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| Name | Class |
|---|---|
| Henan Center for Disease Control and Prevention | OTHER_GOV |
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To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.
The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 ~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental vaccines and vaccine | Active Comparator | A total of 1956 subjects were randomly divided into three groups at a ratio of 1:1:1, 652 subjects in each group were vaccinated with the test vaccine or the control vaccine on a schedule of 0, 3, 7, 14, 28 days (a total of 5 doses). Blood samples were collected from the subjects for antibody detection on 0, 7/14, 35/42 days, respectively. |
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| experimental vaccines | