Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03145766 | Immunogenicity and Safety of a Purified Vero Rabies Vaccine | PHASE2 | COMPLETED | 320 | — | — | Apr 17, 2017 | Jan 8, 2018 | Apr 19, 2022 | 5 | United States |
RVNA GMT against rabies virus was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
RVNA GMT against rabies virus was assessed using the RFFIT assay method.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>=0.2 IU/mL were considered as seropositive.
RVNA titer against rabies virus was assessed using the RFFIT assay method. Participants with RVNA titer \>= 0.2 IU/mL were considered as seropositive.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| VRVg 2 | BIOLOGICAL | Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free |
| 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 |
| Human Rabies Immunoglobulins (HRIG) | BIOLOGICAL | Commercialized formulation of HRIG |
Inclusion Criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: 1. Aged 18 to less than 65 years on the day of inclusion. 2. Informed consent form had been signed and dated. 3. Able to attend all scheduled visits and to complied with all t...