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This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design.
The first stage: According to the order of two age groups of 18-60 years old and 10-17 years old, 40 cases were enrolled in each age group (20 persons for the 5-dose program and 20 for the 4-dose program). Subjects in the 5-dose group received 1 dose of test vaccine on 0, 3, 7, 14, and 28 days each. Subjects in the 4-dose group received 1 dose each on both arms on day 0, and 1 dose on day 7 and day 21 each. All subjects in the first stage were only observed for safety and were followed up to 6 months after the entire course of vaccination.
The second stage: the total number of enrolled 2400 cases, 10-60 years old, the 4-dose program group and the 5-dose program group of the test vaccine, the 4-dose program group and the 5-dose program group of the control vaccine according to the random ratio 1:1:1:1. Among the total number of participants, 1680 cases (420 cases per group) were simultaneously observed for immunogenicity and safety, and the remaining 720 subjects (180 cases per group) only underwent safety observation. 800 subjects (200 cases in each group) received 6-month immune persistence observation after full vaccination, and 400 subjects in the test vaccine group received 12 months immune persistence observation after full vaccination.
In the second stage, 1680 subjects were collected before the immunization, 7 days after the first dose, 14 days after the first dose, and 14 days after the full vaccination to test rabies virus antibodies to evaluate the immunogenicity of the test vaccine. 800 subjects were in the whole process Immune persistent blood sampling was performed 6 months after vaccination, and subjects in the test vaccine group were further subjected to immune persistent blood sampling 12 months after the full course of vaccination to evaluate immune durability. Collect all AEs within 30 minutes after each dose, AEs from 0-7 days, all non-collective AEs from the first dose to 30 days after the full course of vaccination, and all serious AEs from the first dose to 6 months after the full course of vaccination Adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Vaccine - 5-dose program | Experimental | Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, with a titer of not less than 2.5IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. |
|
| Investigational Vaccine - 4-dose program | Experimental | Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, with a titer of not less than 2.5IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. |
|
| Control vaccine - 5-dose program | Active Comparator | Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, titer not less than 2.5IU, Liaoning Chengda Biological Co., Ltd. |
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| Control vaccine - 4-dose program | Active Comparator | Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, titer not less than 2.5IU, Liaoning Chengda Biological Co., Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program | Biological | Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody positive conversion rate - Immunogenicity endpoint | Antibody positive conversion rate of the test group and the control group of the pre-immune antibody-negative population | 14 days after the first dose of vaccination |
| Geometric mean concentration - Immunogenicity endpoint | Geometric mean concentration of the test group and the control group of the pre-immune antibody-negative population | 14 days after the first dose of vaccination |
| Incidence of Adverse Events [Safety and Tolerability] | Incidence of Adverse Events | within 30 minutes after each dose of vaccination; the first dose of vaccination to 30 days after the full course of vaccination |
| Incidence of Serious Adverse Events [Safety and Tolerability] | Incidence of Serious Adverse Events | The first dose of vaccination to 6 months after the full course of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody positive conversion rate - Immunogenicity endpoint | Antibody positive conversion rate | 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination |
| Geometric mean concentration - Immunogenicity endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Center for Disease Control and Prevention | Changsha | Hunan | 410005 | China |
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Similar vaccine control
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| Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program | Biological | Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm |
|
| Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program | Biological | Inoculate 1 dose of control vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm |
|
| Freeze-dried human rabies vaccine (Vero cells) Chengda - 4-dose program | Biological | Inoculate 1 dose of control vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm |
|
Geometric mean concentration |
| 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination |