| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) After a Booster Dose of Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine | A SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required/prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the participants or may require intervention to prevent one of the other outcomes listed. Safety is assessed as the number of participants reporting SAEs after a booster dose of PCEC rabies vaccine administered in this extension study, if RNVA concentrations were <0.5 IU/mL, following a primary series of accelerated or conventional rabies pre-exposure (PrEP) intramuscular (IM) regimen in the parent study. | The analysis was performed on the Safety Set which included all enrolled participants who received a booster dose and reported safety data. | Posted | | Count of Participants | | Participants | | From booster vaccination [6 to 9 months after Year 3 (3 years after primary series of vaccination)] up until completion of the safety follow-up period (10 years after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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| Primary | Number of Participants Who Had Their Rabies Virus Neutralizing Antibody (RNVA) Concentrations Drop Below 0.5 International Units (IU) Per Milliliter (mL) Between Day 366 and Year 3 | | The analysis was performed on the Full Analysis Set-2 (FAS-2): long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Count of Participants | | Participants | | Day 366 to Year 3 (after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group |
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| Primary | Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 3 and Year 4 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Count of Participants | | Participants | | Year 3 to Year 4 (after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | |
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| Primary | Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 4 and Year 5 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Count of Participants | | Participants | | Year 4 to Year 5 (after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | |
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| Primary | Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 5 and Year 6 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Count of Participants | | Participants | | Year 5 to Year 6 (after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | |
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| Primary | Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 6 and Year 7 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Count of Participants | | Participants | | Year 6 to Year 7 (after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | |
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| Primary | Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 7 and Year 8 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Count of Participants | | Participants | | Year 7 to Year 8 (after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | |
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| Primary | Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 8 and Year 9 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Count of Participants | | Participants | | Year 8 to Year 9 (after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | |
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| Primary | Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 9 and Year 10 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Count of Participants | | Participants | | Year 9 to Year 10 (after primary series of vaccination) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | |
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| Primary | RVNA Antibody Concentrations 7 Days After the Booster Dose | RVNA antibody concentrations were measured in terms of Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations <0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9. | Analysis was performed on the Full Analysis Set-1 (FAS-1): booster immunogenicity analysis, which included all eligible participants from the V49_23 study enrolled in this extension study, whom received booster dose (booster dose was administered only when participants reached RVNA concentrations <0.5 IU/mL) and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Day 7 after booster dose | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group |
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| Primary | RVNA Geometric Mean Ratios (GMRs) 7 Days After the Booster Dose Versus Antibody Concentrations Before the Booster Dose | GMR was calculated as ratio of post booster dose RVNA GMCs (7-day post booster dose) to the baseline RVNA GMCs (7 days before booster dose). The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations <0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9. | Analysis was performed on the FAS-1: booster immunogenicity analysis, which included all eligible participants from the V49_23 study enrolled in this extension study, whom received booster dose (booster dose was administered only when participants reached RVNA concentrations <0.5 IU/mL) and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Day 7 after booster dose compared to baseline (7 days before booster dose) | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | |
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| Primary | Percentage of Participants With RVNA Concentrations Greater Than or Equal to (>=) 0.5 IU/mL, 7 Days After Booster Dose | The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations <0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9. | Analysis was performed on the FAS-1: booster immunogenicity analysis, which included all eligible participants from the V49_23 study enrolled in this extension study, whom received booster dose (booster dose was administered only when participants reached RVNA concentrations <0.5 IU/mL) and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Day 7 after booster dose | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | |
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| Primary | Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 3 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Year 3 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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| Primary | Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 4 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Year 4 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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| Primary | Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 5 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Year 5 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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| Primary | Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 6 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Year 6 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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| Primary | Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 7 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Year 7 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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| Primary | Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 8 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Year 8 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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| Primary | Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 9 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Year 9 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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| Primary | Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 10 | | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Year 10 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 | Conv-R Group | |
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| Secondary | Rabies Virus Neutralizing Antibody Concentrations | Antibody concentrations were measured in terms of GMCs and expressed in IU/mL. | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoints. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. | | OG002 |
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| Secondary | Reverse Cumulative Percentage for Participants With RVNA Concentrations >=0.5 IU/mL | As specified in the statistical analysis plan, a graphical presentation of the Reverse Cumulative Distribution Plots for participants with RVNA concentrations >=0.5 IU/mL was analyzed for this outcome measure. Due to system constrains, only the reverse cumulative percentage values were reported, to depict the Reverse Cumulative Distribution Plots. | The analysis was performed on the FAS-2: long term immunogenicity analysis which included all eligible participants from the V49_23 study enrolled in this extension study and provided immunogenicity data for the specific analysis at the specific timepoints. | Posted | | Number | | Cumulative percentage of participants | | At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration | | | | ID | Title | Description |
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| OG000 | Conv-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (<)0.5 IU/mL at scheduled visits. | | OG001 | Acc-R/JE Group | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were <0.5 IU/mL at scheduled visits. |
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