| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 28 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00099.6(97.7 to 100)
- OG001100(95.3 to 100)
- OG00298.7(93.1 to 100)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Difference in Percentage | -0.42 | | | 2-Sided | 95 | -2.33 | 4.35 | | | | | Non-Inferiority | The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 2) was greater than (>) -5% at Day 28. | | |
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| 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. | Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| 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. | Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Group 4 VRVg-2 |
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| 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. | Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| 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. | Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 0 (pre-vaccination), Day 14, Day 28 and Day 42 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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). | 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. | Posted | | Count of Participants | | Participants | | Within 30 minutes after any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Group 2 Verorab+HRIG | |
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| 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. | Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | Within 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3 Imovax Rabies+HRIG | |
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| 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. | Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | Up to 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | Up to 28 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | Analysis was performed on the SafAS. | Posted | | Count of Participants | | Participants | | From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Group 2 Verorab+HRIG | |
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