Rabies (Healthy Volunteers)
Conditions
Brief summary
Primary Objective: To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (\>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection. Secondary Objective: * To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection. * To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer \>= 0.5 IU/mL at Day 28 was at least 95 percent (%). * To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).
Detailed description
Study duration per participant was approximately 7 months including: 1 day of screening and vaccination, a total of 5 vaccine injections over a 28-day period, 1 safety-follow up visit at Day 42, 1 safety follow-up/end of study visit at Day 56 and a 6-month safety follow-up call after last vaccine administration.
Interventions
BIOLOGICALVRVg-2
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
BIOLOGICALPurified Inactivated Rabies Vaccine
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
BIOLOGICALHuman Diploid Cell Vaccine (HDCV)
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
BIOLOGICALRabies immune globulin (human)
Pharmaceutical form: Solution for injection; Route of administration: IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: the participant (or legally acceptable representative) and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member administered the appropriate vaccine but was not involved in the immunogenicity and safety evaluations.
Intervention model description
The study was divided into 4 groups: groups 1 to 3 (VRVg-2 + HRIG; Verorab + HRIG; Imovax Rabies + HRIG) were modified double-blind and group 4 (VRVg-2 standalone) was open-label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Men or women aged \>=18 years on the day of inclusion (\>= 18 years means from the day of the 18th birthday onwards, with no upper age limit). * Able to attend all scheduled visits and to comply with all trial procedures. * Body Mass Index (BMI): 18.5 kilograms per square meter (kg/m\^2) less than or equal to (\<=) BMI \<=30 kg/m\^2.
Exclusion criteria
* 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. * 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. * Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 7. * Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccines or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * 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). * At high risk for rabies exposure during the trial (veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies was enzootic). * Known systemic hypersensitivity to any of the vaccine or 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. * Self-reported thrombocytopenia, contraindicating IM vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. * Current alcohol or substance abuse that, in the opinion of the investigator, might interfere with the trial conduct of completion. * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \>=38.0 degree Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Personal history of Guillain-Barré syndrome. * 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis | Day 28 | RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Lower limit of quantitation (LLOQ) for the RFFIT assay was 0.2 IU/mL. |
| Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. |
| Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post vaccination (i.e., on Day 14, 28 and Day 42) and pre-vaccination on Day 0. |
| Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported. |
| Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Immune response of VRVg-2 was considered sufficient if the lower limit of the 95% CI for percentage of participants in Group 1 with RVNA titers \>=0.5 IU/mL was not less than 95% at Day 28, when the primary non-inferiority objective was achieved at Day 28. |
| Number of Participants With 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 expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB 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 Solicited Systemic Reactions | Up to 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB 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 Unsolicited Adverse Events | Up to 28 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset post-vaccination. |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7) | An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had 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. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion. |
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes after any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had 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 book (CRB) 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 CRB. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs). |
Countries
France
Participant flow
Recruitment details
The study was conducted at 2 active centers in France.
Pre-assignment details
A total of 640 participants were enrolled in the study. Data presented in the disposition table (all milestones) is based on randomized group, except for safety analysis set (SafAS) milestone which is presented based on the actual vaccination group.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 VRVg-2+HRIG Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) injection at Day 0. | 320 |
| Group 2 Verorab+HRIG Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. | 107 |
| Group 3 Imovax Rabies+HRIG Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0. | 107 |
| Group 4 VRVg-2 Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28. | 106 |
| Total Title | 640 |
| Total | 1,280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 21 | 4 | 10 | 5 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1 VRVg-2+HRIG | Total Title | Group 4 VRVg-2 | Group 3 Imovax Rabies+HRIG | Group 2 Verorab+HRIG |
|---|---|---|---|---|---|
| Age, Continuous | 46.0 years STANDARD_DEVIATION 14.7 | 46.1 years STANDARD_DEVIATION 14.9 | 46.4 years STANDARD_DEVIATION 15 | 46.3 years STANDARD_DEVIATION 15.6 | 46.2 years STANDARD_DEVIATION 14.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 8 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 11 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 301 Participants | 612 Participants | 105 Participants | 104 Participants | 102 Participants |
| Sex: Female, Male Female | 196 Participants | 382 Participants | 60 Participants | 65 Participants | 61 Participants |
| Sex: Female, Male Male | 124 Participants | 258 Participants | 46 Participants | 42 Participants | 46 Participants |
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 | 0 / 320 | 0 / 107 | 0 / 107 | 0 / 104 |
| other Total, other adverse events | 204 / 320 | 59 / 107 | 66 / 107 | 67 / 104 |
| serious Total, serious adverse events | 4 / 320 | 4 / 107 | 0 / 107 | 3 / 104 |
Outcome results
Primary
Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
Time frame: Day 28
Population: Analysis was performed on the per-protocol analysis set (PPAS) that included all participants who received at least 1 dose of the study vaccines. The participants who presented protocol deviations, met PPAS exclusion criteria were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Groups 1, 2, and 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis | 99.6 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis | 100 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis | 98.7 percentage of participants |
95% CI: [-2.33, 4.35]
95% CI: [-1.32, 6.5]
Secondary
Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post vaccination (i.e., on Day 14, 28 and Day 42) and pre-vaccination on Day 0.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 14/Day 0 | 24.0 ratio |
| Group 1 VRVg-2+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 42/Day 0 | 135 ratio |
| Group 1 VRVg-2+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 28/Day 0 | 64.8 ratio |
| Group 2 Verorab+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 14/Day 0 | 18.6 ratio |
| Group 2 Verorab+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 42/Day 0 | 94.7 ratio |
| Group 2 Verorab+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 28/Day 0 | 50.3 ratio |
| Group 3 Imovax Rabies+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 28/Day 0 | 55.1 ratio |
| Group 3 Imovax Rabies+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 14/Day 0 | 18.3 ratio |
| Group 3 Imovax Rabies+HRIG | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 42/Day 0 | 107 ratio |
| Group 4 VRVg-2 | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 14/Day 0 | 53.7 ratio |
| Group 4 VRVg-2 | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 42/Day 0 | 197 ratio |
| Group 4 VRVg-2 | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers | Day 28/Day 0 | 123 ratio |
Secondary
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had 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 book (CRB) 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 CRB. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs).
Time frame: Within 30 minutes after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Population: Analysis was performed on the safety analysis set (SafAS) that included participant who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 2 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 5 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-any vaccination | 3 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 3 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 3 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 4 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 4 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-any vaccination | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 2 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 3 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 5 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 2 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 4 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 3 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 5 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-any vaccination | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 5 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 2 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 1 Participants |
| Group 4 VRVg-2 | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 4 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 3 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Post-any vaccination | 1 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had 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. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.
Time frame: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7)
Population: Analysis was performed on the SafAS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAE | 4 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESI | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAE related to study vaccine | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESI related to study vaccine | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAE related to study vaccine | 2 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAE | 4 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESI related to study vaccine | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESI | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESI related to study vaccine | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAE | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAE related to study vaccine | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESI | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESI | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAE related to study vaccine | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAE | 3 Participants |
| Group 4 VRVg-2 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESI related to study vaccine | 0 Participants |
Secondary
Number of Participants With Solicited Injection Site Reactions
A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB 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 was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 4 | 69 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 5 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 3 | 73 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 142 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 71 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 3 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 2 | 84 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 1 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 2 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 2 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 5 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 2 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 1 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 5 | 40 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 2 | 17 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 1 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 3 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 1 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 37 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 19 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 3 | 14 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 4 | 12 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 5 | 12 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 5 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 1 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 1 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 4 | 29 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 5 | 24 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 3 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 25 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 2 | 17 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 49 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 0 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 3 | 23 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 2 | 20 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 5 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 5 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 3 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 5 | 21 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 4 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 1 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 3 | 23 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 23 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 44 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 4 | 27 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 3 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 4 | 1 Participants |
Secondary
Number of Participants With Solicited Systemic Reactions
SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB 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: Up to 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Population: Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 3 | 2 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 4 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 34 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 5 | 6 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 20 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 2 | 7 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 4 | 8 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 3 | 9 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 2 | 26 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 35 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 4 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 50 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 5 | 2 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 107 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 50 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 44 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 58 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 3 | 38 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 26 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 4 | 29 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 118 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 5 | 23 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 2 | 10 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 5 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 3 | 1 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 13 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 4 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 5 | 1 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 2 | 3 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 7 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 8 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 4 | 1 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 11 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 35 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 4 | 10 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 8 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 3 | 4 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 37 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 3 | 13 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 20 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 5 | 7 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 13 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 17 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 2 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 2 | 5 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 14 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 2 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 4 | 2 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 4 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 3 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 4 | 5 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 5 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 38 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 18 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 2 | 10 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 3 | 16 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 5 | 5 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 14 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 5 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 3 | 4 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 4 | 1 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 5 | 2 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 38 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 23 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 9 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 15 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 10 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 1 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 5 | 2 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 4 | 14 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 3 | 14 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 4 | 17 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 33 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 2 | 6 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 17 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 3 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 20 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 36 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 5 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 14 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 4 | 1 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 5 | 11 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 3 | 6 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 2 | 1 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 4 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 3 | 12 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 4 | 6 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 13 Participants |
| Group 4 VRVg-2 | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 5 | 13 Participants |
Secondary
Number of Participants With Unsolicited Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset post-vaccination.
Time frame: Up to 28 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5)
Population: Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Number of Participants With Unsolicited Adverse Events | Post-any vaccination | 145 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 1 | 47 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 2 | 27 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 3 | 31 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 4 | 37 Participants |
| Group 1 VRVg-2+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 5 | 60 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 5 | 11 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 3 | 9 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Unsolicited Adverse Events | Post-any vaccination | 46 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 2 | 5 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 1 | 22 Participants |
| Group 2 Verorab+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 4 | 9 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 1 | 12 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 2 | 11 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 3 | 7 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 5 | 12 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Unsolicited Adverse Events | Post-vaccination 4 | 14 Participants |
| Group 3 Imovax Rabies+HRIG | Number of Participants With Unsolicited Adverse Events | Post-any vaccination | 39 Participants |
| Group 4 VRVg-2 | Number of Participants With Unsolicited Adverse Events | Post-vaccination 4 | 11 Participants |
| Group 4 VRVg-2 | Number of Participants With Unsolicited Adverse Events | Post-vaccination 5 | 21 Participants |
| Group 4 VRVg-2 | Number of Participants With Unsolicited Adverse Events | Post-vaccination 1 | 10 Participants |
| Group 4 VRVg-2 | Number of Participants With Unsolicited Adverse Events | Post-vaccination 3 | 8 Participants |
| Group 4 VRVg-2 | Number of Participants With Unsolicited Adverse Events | Post-any vaccination | 42 Participants |
| Group 4 VRVg-2 | Number of Participants With Unsolicited Adverse Events | Post-vaccination 2 | 5 Participants |
Secondary
Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0: Complete Neutralization | 0.4 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 42: Complete Neutralization | 100 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 28: Complete Neutralization | 100 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 14: Complete Neutralization | 98.7 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 42: Incomplete Neutralization | 0 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0: Incomplete Neutralization | 99.6 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 28: Incomplete Neutralization | 0 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 14: Incomplete Neutralization | 1.3 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0: Incomplete Neutralization | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 42: Incomplete Neutralization | 0 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 28: Complete Neutralization | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0: Complete Neutralization | 0 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 14: Incomplete Neutralization | 0 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 28: Incomplete Neutralization | 0 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 14: Complete Neutralization | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 42: Complete Neutralization | 100 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0: Complete Neutralization | 0 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0: Incomplete Neutralization | 100 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 14: Complete Neutralization | 98.7 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 14: Incomplete Neutralization | 1.3 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 28: Complete Neutralization | 98.7 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 28: Incomplete Neutralization | 1.3 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 42: Complete Neutralization | 100 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 42: Incomplete Neutralization | 0 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0: Incomplete Neutralization | 98.6 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 42: Complete Neutralization | 100 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 28: Incomplete Neutralization | 0 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 42: Incomplete Neutralization | 0 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 14: Incomplete Neutralization | 1.3 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 0: Complete Neutralization | 1.4 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 28: Complete Neutralization | 100 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization | Day 14: Complete Neutralization | 98.7 percentage of participants |
Secondary
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
RVNA titer against rabies virus was assessed using the RFFIT assay method. Lower limit of quantitation (LLOQ) for the RFFIT assay was 0.2 IU/mL.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 14 | 99.5 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 0 | 0 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 28 | 100 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 42 | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 42 | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 28 | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 0 | 0 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 14 | 100 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 28 | 98.7 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 14 | 98.5 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 42 | 100 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 0 | 0 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 14 | 100 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 42 | 100 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 0 | 0 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) | Day 28 | 100 percentage of participants |
Secondary
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method. Immune response of VRVg-2 was considered sufficient if the lower limit of the 95% CI for percentage of participants in Group 1 with RVNA titers \>=0.5 IU/mL was not less than 95% at Day 28, when the primary non-inferiority objective was achieved at Day 28.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 28 | 99.6 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 0 | 0 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 14 | 92.5 percentage of participants |
| Group 1 VRVg-2+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 42 | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 42 | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 28 | 100 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 0 | 0 percentage of participants |
| Group 2 Verorab+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 14 | 88.0 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 14 | 94.1 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 0 | 0 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 28 | 98.7 percentage of participants |
| Group 3 Imovax Rabies+HRIG | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 42 | 98.7 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 14 | 97.1 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 0 | 0 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 42 | 100 percentage of participants |
| Group 4 VRVg-2 | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL | Day 28 | 100 percentage of participants |
Secondary
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
Time frame: Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 VRVg-2+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 42 | 13.6 IU/mL |
| Group 1 VRVg-2+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 28 | 6.49 IU/mL |
| Group 1 VRVg-2+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 0 | 0.100 IU/mL |
| Group 1 VRVg-2+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 14 | 2.40 IU/mL |
| Group 2 Verorab+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 0 | 0.100 IU/mL |
| Group 2 Verorab+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 42 | 9.47 IU/mL |
| Group 2 Verorab+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 28 | 5.03 IU/mL |
| Group 2 Verorab+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 14 | 1.86 IU/mL |
| Group 3 Imovax Rabies+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 42 | 10.7 IU/mL |
| Group 3 Imovax Rabies+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 0 | 0.100 IU/mL |
| Group 3 Imovax Rabies+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 14 | 1.83 IU/mL |
| Group 3 Imovax Rabies+HRIG | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 28 | 5.51 IU/mL |
| Group 4 VRVg-2 | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 28 | 12.4 IU/mL |
| Group 4 VRVg-2 | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 14 | 5.41 IU/mL |
| Group 4 VRVg-2 | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 42 | 19.8 IU/mL |
| Group 4 VRVg-2 | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus | Day 0 | 0.101 IU/mL |