Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1227-4143 | Registry Identifier | ICTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses [2-2-2]) and Day 42 (to assess the immune response after 4 doses [2-2-2-0-2]) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults.
Secondary Objectives:
The duration of each participant's participation in the study is approximately 7 months (28 day-vaccination period followed by 6 month safety follow-up period).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: pediatric participants; VRVg-2 | Experimental | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 |
|
| Group 2: pediatric participants; Verorab | Active Comparator | Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 |
|
| Group 3: adult participants; VRVG-2 + ERIG | Experimental | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 + ERIG at D0 |
|
| Group 4: adult participants; Verorab + ERIG | Active Comparator | Verorab 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 + ERIG at D0 |
|
| Group 5: adult participants; VRVG-2 + HRIG | Experimental | VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 + HRIG at D0 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purified vero rabies vaccine - serum free VRVg-2 | Biological | Pharmaceutical form:freeze-dried Route of administration: intradermal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL | RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT) | Day 14 (post-vaccination) |
| Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL | RVNA titers will be measured by RFFIT | Day 42 (post-vaccination) |
| Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification | RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL | Day 14 (post-vaccination) |
| Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification | RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL | Day 42 (post-vaccination) |
| Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants | RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated | Day 14 (post-vaccination) |
| Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants | RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 42 RVNA ratios Day42/Day0 will be calculated |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting immediate adverse events (AEs) | Includes unsolicited (spontaneously reported) systemic AEs | Within 30 minutes post-vaccination |
| Percentage of participants reporting solicited injection site reactions |
Not provided
Inclusion Criteria:
Inclusion criteria :
The following criterion only applies to healthy adults ≥ 18 years:
- Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2
Exclusion Criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :7640004 | Bangkok | 10400 | Thailand | |||
| Investigational Site Number :7640002 |
Not provided
| Label | URL |
|---|---|
| VRV09 Plain Language Results Summary | View source |
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
Not provided
Not provided
Not provided
Not provided
Modified double-blind: the participant (or legally acceptable representative) and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will prepare and administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
|
| Group 6: adult participants; Verorab + HRIG | Active Comparator | Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 + HRIG at D0 |
|
| Purified inactivated rabies vaccine | Biological | Pharmaceutical form:freeze-dried Route of administration: intradermal |
|
|
| Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4) | Biological | Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular |
|
|
| Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6) | Biological | Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular |
|
|
| Day 42 (post-vaccination) |
Solicited injection site reactions:
| Within 7 days post-vaccination |
| Percentage of participants reporting solicited systemic reactions | Solicited systemic reactions:
| Between Day 0 and Day 3, between Day 3 and Day 7, and during the 7 days following the remaining vaccinations |
| Number of participants reporting unsolicited injection site AEs | Unsolicited (spontaneously reported) injection site AEs | Within 28 days post-vaccination |
| Number of participants reporting unsolicited systemic AEs | Unsolicited (spontaneously reported) systemic AEs | Between each vaccination and up to 28 days after the last vaccination |
| Number of participants reporting serious adverse events (SAEs) | SAEs, including adverse event of special interest (AESIs) | Up to 6 months post-vaccination |
| Percentage of participants in Group 3 and Group 4 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL | RVNA titers will be measured by RFFIT | Day 14 (post-vaccination) |
| Number of Participants in Group 3 and Group 4 achieving RVNA titer greater than or equal to (≥) lower limit of quantification | RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL | Day 14 (post-vaccination) |
| Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 3 and Group 4 Participants | RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated | Day 14 (post-vaccination) |
| Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL | RVNA titers will be measured by RFFIT | Day 90 (post-vaccination) |
| Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification | RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL | Day 90 (post-vaccination) |
| Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants | RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 RVNA ratios Day90/Day0 will be calculated | Day 90 (post-vaccination) |
| Bangkok |
| Thailand |
| Investigational Site Number :7640003 | Khon Kaen | 40002 | Thailand |
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided