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 * Intramuscular 1ml on days D0, D7 and D21-28 * Intradermal injection 0.1 ml on days D0, D7 and D21-28 Randomization was performed according to two age stratifications: * Stratification of research subjects from 5-15 years old * Stratification of research subjects from 16-60 years old Population selected research subjects in the community in Dong Hung district, Thai Binh province
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
220
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 * Intramuscular 1ml on days D0, D7 and D21+7 * Intradermal injection 0.1 ml on days D0, D7 and D21+7 Blood samples were collected on days D0, D7 and D21 - 28
CDC Thai Binh
Thái Bình, Vietnam
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 42
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
Time frame: Day 0, day 7, day 21 and day 42
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
Time frame: Day 0, day 7, day 21 and day 42
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