/200 (3.50%) 
Infections and infestations         
Upper Respiratory Tract Infection * 1  8/121 (6.61%)  13/119 (10.92%)  5/200 (2.50%)  6/200 (3.00%) 
Metabolism and nutrition disorders         
Decreased Appetite  1  14/121 (11.57%)  10/119 (8.40%)  0/200 (0.00%)  2/200 (1.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  11/121 (9.09%)  13/119 (10.92%)  0/200 (0.00%)  2/200 (1.00%) 
Nervous system disorders         
Headache  1  11/121 (9.09%)  10/119 (8.40%)  8/200 (4.00%)  9/200 (4.50%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0v
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01680016    
Other Study ID Numbers: V49_24
First Submitted: September 3, 2012
First Posted: September 6, 2012
Results First Submitted: January 7, 2014
Results First Posted: May 20, 2014
Last Update Posted: May 20, 2014