Rabies Virus
Conditions
Keywords
Rabies virus
Brief summary
This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.
Detailed description
This study assessed different formulations of the modified formulation of VRVg (VRVg 2- formulations 1 \[low\], 2 \[medium\] and 3 \[high\]) tested in parallel to the initial VRVg formulation (VRVg-1) and Imovax Rabies. Immune responses were assessed at Day 14, Day 28, Day 42, and at Month 7. Safety events were also reported.
Interventions
BIOLOGICALVRVg 2
Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free
BIOLOGICALVRVg 1
Initial formulation of Purified Vero Rabies Vaccine Serum Free
BIOLOGICALImovax Rabies
Purified inactivated rabies vaccine prepared on human diploid cell cultures
BIOLOGICALHuman Rabies Immunoglobulins (HRIG)
Commercialized formulation of HRIG
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: 1. Aged 18 to less than 65 years on the day of inclusion. 2. Informed consent form had been signed and dated. 3. Able to attend all scheduled visits and to complied with all trial procedures. 4. Body Mass Index (BMI): 18.5 kilograms per meter square (Kg/m\^2) less than or equal to (\<=) BMI \<= 30 Kg/m\^2.
Exclusion criteria
An individual fulfilling any of the following criteria was to be excluded from trial enrollment: 1. Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. 2. Participation at the time of study enrollment or, planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. 3. Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 6. 4. Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine. 5. Receipt of immune globulins, blood or blood-derived products in the past 3 months. 6. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). 7. At high risk for rabies infection during the trial (e.g., veterinarians and staff, animal handlers, rabies researchers, or any others whose activities may bring them into frequent contact with rabies virus or animals who had the rabies virus). 8. Known systemic hypersensitivity to any of the vaccine or human rabies immunoglobulins (HRIG) components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. 9. Self-reported thrombocytopenia, contraindicating IM vaccination. 10. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. 11. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. 12. Current alcohol abuse or drug addiction. 13. Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion (e.g., cardiac disorders, renal disorders, auto immune disorders, diabetes, psychiatric disorders or chronic infection). 14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to \[\>=\] 100.4 Fahrenheit \>=38.0 Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. 15. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. 16. History of Guillain-Barré syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 | Day 42 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. |
| Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 | Day 0 | RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method. |
| Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 | Day 14 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. |
| Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 | Day 28 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. |
| Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 | Month 7 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. |
| Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | Day 0 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive. |
| Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | Day 14 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive. |
| Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | Day 28 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive. |
| Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | Day 42 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive. |
| Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | Month 7 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>= 0.2 IU/mL were considered as seropositive. |
| Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) | Day 0 (pre-dose) and Day 14 (7 days post-dose 3) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 7 days post 3rd vaccination (i.e., on Day 14) and pre-vaccination on Day 0. |
| Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) | Day 0 (pre-dose) and Day 28 (14 days post-dose 4) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 4th vaccination (i.e., on Day 28) and pre-vaccination on Day 0. |
| Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) | Day 0 (Pre-dose) and Day 42 (14 days Post-dose 5) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 5th vaccination (i.e., on Day 42) and pre-vaccination on Day 0. |
| Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) | Day 0 (Pre-dose) and Month 7 (6 Months Post Last Vaccination) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 6 month post last vaccination on Month 7 and pre-vaccination on Day 0. |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 | Day 0 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 | Day 14 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 | Day 28 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 | Day 42 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 | Month 7 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. |
| Number of Participants With Immediate Unsolicited Adverse Events | Within 30 Minutes After any Vaccination | An adverse event was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs). |
| Number of Participants With at Least One Solicited Injection Site Reactions | Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | A solicited reaction (SR) was an AR observed and reported under conditions (symptoms and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain, erythema and swelling at and around the injection site. |
| Number of Participants With at Least One Solicited Systemic Reactions | Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | A solicited reaction was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, headache, malaise and myalgia. |
| Number of Participants With at Least One Unsolicited Adverse Events | Within 28 Days After any vaccination | An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. |
| Number of Participants With Serious Adverse Events (SAEs) | From Day 0 up to Month 7 | An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 5 centers in the United States from 17 April 2017 to 08 January 2018.
