Rabies
Conditions
Keywords
Rabies virus, postexposure, vaccine schedule, children, older adults
Brief summary
This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.
Detailed description
This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1) and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2 (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine will be administered on study Day 1. 240 children and 400 older adults, a total of 640, is planned to be enrolled into the study. Subjects will be divided further into age subsets of equal numbers within each age cohort (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of age and 61 years of age and older. Within each age subset, subjects will be assigned randomly in a 1:1 ratio. The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1) schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric mean titers (GMC), and the secondary objective is to assess the percent of subjects with rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day 15) for each schedule and age cohort
Interventions
BIOLOGICALZagreb
Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
BIOLOGICALEssen
Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals between 6-17 years of age and 51 years of age or older * Individuals who were in good health * Provided consent, complied with study procedures and duration of follow-up
Exclusion criteria
* Contraindications to vaccination with rabies vaccine * Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination * Known hypersensitivity to the components of the vaccine * Previously received any rabies vaccine or immune globulin * Previous or planned treatment with antimalarial medications * History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse within the past 2 years, malignancy * Female subjects who were pregnant or unwilling to practice acceptable birth control methods * Individuals enrolled or plans to enroll in another investigational trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | from V1/day 1 (postvaccination) through V7/study termination day 43 | 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. |
| 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. | Before vaccination (day 1) and 14 days after first vaccination (day 15) | 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. |
| 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 | Before vaccination (day 1) and 14 days after first vaccination (day 15). | 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. |
| Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Days 1 to 7 postvaccination | 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. |
| Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Days 1 to 7 postvaccination | 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. |
| Number of Children Who Reported Unsolicited Adverse Events (AEs) | From V1/day 1 (postvaccination) through V7/study termination day 43 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur | Before vaccination (day 1) and 14 days after first vaccination (day 15). | 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. |
| Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur | Before vaccination (day 1) and 14 days after first vaccination (day 15). | 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. |
| Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur | Before vaccination (day 1) and 42 days after first vaccination (day 43). | 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. |
| Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur | Before vaccination (day 1) and 42 days after first vaccination (day 43). | 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. |
| GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Before vaccination (day 1) and 42 days after first vaccination (day 43) | 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. |
| GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Before vaccination (day 1) and 42 days after first vaccination (day 43) | 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. |
Countries
China
Participant flow
Recruitment details
Subjects were enrolled at Mengshan CDC
Pre-assignment details
All enrolled subjects were included in the trial
Participants by arm
| Arm | Count |
|---|---|
| Zagreb Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22 | 322 |
| Essen Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29 | 322 |
| Total | 644 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 4 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | The Subject went out of The Trial | 1 | 0 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 7 | 1 | 1 |
Baseline characteristics
| Characteristic | Zagreb | Essen | Total |
|---|---|---|---|
| Age, Continuous Children (≥6 to ≤17 Years) | 11 years STANDARD_DEVIATION 3 | 10.8 years STANDARD_DEVIATION 2.9 | 10.9 years STANDARD_DEVIATION 3 |
| Age, Continuous Older Adults (≥51 Years) | 62.1 years STANDARD_DEVIATION 6.5 | 61.9 years STANDARD_DEVIATION 6.8 | 62.0 years STANDARD_DEVIATION 6.6 |
| Sex/Gender, Customized Female (≥51 Years) | 118 Subjects | 123 Subjects | 241 Subjects |
| Sex/Gender, Customized Female (≥6 to ≤17 Years) | 49 Subjects | 76 Subjects | 125 Subjects |
| Sex/Gender, Customized Male (≥51 Years) | 83 Subjects | 77 Subjects | 160 Subjects |
| Sex/Gender, Customized Male (≥6 to ≤17 Years) | 72 Subjects | 46 Subjects | 118 Subjects |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 64 / 121 | 63 / 119 | 19 / 200 | 24 / 200 |
| serious Total, serious adverse events | 0 / 121 | 0 / 119 | 1 / 200 | 0 / 200 |
Outcome results
Primary
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.
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)
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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 | 0.054 IU/mL |
| Essen(≥6 to ≤17 Years) | 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 | 14 IU/mL |
Comparison: 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 years95% CI: [0.69, 1.02]ANOVA
Primary
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
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).
