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| Name | Class |
|---|---|
| Vabiotech | INDUSTRY |
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Randomized, open-label, prospective, before-and-after comparison study in the same group.
Subjects suitable for the study will be randomly assigned at a ratio of 1:1 (block 4) to use the study vaccine by one of two routes of administration: Intramuscular or Intramuscular. Previously-unvaccinated subjects receive three injections of vaccine on day 0, 7 and 21-28. The aim of the study is to evaluate the safety and immunogenicity of the inactivated rabies vaccine RABIVAX-S administered intramuscularly and intradermally according to a 3-dose regimen in healthy volunteers.
1 ml dose vaccine containing ≥ 2.5 IU of purified rabies antigen (Pitman-Moore rabies virus strain 3218; acclimatized and cultured on vero cells, inactivated with β propiolactone).
Pre-exposure prophylaxis regimens for two groups
Randomization was performed according to two age stratifications:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety of a 3-dose regimen of RABIVAX-S in healthy participants aged 5 to 60 years | Experimental | RABIVAX-S is a pure, sterile inactivated rabies vaccine produced on vero cells. RABIVAX-S vaccine is lyophilized and is supplied with rehydration solution (1 vial containing 1 dose of lyophilized vaccine and 1 vial of rehydration solution). |
|
| immunogenicityof a 3-dose regimen of RABIVAX-S in subgroup of participants | Experimental | RABIVAX-S is a pure, sterile inactivated rabies vaccine produced on vero cells. RABIVAX-S vaccine is lyophilized and is supplied with rehydration solution (1 vial containing 1 dose of lyophilized vaccine and 1 vial of rehydration solution). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RABIVAX-S | Biological | 1 ml dose vaccine containing ≥ 2.5 IU of purified rabies antigen (Pitman-Moore rabies virus strain 3218; acclimatized and cultured on vero cells, inactivated with β propiolactone). Pre-exposure prophylaxis regimens for two groups
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE) after | Solicited local and systemic AEs were assessed by study staff in 30 minutes after vaccination. | Within 30 minutes of each vaccination |
| Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE) | Solicited local AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days | within 7 days (day 1 to 7) of each vaccination and within 21 day after the first vaccination |
| Rate of Subjects Experiencing Unsolicited Adverse Events (AE) | Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE | during 21 days after the third vaccination |
| Rate of Subjects Experiencing Unsolicited Serious Adverse Events (SAE) | A serious adverse event (SAE) is defined as an AE that meets one of the following conditions: Deadly. Life-threatening. Requires inpatient hospital admission or extended stay in hospital. Causes birth defects. Causes permanent or permanent injury or disability. Critical medical events that may not be fatal, not life-threatening, or require inpatient treatment will be considered a SAE if it is judged by professional judgment that the incident would be potentially dangerous. subject's health and the need for medical or surgical intervention to prevent one of the aforementioned consequences | Day 1 to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Subjects With Seroconversion of rabies virus neutralizing antibody (RVNA) for Vaccine Antigens for subgroup of subjects | Serum specimens were tested for the presence and titer of rabies virus neutralizing antibody (RVNA) and the seroprotection rate was RVNA titer ≥0.5 IU/mL | Day 0, day 7, day 21 and day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pham N Hung, As. Prof. | Vietnam Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CDC Thai Binh | Thái Bình | 410000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39927222 | Derived | Hung PN, Giang LTH, Anh NT, Anh BDT, Pho DC, Van Hung P. Safety and immunogenicity of an inactivated vero cell-based rabies vaccine (Rabivax-S) in pre-exposure prophylaxis schedule in Vietnam. Clin Exp Vaccine Res. 2025 Jan;14(1):51-58. doi: 10.7774/cevr.2025.14.e9. Epub 2025 Jan 22. |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Geometric Mean Titer (GMT) of rabies virus neutralizing antibody (RVNA) for Vaccine Antigens at Baseline and Day 22 or 49 after vaccination (depending on age group) for each antigenic component of the vaccine |
Serum specimens during Phase 3 were tested for the presence and titer of RVNA |
| Day 0, day 7, day 21 and day 42 |
| D007239 | Infections |