Pre-assignment details
A total of 320 participants were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: VRVg-2 Formulation 1 VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 80 |
| Group 2:VRVg-2 Formulation 2 VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 80 |
| Group 3: VRVg-2 Formulation 3 VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 80 |
| Group 4: VRVg-1 VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 40 |
| Group 5: Imovax Rabies Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 40 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Active Vaccination Phase (Day 0-Day 56) | Lost to Follow-up | 1 | 1 | 0 | 3 | 0 |
| Active Vaccination Phase (Day 0-Day 56) | Non-compliance with the Protocol | 0 | 0 | 1 | 2 | 1 |
| Active Vaccination Phase (Day 0-Day 56) | Other Adverse Event (AE) | 1 | 1 | 0 | 1 | 2 |
| Active Vaccination Phase (Day 0-Day 56) | Voluntary Withdrawal Not Due AE | 4 | 1 | 1 | 1 | 0 |
| Follow-up Phase (Day 56 Till Month 7) | Lost to Follow-up | 4 | 1 | 4 | 2 | 3 |
| Follow-up Phase (Day 56 Till Month 7) | Non-compliance with the Protocol | 2 | 0 | 0 | 1 | 0 |
| Follow-up Phase (Day 56 Till Month 7) | Voluntary Withdrawal not due to AE | 1 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: VRVg-2 Formulation 1 | Total | Group 5: Imovax Rabies | Group 4: VRVg-1 | Group 3: VRVg-2 Formulation 3 | Group 2:VRVg-2 Formulation 2 |
|---|---|---|---|---|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 13.4 | 41.4 years STANDARD_DEVIATION 13.5 | 38.9 years STANDARD_DEVIATION 13.1 | 41.1 years STANDARD_DEVIATION 13.5 | 41.1 years STANDARD_DEVIATION 14.4 | 42.6 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 6 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 7 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 78 Participants | 7 Participants | 13 Participants | 22 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 8 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 56 Participants | 217 Participants | 28 Participants | 24 Participants | 55 Participants | 54 Participants |
| Sex: Female, Male Female | 44 Participants | 158 Participants | 22 Participants | 16 Participants | 41 Participants | 35 Participants |
| Sex: Female, Male Male | 36 Participants | 162 Participants | 18 Participants | 24 Participants | 39 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 | 0 / 80 | 0 / 39 | 0 / 41 |
| other Total, other adverse events | 40 / 80 | 39 / 80 | 45 / 80 | 22 / 39 | 28 / 41 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 | 1 / 80 | 0 / 39 | 0 / 41 |
Outcome results
Primary
Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0)
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 7 days post 3rd vaccination (i.e., on Day 14) and pre-vaccination on Day 0.
Time frame: Day 0 (pre-dose) and Day 14 (7 days post-dose 3)
Population: Analysis was performed on PPAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) | 12.7 ratio |
| Group 2:VRVg-2 Formulation 2 | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) | 17.9 ratio |
| Group 3: VRVg-2 Formulation 3 | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) | 24.8 ratio |
| Group 4: VRVg-1 | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) | 13.7 ratio |
| Group 5: Imovax Rabies | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) | 15.6 ratio |
Primary
Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0)
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 4th vaccination (i.e., on Day 28) and pre-vaccination on Day 0.
Time frame: Day 0 (pre-dose) and Day 28 (14 days post-dose 4)
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) | 31.9 ratio |
| Group 2:VRVg-2 Formulation 2 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) | 46.4 ratio |
| Group 3: VRVg-2 Formulation 3 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) | 67.0 ratio |
| Group 4: VRVg-1 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) | 30.0 ratio |
| Group 5: Imovax Rabies | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) | 48.6 ratio |
Primary
Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0)
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 5th vaccination (i.e., on Day 42) and pre-vaccination on Day 0.
Time frame: Day 0 (Pre-dose) and Day 42 (14 days Post-dose 5)
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) | 80.7 ratio |
| Group 2:VRVg-2 Formulation 2 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) | 96.8 ratio |
| Group 3: VRVg-2 Formulation 3 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) | 153 ratio |
| Group 4: VRVg-1 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) | 69.0 ratio |
| Group 5: Imovax Rabies | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) | 89.9 ratio |
Primary
Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0)
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 6 month post last vaccination on Month 7 and pre-vaccination on Day 0.
