Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1174-4976 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.
This study assessed different formulations of the modified formulation of VRVg (VRVg 2- formulations 1 [low], 2 [medium] and 3 [high]) tested in parallel to the initial VRVg formulation (VRVg-1) and Imovax Rabies. Immune responses were assessed at Day 14, Day 28, Day 42, and at Month 7. Safety events were also reported.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | Experimental | VRVg-2 formulation 1, intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0. |
|
| Group 2: VRVg-2 Formulation 2 | Experimental | VRVg-2 formulation 2, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
|
| Group 3: VRVg-2 Formulation 3 | Experimental | VRVg-2 formulation 3, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
|
| Group 4: VRVg-1 | Experimental | VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
|
| Group 5: Imovax Rabies | Active Comparator | Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRVg 2 | Biological | Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 | RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method. | Day 0 |
| Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. | Day 14 |
| Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. | Day 28 |
| Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. | Day 42 |
| Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. | Month 7 |
| Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >=0.2 IU/mL were considered as seropositive. | Day 0 |
| Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 |
Not provided
Not provided
Inclusion Criteria:
An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
Exclusion Criteria:
An individual fulfilling any of the following criteria was to be excluded from trial enrollment:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Redding | California | 96001 | United States | ||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37921410 | Derived | Pichon S, Guinet-Morlot F, Saleh J, Essink B, Pineda-Pena AC, Moureau A, Petit C, Minutello AM. Safety and immunogenicity of three dose levels of an investigational, highly purified Vero cell rabies vaccine: A randomized, controlled, observer-blinded, Phase II study with a simulated post-exposure regimen in healthy adults. Hum Vaccin Immunother. 2023 Dec 15;19(3):2275453. doi: 10.1080/21645515.2023.2275453. Epub 2023 Nov 3. |
Not provided
Not provided
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
A total of 320 participants were enrolled and vaccinated in the study.
The study was conducted at 5 centers in the United States from 17 April 2017 to 08 January 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: VRVg-2 Formulation 1 | VRVg-2 formulation 1 (Low), intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0. |
| FG001 | Group 2:VRVg-2 Formulation 2 | VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| FG002 | Group 3: VRVg-2 Formulation 3 | VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| FG003 | Group 4: VRVg-1 | VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| FG004 | Group 5: Imovax Rabies | Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Active Vaccination Phase (Day 0-Day 56) |
|
| |||||||||||||||||||||||||||||||||
| Follow-up Phase (Day 56 Till Month 7) |
|
Analysis was performed on all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: VRVg-2 Formulation 1 | VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| BG001 | Group 2:VRVg-2 Formulation 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 | RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method. | Per-Protocol Analysis Set (PPAS): participants who received at least one dose of the study vaccine without protocol deviations before Day 14 (i.e., 7 days after the 3rd vaccine injection). | Posted | Geometric Mean | 95% Confidence Interval | international units per milliliter | Day 0 |
|
AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: VRVg-2 Formulation 1 | VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Paralysis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Bruise | General disorders | MedDRA 19.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 1# | Contact-US@sanofi.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2017 | Jan 5, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2017 | Jan 5, 2021 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| VRVg 1 | Biological | Initial formulation of Purified Vero Rabies Vaccine Serum Free |
|
| Imovax Rabies | Biological | Purified inactivated rabies vaccine prepared on human diploid cell cultures |
|
| VRVg 2 | Biological | Modified formulation 2 (Medium) of Purified Vero Rabies Vaccine Serum Free |
|
| VRVg 2 | Biological | Modified formulation 3 (High) of Purified Vero Rabies Vaccine Serum Free |
|
| Human Rabies Immunoglobulins (HRIG) | Biological | Commercialized formulation of HRIG |
|
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >=0.2 IU/mL were considered as seropositive. |
| Day 14 |
| Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >=0.2 IU/mL were considered as seropositive. | Day 28 |
| Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >=0.2 IU/mL were considered as seropositive. | Day 42 |
| Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >= 0.2 IU/mL were considered as seropositive. | Month 7 |
| Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 7 days post 3rd vaccination (i.e., on Day 14) and pre-vaccination on Day 0. | Day 0 (pre-dose) and Day 14 (7 days post-dose 3) |
| Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 4th vaccination (i.e., on Day 28) and pre-vaccination on Day 0. | Day 0 (pre-dose) and Day 28 (14 days post-dose 4) |
| Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 5th vaccination (i.e., on Day 42) and pre-vaccination on Day 0. | Day 0 (Pre-dose) and Day 42 (14 days Post-dose 5) |
| Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 6 month post last vaccination on Month 7 and pre-vaccination on Day 0. | Day 0 (Pre-dose) and Month 7 (6 Months Post Last Vaccination) |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Day 0 |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Day 14 |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Day 28 |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Day 42 |
| Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Month 7 |
| Number of Participants With Immediate Unsolicited Adverse Events | An adverse event was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs). | Within 30 Minutes After any Vaccination |
| Number of Participants With at Least One Solicited Injection Site Reactions | A solicited reaction (SR) was an AR observed and reported under conditions (symptoms and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain, erythema and swelling at and around the injection site. | Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5) |
| Number of Participants With at Least One Solicited Systemic Reactions | A solicited reaction was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, headache, malaise and myalgia. | Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5) |
| Number of Participants With at Least One Unsolicited Adverse Events | An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. | Within 28 Days After any vaccination |
| Number of Participants With Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event. | From Day 0 up to Month 7 |
| San Diego |
| California |
| 92117 |
| United States |
| Investigational Site | South Miami | Florida | 33143 | United States |
| Investigational Site | Omaha | Nebraska | 68134 | United States |
| Investigational Site | Las Vegas | Nevada | 89104 | United States |
| Non-compliance with the Protocol |
|
| Lost to Follow-up |
|
| Voluntary Withdrawal Not Due AE |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
| BG002 | Group 3: VRVg-2 Formulation 3 | VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| BG003 | Group 4: VRVg-1 | VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| BG004 | Group 5: Imovax Rabies | Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| OG002 | Group 3: VRVg-2 Formulation 3 | VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| OG003 | Group 4: VRVg-1 | VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
| OG004 | Group 5: Imovax Rabies | Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. |
|
|
| Primary | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. | Analysis was performed on PPAS. | Posted | Geometric Mean | 95% Confidence Interval | international units per milliliter | Day 14 |
|
|
|
| Primary | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | international units per milliliter | Day 28 |
|
|
|
| Primary | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | international units per milliliter | Day 42 |
|
|
|
| Primary | Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 | RVNA GMT against rabies virus was assessed using the RFFIT assay method. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | international units per milliliter | Month 7 |
|
|
|
| Primary | Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >=0.2 IU/mL were considered as seropositive. | Analysis was performed on PPAS. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 |
|
|
|
| Primary | Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >=0.2 IU/mL were considered as seropositive. | Analysis was performed on PPAS. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 14 |
|
|
|
| Primary | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >=0.2 IU/mL were considered as seropositive. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 |
|
|
|
| Primary | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >=0.2 IU/mL were considered as seropositive. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 42 |
|
|
|
| Primary | Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 | RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer >= 0.2 IU/mL were considered as seropositive. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 7 |
|
|
|
| Primary | Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 7 days post 3rd vaccination (i.e., on Day 14) and pre-vaccination on Day 0. | Analysis was performed on PPAS. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (pre-dose) and Day 14 (7 days post-dose 3) |
|
|
|
| Primary | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 4th vaccination (i.e., on Day 28) and pre-vaccination on Day 0. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (pre-dose) and Day 28 (14 days post-dose 4) |
|
|
|
| Primary | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 14 days post 5th vaccination (i.e., on Day 42) and pre-vaccination on Day 0. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (Pre-dose) and Day 42 (14 days Post-dose 5) |
|
|
|
| Primary | Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) | RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs 6 month post last vaccination on Month 7 and pre-vaccination on Day 0. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (Pre-dose) and Month 7 (6 Months Post Last Vaccination) |
|
|
|
| Primary | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 |
|
|
|
| Primary | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Analysis was performed on PPAS. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 14 |
|
|
|
| Primary | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 |
|
|
|
| Primary | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 42 |
|
|
|
| Primary | Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 | Complete virus neutralization was defined as absence of fluorescent cells at the participant/time point level at the starting dilution (1/5) of the RFFIT assay. Percentage of participants with complete virus neutralization were reported. | Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 7 |
|
|
|
| Primary | Number of Participants With Immediate Unsolicited Adverse Events | An adverse event was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Immediate AEs considered as related to vaccination were recorded as immediate unsolicited adverse reactions (ARs). | Analysis was performed on safety analysis set (SafAS) that included participant who had received at least one least one dose of the study vaccine and were analyzed according to the actual treatment received. 1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. | Posted | Count of Participants | Participants | Within 30 Minutes After any Vaccination |
|
|
|
| Primary | Number of Participants With at Least One Solicited Injection Site Reactions | A solicited reaction (SR) was an AR observed and reported under conditions (symptoms and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain, erythema and swelling at and around the injection site. | Analysis performed on SafAS. Here, 'number analyzed' = participants with available data for each specified category.1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. At Vaccination 2, 1 participant of Group 1 received Group 2 vaccine and thus counted in Group 2 for post-vaccination 2 safety analysis. | Posted | Count of Participants | Participants | Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5) |
|
|
|
| Primary | Number of Participants With at Least One Solicited Systemic Reactions | A solicited reaction was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, headache, malaise and myalgia. | Analysis performed on SafAS. Here, 'number analyzed' = participants with available data for each specified category.1 participant of Group 4 received Imovax Rabies, and thus counted in Group 5 for safety analysis. At Vaccination 2, 1 participant of Group 1 received Group 2 vaccine and thus counted in Group 2 for post-vaccination 2 safety analysis. | Posted | Count of Participants | Participants | Within 7 Days After any and each vaccination (Vaccination 1, 2, 3, 4 and 5) |
|
|
|
| Primary | Number of Participants With at Least One Unsolicited Adverse Events | An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. | Analysis was performed on SafAS. 1 participant of Group 4 received Imovax Rabies vaccine, and thus counted in Group 5 for safety analysis. | Posted | Count of Participants | Participants | Within 28 Days After any vaccination |
|
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event. | Analysis was performed on SafAS. 1 participant of Group 4 received Imovax Rabies vaccine, and thus counted in Group 5 for safety analysis. | Posted | Count of Participants | Participants | From Day 0 up to Month 7 |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 40 |
| 80 |
| EG001 | Group 2: VRVg-2 Formulation 2 | VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 0 | 80 | 0 | 80 | 39 | 80 |
| EG002 | Group 3: VRVg-2 Formulation 3 | VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 0 | 80 | 1 | 80 | 45 | 80 |
| EG003 | Group 4: VRVg-1 | VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 0 | 39 | 0 | 39 | 22 | 39 |
| EG004 | Group 5: Imovax Rabies | Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. | 0 | 41 | 0 | 41 | 28 | 41 |
| Injection Site Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment | Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE. |
|
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| RVNA titer >= 0.5 IU/mL |
|
| RVNA titer >= 0.5 IU/mL |
|
| RVNA titers >= 0.5 IU/mL |
|
| RVNA titers >= 0.5 IU/mL |
|
| RVNA titers >= 0.5 IU/mL |
|
| Immediate Unsolicited AR |
|
|
| Pain Post-vaccination 1 |
|
|
| Pain Post-vaccination 2 |
|
|
| Pain Post-vaccination 3 |
|
|
| Pain Post-vaccination 4 |
|
|
| Pain Post-vaccination 5 |
|
|
| Erythema post-any vaccination |
|
|
| Erythema Post-vaccination 1 |
|
|
| Erythema Post-vaccination 2 |
|
|
| Erythema Post-vaccination 3 |
|
|
| Erythema Post-vaccination 4 |
|
|
| Erythema Post-vaccination 5 |
|
|
| Swelling post-any vaccination |
|
|
| Swelling Post-vaccination 1 |
|
|
| Swelling Post-vaccination 2 |
|
|
| Swelling Post-vaccination 3 |
|
|
| Swelling Post-vaccination 4 |
|
|
| Swelling Post-vaccination 5 |
|
|
|
| Fever Post-vaccination 1 |
|
|
| Fever Post-vaccination 2 |
|
|
| Fever Post-vaccination 3 |
|
|
| Fever Post-vaccination 4 |
|
|
| Fever Post-vaccination 5 |
|
|
| Headache Post-any Vaccination |
|
|
| Headache Post-vaccination 1 |
|
|
| Headache Post-vaccination 2 |
|
|
| Headache Post-vaccination 3 |
|
|
| Headache Post-vaccination 4 |
|
|
| Headache Post-vaccination 5 |
|
|
| Malaise Post-any Vaccination |
|
|
| Malaise Post-vaccination 1 |
|
|
| Malaise Post-vaccination 2 |
|
|
| Malaise Post-vaccination 3 |
|
|
| Malaise Post-vaccination 4 |
|
|
| Malaise Post-vaccination 5 |
|
|
| Myalgia Post-any Vaccination |
|
|
| Myalgia Post-vaccination 1 |
|
|
| Myalgia Post-vaccination 2 |
|
|
| Myalgia Post-vaccination 3 |
|
|
| Myalgia Post-vaccination 4 |
|
|
| Myalgia Post-vaccination 5 |
|
|