Population: Analysis was done on the PP set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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 | 0.06 IU/mL |
| Essen(≥6 to ≤17 Years) | 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 | 7.89 IU/mL |
Comparison: 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 years95% CI: [0.87, 1.35]ANOVA
Primary
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
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
Population: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Fatigue(N=59,58,60,60,119,118) | 4 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Arthralgia(N=59,58,60,60,119,118) | 0 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 0 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 1 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 5 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 18 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 4 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 7 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 3 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Nausea(N=59,58,60,60,119,118) | 4 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 3 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Nausea(N=59,58,60,60,119,118) | 5 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 0 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 24 Subjects |
| Zagreb(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Myalgia(N=59,58,60,60,119,118) | 7 Subjects |
| Zagreb(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Arthralgia(N=59,58,60,60,119,118) | 2 Subjects |
| Zagreb(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Headache(N=59,58,60,60,119,118) | 7 Subjects |
| Zagreb(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Fatigue(N=59,58,60,60,119,118) | 10 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 2 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 11 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 4 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 4 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 0 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 0 Subjects |
| Essen(≥12 to ≤17 Years) | 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 |
| Essen(≥12 to ≤17 Years) | 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) | 4 Subjects |
| Essen(≥12 to ≤17 Years) | 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 |
| Essen(≥12 to ≤17 Years) | 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) | 29 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 11 Subjects |
| Essen(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Headache(N=59,58,60,60,119,118) | 6 Subjects |
| Essen(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Fatigue(N=59,58,60,60,119,118) | 11 Subjects |
| Essen(≥12 to ≤17 Years) | 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 |
| Essen(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Myalgia(N=59,58,60,60,119,118) | 9 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 0 Subjects |
| Essen(≥12 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Nausea(N=59,58,60,60,119,118) | 6 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 2 Subjects |
| Zagreb( ≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Myalgia(N=59,58,60,60,119,118) | 11 Subjects |
| Zagreb( ≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Fatigue(N=59,58,60,60,119,118) | 18 Subjects |
| Zagreb( ≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Nausea(N=59,58,60,60,119,118) | 7 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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) | 14 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 8 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 45 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 17 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 2 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 13 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 11 Subjects |
| Zagreb( ≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Arthralgia(N=59,58,60,60,119,118) | 3 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Headache(N=59,58,60,60,119,118) | 11 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Myalgia(N=59,58,60,60,119,118) | 13 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 7 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 10 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 1 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Headache(N=59,58,60,60,119,118) | 10 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Nausea(N=59,58,60,60,119,118) | 10 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 8 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 18 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 0 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Fatigue(N=59,58,60,60,119,118) | 15 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 3 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 47 Subjects |
Primary
Number of Children Who Reported Unsolicited Adverse Events (AEs)
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
Population: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 26 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | At least possibly related unsolicited AEs | 9 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | Serious AEs | 0 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | At least possibly related Serious AEs | 0 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | Death | 0 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | Premature withdrawals due to AEs | 0 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | Death | 0 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 28 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | At least possibly related Serious AEs | 0 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | At least possibly related unsolicited AEs | 6 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | Premature withdrawals due to AEs | 0 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Children Who Reported Unsolicited Adverse Events (AEs) | Serious AEs | 0 Subjects |
Primary
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
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
Population: Analysis was done on the safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 4 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 12 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 5 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 1 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 0 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 1 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 0 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 0 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 3 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 3 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 6 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 5 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 5 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 1 Subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 7 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 4 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 1 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 9 Subjects |
| Essen(≥12 to ≤17 Years) | 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 |
| Essen(≥12 to ≤17 Years) | 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) | 10 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 6 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 6 Subjects |
| Essen(≥12 to ≤17 Years) | 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 |
| Essen(≥12 to ≤17 Years) | 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) | 1 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 0 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥12 to ≤17 Years) | 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) | 6 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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) | 9 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 2 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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) | 5 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 18 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 6 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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) | 6 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 13 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 3 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 1 Subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 7 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 8 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 3 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 8 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 2 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 15 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 3 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 11 Subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 7 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 5 Subjects |
| Essen(≥6 to ≤17 Years) | 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) | 22 Subjects |
Primary
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
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
Population: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 36 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | At least possibly related unsolicited AEs | 5 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | Serious AEs | 1 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | At least possibly related Serious AEs | 0 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | Death | 0 Subjects |
| Zagreb(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | Premature withdrawals due to AEs | 1 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | Death | 0 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 39 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | At least possibly related Serious AEs | 0 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | At least possibly related unsolicited AEs | 15 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | Premature withdrawals due to AEs | 4 Subjects |
| Essen(≥6 to ≤17 Years) | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | Serious AEs | 0 Subjects |
Secondary
GMCs of RVNA Titer 42 Days After First Vaccination in Children.
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)
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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) |
| Zagreb(≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 43(N=57,56,56,55,113,111) | 13 Concentration (IU/mL) |
| Essen(≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 1(N=57,56,56,55,113,111) | 0.053 Concentration (IU/mL) |
| Essen(≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 43(N=57,56,56,55,113,111) | 24 Concentration (IU/mL) |
| Zagreb(≥12 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 1(N=57,56,56,55,113,111) | 0.05 Concentration (IU/mL) |
| Zagreb(≥12 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 43(N=57,56,56,55,113,111) | 13 Concentration (IU/mL) |
| Essen(≥12 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 1(N=57,56,56,55,113,111) | 0.055 Concentration (IU/mL) |
| Essen(≥12 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 43(N=57,56,56,55,113,111) | 23 Concentration (IU/mL) |
| Zagreb( ≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 1(N=57,56,56,55,113,111) | 0.052 Concentration (IU/mL) |
| Zagreb( ≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 43(N=57,56,56,55,113,111) | 13 Concentration (IU/mL) |
| Essen(≥6 to ≤17 Years) | 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) |
| Essen(≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Day 43(N=57,56,56,55,113,111) | 24 Concentration (IU/mL) |
Secondary
GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.
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)
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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) |
| Zagreb(≥6 to ≤17 Years) | 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) |
| Essen(≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Day 1(92,90,96,93,188,183) | 0.06 Concentration (IU/ml) |
| Essen(≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Day 43(92,90,96,93,188,183) | 16 Concentration (IU/ml) |
| Zagreb(≥12 to ≤17 Years) | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Day 1(92,90,96,93,188,183) | 0.052 Concentration (IU/ml) |
| Zagreb(≥12 to ≤17 Years) | 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) |
| Essen(≥12 to ≤17 Years) | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Day 1(92,90,96,93,188,183) | 0.06 Concentration (IU/ml) |
| Essen(≥12 to ≤17 Years) | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Day 43(92,90,96,93,188,183) | 11 Concentration (IU/ml) |
| Zagreb( ≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Day 1(92,90,96,93,188,183) | 0.057 Concentration (IU/ml) |
| Zagreb( ≥6 to ≤17 Years) | 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) |
| Essen(≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Day 1(92,90,96,93,188,183) | 0.06 Concentration (IU/ml) |
| Essen(≥6 to ≤17 Years) | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Day 43(92,90,96,93,188,183) | 13 Concentration (IU/ml) |
Secondary
Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
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).
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 2 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Essen(≥12 to ≤17 Years) | 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) | 4 Percentages of subjects |
| Essen(≥12 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 3 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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 |
Secondary
Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
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).
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 2 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Essen(≥12 to ≤17 Years) | 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) | 4 Percentages of subjects |
| Essen(≥12 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 3 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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 |
Secondary
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
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).
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 4 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 1 Percentages of subjects |
| Zagreb(≥12 to ≤17 Years) | 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) | 99 Percentages of subjects |
| Essen(≥12 to ≤17 Years) | 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) | 4 Percentages of subjects |
| Essen(≥12 to ≤17 Years) | 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) | 99 Percentages of subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 3 Percentages of subjects |
| Zagreb( ≥6 to ≤17 Years) | 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) | 99 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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) | 4 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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) | 99 Percentages of subjects |
Secondary
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
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).
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | 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 |
| Zagreb(≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 4 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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 |
| Zagreb(≥12 to ≤17 Years) | 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) | 1 Percentages of subjects |
| Zagreb(≥12 to ≤17 Years) | 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 |
| Essen(≥12 to ≤17 Years) | 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) | 4 Percentages of subjects |
| Essen(≥12 to ≤17 Years) | 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 |
| Zagreb( ≥6 to ≤17 Years) | 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) | 3 Percentages of subjects |
| Zagreb( ≥6 to ≤17 Years) | 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 |
| Essen(≥6 to ≤17 Years) | 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) | 4 Percentages of subjects |
| Essen(≥6 to ≤17 Years) | 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 |