Time frame: Day 0 (Pre-dose) and Month 7 (6 Months Post Last Vaccination)
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) | 8.86 ratio |
| Group 2:VRVg-2 Formulation 2 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) | 9.71 ratio |
| Group 3: VRVg-2 Formulation 3 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) | 15.5 ratio |
| Group 4: VRVg-1 | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) | 9.27 ratio |
| Group 5: Imovax Rabies | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) | 10.1 ratio |
Primary
Number of Participants With at Least One Solicited Injection Site Reactions
A solicited reaction (SR) was an AR observed and reported under conditions (symptoms and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain, erythema and swelling at and around the injection site.
Time frame: Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Population: Analysis performed on SafAS. Here, 'number analyzed' = participants with available data for each specified category.1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. At Vaccination 2, 1 participant of Group 1 received Group 2 vaccine and thus counted in Group 2 for post-vaccination 2 safety analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema post-any vaccination | 2 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 4 | 16 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 5 | 14 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 1 | 13 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling post-any vaccination | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 2 | 12 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain post-any vaccination | 29 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 2 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 3 | 14 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 2 | 12 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain post-any vaccination | 32 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 1 | 20 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 3 | 10 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 4 | 11 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 5 | 7 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema post-any vaccination | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling post-any vaccination | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 2 | 18 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 5 | 14 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 1 | 26 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling post-any vaccination | 1 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 3 | 20 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain post-any vaccination | 38 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 1 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 4 | 17 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 1 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 1 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 2 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema post-any vaccination | 3 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 4 | 6 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 1 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain post-any vaccination | 14 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 2 | 6 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling post-any vaccination | 1 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 1 | 10 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 1 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 5 | 4 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema post-any vaccination | 1 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 3 | 4 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 1 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema post-any vaccination | 2 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Pain post-any vaccination | 24 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 1 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 4 | 11 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 2 | 10 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 5 | 10 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling post-any vaccination | 2 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 1 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 3 | 9 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Pain Post-vaccination 1 | 16 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 1 Participants |
Primary
Number of Participants With at Least One Solicited Systemic Reactions
A solicited reaction was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, headache, malaise and myalgia.
Time frame: Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Population: Analysis performed on SafAS. Here, 'number analyzed' = participants with available data for each specified category.1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. At Vaccination 2, 1 participant of Group 1 received Group 2 vaccine and thus counted in Group 2 for post-vaccination 2 safety analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-any Vaccination | 26 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 3 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 4 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 5 | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-any Vaccination | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 1 | 11 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 2 | 11 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 3 | 14 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 4 | 6 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 5 | 7 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-any Vaccination | 26 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 1 | 14 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 2 | 8 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 3 | 8 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 4 | 6 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 5 | 5 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-any Vaccination | 25 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 16 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 9 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 8 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 9 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 7 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-any Vaccination | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 3 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 7 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 4 | 4 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 5 | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-any Vaccination | 12 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 14 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 5 | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 2 | 3 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-any Vaccination | 22 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 7 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 5 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-any Vaccination | 13 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 4 | 4 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 4 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 3 | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 1 | 8 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 3 | 4 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 3 | 4 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 5 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 1 | 8 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 2 | 3 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 15 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 1 | 15 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 3 | 3 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 5 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 4 | 10 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-any Vaccination | 20 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 3 | 2 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 5 | 5 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 2 | 5 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 4 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 10 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 3 | 5 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 6 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 4 | 9 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 5 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 5 | 7 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-any Vaccination | 20 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-any Vaccination | 17 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 2 | 7 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 1 | 10 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 5 | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-any Vaccination | 2 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 4 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 5 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-any Vaccination | 9 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 6 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 1 | 5 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 2 | 1 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 3 | 2 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 4 | 3 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 5 | 1 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 3 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-any Vaccination | 11 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 1 | 6 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 3 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 2 | 2 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 3 | 3 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 4 | 6 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 4 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 5 | 4 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-any Vaccination | 11 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-any Vaccination | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 5 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 3 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 3 | 5 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 2 | 10 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 1 | 9 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 3 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-any Vaccination | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 9 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-any Vaccination | 16 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 5 | 7 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 1 | 9 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-any Vaccination | 15 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 4 | 5 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 3 | 10 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 5 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 13 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Headache Post-vaccination 2 | 9 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 8 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 5 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 5 | 4 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Malaise Post-vaccination 4 | 6 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Fever Post-vaccination 4 | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-any Vaccination | 19 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 9 Participants |
Primary
Number of Participants With at Least One Unsolicited Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination.
