Rabies
Conditions
Brief summary
The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out successively according to the age of the subjects from the oldest to the youngest. The first 40 subjects aged 18-60 were randomly assigned to the Essen experimental group and the Zagreb experimental group in a 1:1 ratio, all of whom received the experimental vaccine. After the observation of the third dose of vaccine for at least 7 days, the preliminary safety assessment was conducted. If the incidence of grade 3 or higher adverse events associated with the experimental vaccination did not exceed 15%, and no vaccination-related death or life-threatening serious adverse events occurred, 40 subjects aged 10-17 years old were enrolled, and 40 subjects aged 10-17 years old were randomly assigned to the Essen and Zagreb trials in a 1:1 ratio. Conduct safety studies. Safety study: All adverse events that occurred within 30 minutes, 0-7 days, and 0-30 days after each dose were collected, as well as all serious adverse events that occurred within 6 months after the first dose. Blood and urine samples were collected before the first dose and 3 days after the first dose, and blood routine, blood biochemical and urine routine tests were performed for safety assessment.
Interventions
This vaccine（1.0ml） is produced by Ab&b Biotechnology Co., Ltd.JS. Subjects will receive the Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried vaccinated by intramuscular injection.
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Ab&B Bio-tech Co., Ltd.JS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age at enrollment ranged from 10 to 60 years； * Subjects/subjects and their guardians voluntarily agreed to participate in the study and signed an informed consent form; * Participants and their families are permitted to participate in study follow-up visits as required by the protocol (no long-term departure or family relocation plan)； * Female subjects were non-pregnant or lactating (negative urine pregnancy test before vaccination) and had no plans to get pregnant within 2 months after enrollment； * The axillary temperature was \< 37.3 ° C.
Exclusion criteria
a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of adverse events/reactions within 1 month from the first dose to full immunization; | Within 1 month from the first dose to full immunization | The occurrence of adverse events/reactions within 1 month from the first dose to full immunization; |
| The occurrence of serious adverse events/reactions within 6 month from the first dose to full immunization; | Within 6 month from the first dose to full immunization | The occurrence of serious adverse events/reactions within 6 month from the first dose to full immunization; |
| The abnormal occurrence of laboratory indicators (blood biochemistry, blood routine and urine routine) 3 days after the first dose of vaccination | 3 days after the first dose | The abnormal occurrence of laboratory indicators (blood biochemistry, blood routine and urine routine) 3 days after the first dose of vaccination |
Countries
China
Outcome results
None listed