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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-7340 | Other Identifier | WHO | |
| PHRR130822-000107 | Registry Identifier | The Philippine Health Research Registry (PHRR) |
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The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years.
Primary Objectives:
Secondary Objectives:
Participants will receive a total of three vaccinations, one each at Day 0, Day 7, and Day 28, respectively, and will be assessment for immune response to rabies vaccine before the first injection (baseline titer), at Day 42, and at Month 6.
Safety will be assessed in all participants up to 28 days after each injection. Serious adverse events and adverse events of special interest (AESIs) will be collected up to 6 months after the last injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRVg Group | Experimental | Participants will receive receive 3 vaccinations of Purified Vero Rabies Vaccine Serum Free (VRVg) |
|
| Imovax® Rabies Group | Active Comparator | Participants will receive receive 3 vaccinations of Human Diploid Cell Vaccine (HDCV), Imovax® Rabies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purified Vero Rabies Vaccine Serum Free (VRVg) | Biological | 0.5 mL, Intramuscular (Day 0, Day 7 and Day 28). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Subjects with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test (RFFIT) | Rabies virus neutralizing antibody will be measured by rapid fluorescent focus inhibition test (RFFIT) | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial | Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever (temperature), headache, malaise, and myalgia | Day 0 up to 6 months post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Muntinlupa | 1781 | Philippines | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35906106 | Derived | Quiambao B, Montalban C, Minutello AM, Guinet-Morlot F, Moureau A, Petit C, Pichon S. Serum-free purified Vero rabies vaccine is safe and immunogenic in children: Results of a randomized phaseII pre-exposure prophylaxis regimen study. Vaccine. 2022 Aug 19;40(35):5170-5178. doi: 10.1016/j.vaccine.2022.06.061. Epub 2022 Jul 26. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Imovax® Rabies: Human Diploid Cell Vaccine (HDCV), | Biological | 0.5 mL, Intramuscular (Day 0, Day 7 and Day 28). |
|
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| Summary Individual RVNA titer ratio (Day 42/Day 0) following vaccination with either Purified Vero Rabies Vaccine Serum Free (VRVg) or Human Diploid Cell Vaccine, Imovax® Rabies | Rabies virus neutralizing antibody will be measured by rapid fluorescent focus inhibition test (RFFIT) | Day 0 and Day 42 |
| Manila |
| 1000 |
| Philippines |
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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