Time frame: Within 28 Days After any vaccination
Population: Analysis was performed on SafAS. 1 participant of Group 4 received Imovax Rabies vaccine, and thus counted in Group 5 for safety analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Number of Participants With at Least One Unsolicited Adverse Events | 11 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With at Least One Unsolicited Adverse Events | 11 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With at Least One Unsolicited Adverse Events | 20 Participants |
| Group 4: VRVg-1 | Number of Participants With at Least One Unsolicited Adverse Events | 10 Participants |
| Group 5: Imovax Rabies | Number of Participants With at Least One Unsolicited Adverse Events | 18 Participants |
Primary
Number of Participants With Immediate Unsolicited Adverse Events
An adverse event was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).
Time frame: Within 30 Minutes After any Vaccination
Population: Analysis was performed on safety analysis set (SafAS) that included participant who had received at least one least one dose of the study vaccine and were analyzed according to the actual treatment received. 1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AE | 0 Participants |
| Group 1: VRVg-2 Formulation 1 | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AR | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AE | 1 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AR | 1 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AE | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AR | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AR | 0 Participants |
| Group 4: VRVg-1 | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AE | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AE | 2 Participants |
| Group 5: Imovax Rabies | Number of Participants With Immediate Unsolicited Adverse Events | Immediate Unsolicited AR | 2 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event.
Time frame: From Day 0 up to Month 7
Population: Analysis was performed on SafAS. 1 participant of Group 4 received Imovax Rabies vaccine, and thus counted in Group 5 for safety analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Group 2:VRVg-2 Formulation 2 | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Group 3: VRVg-2 Formulation 3 | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 4: VRVg-1 | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Group 5: Imovax Rabies | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Time frame: Day 0
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 | 0 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 | 0 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 | 0 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 | 0 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 | 0 percentage of participants |
Primary
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Time frame: Day 14
Population: Analysis was performed on PPAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 | 79.2 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 | 89.3 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 | 93.0 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 | 82.9 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 | 85.3 percentage of participants |
Primary
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Time frame: Day 28
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 | 92.8 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 | 94.6 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 | 98.6 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 | 100 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 | 93.9 percentage of participants |
Primary
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Time frame: Day 42
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 | 97.1 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 | 93.2 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 | 94.1 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 | 100 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 | 93.9 percentage of participants |
Primary
Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7
Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported.
Time frame: Month 7
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 | 95.1 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 | 88.7 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 | 100 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 | 85.2 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 | 93.5 percentage of participants |
Primary
Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
Time frame: Day 0
Population: Analysis was performed on PPAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.2 IU/mL | 0 percentage of participants |
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.5 IU/mL | 0 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.2 IU/mL | 0 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.5 IU/mL | 0 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.2 IU/mL | 0 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.5 IU/mL | 0 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.5 IU/mL | 0 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.2 IU/mL | 0 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.2 IU/mL | 0 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer >= 0.5 IU/mL | 0 percentage of participants |
Primary
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
Time frame: Day 14
Population: Analysis was performed on PPAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.2 IU/mL | 93.1 percentage of participants |
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.5 IU/mL | 75.0 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.2 IU/mL | 96.0 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.5 IU/mL | 81.3 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.2 IU/mL | 97.2 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.5 IU/mL | 90.1 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.5 IU/mL | 80.0 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.2 IU/mL | 97.1 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.2 IU/mL | 97.1 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer >= 0.5 IU/mL | 88.2 percentage of participants |
Primary
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
Time frame: Day 28
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.2 IU/mL | 98.5 percentage of participants |
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.5 IU/mL | 93.9 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.2 IU/mL | 98.6 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.5 IU/mL | 95.9 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.2 IU/mL | 100 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.5 IU/mL | 100 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.5 IU/mL | 86.2 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.2 IU/mL | 96.6 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.2 IU/mL | 100 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titers >= 0.5 IU/mL | 100 percentage of participants |
Primary
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
Time frame: Day 42
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.2 IU/mL | 100 percentage of participants |
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.5 IU/mL | 100 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.2 IU/mL | 98.6 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.5 IU/mL | 98.6 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.2 IU/mL | 100 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.5 IU/mL | 100 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.5 IU/mL | 96.7 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.2 IU/mL | 96.7 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.2 IU/mL | 100 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titers >= 0.5 IU/mL | 100 percentage of participants |
Primary
Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>= 0.2 IU/mL were considered as seropositive.
Time frame: Month 7
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.2 IU/mL | 93.4 percentage of participants |
| Group 1: VRVg-2 Formulation 1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.5 IU/mL | 70.5 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.2 IU/mL | 93.0 percentage of participants |
| Group 2:VRVg-2 Formulation 2 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.5 IU/mL | 77.5 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.2 IU/mL | 100 percentage of participants |
| Group 3: VRVg-2 Formulation 3 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.5 IU/mL | 92.2 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.5 IU/mL | 74.1 percentage of participants |
| Group 4: VRVg-1 | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.2 IU/mL | 92.6 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.2 IU/mL | 87.1 percentage of participants |
| Group 5: Imovax Rabies | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titers >= 0.5 IU/mL | 74.2 percentage of participants |
Primary
Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Time frame: Day 14
Population: Analysis was performed on PPAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 | 1.28 international units per milliliter |
| Group 2:VRVg-2 Formulation 2 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 | 1.79 international units per milliliter |
| Group 3: VRVg-2 Formulation 3 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 | 2.52 international units per milliliter |
| Group 4: VRVg-1 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 | 1.38 international units per milliliter |
| Group 5: Imovax Rabies | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 | 1.56 international units per milliliter |
Primary
Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Time frame: Day 28
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 | 3.22 international units per milliliter |
| Group 2:VRVg-2 Formulation 2 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 | 4.64 international units per milliliter |
| Group 3: VRVg-2 Formulation 3 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 | 6.81 international units per milliliter |
| Group 4: VRVg-1 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 | 3.04 international units per milliliter |
| Group 5: Imovax Rabies | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 | 4.86 international units per milliliter |
Primary
Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Time frame: Day 42
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 | 8.14 international units per milliliter |
| Group 2:VRVg-2 Formulation 2 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 | 9.68 international units per milliliter |
| Group 3: VRVg-2 Formulation 3 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 | 15.6 international units per milliliter |
| Group 4: VRVg-1 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 | 6.98 international units per milliliter |
| Group 5: Imovax Rabies | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 | 8.99 international units per milliliter |
Primary
Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Time frame: Month 7
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 | 0.894 international units per milliliter |
| Group 2:VRVg-2 Formulation 2 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 | 0.971 international units per milliliter |
| Group 3: VRVg-2 Formulation 3 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 | 1.58 international units per milliliter |
| Group 4: VRVg-1 | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 | 0.939 international units per milliliter |
| Group 5: Imovax Rabies | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 | 1.01 international units per milliliter |
Primary
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0
RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method.
Time frame: Day 0
Population: Per-Protocol Analysis Set (PPAS): participants who received at least one dose of the study vaccine without protocol deviations before Day 14 (i.e., 7 days after the 3rd vaccine injection).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 | 0.101 international units per milliliter |
| Group 2:VRVg-2 Formulation 2 | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 | 0.100 international units per milliliter |
| Group 3: VRVg-2 Formulation 3 | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 | 0.102 international units per milliliter |
| Group 4: VRVg-1 | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 | 0.101 international units per milliliter |
| Group 5: Imovax Rabies | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 | 0.100 international units per milliliter |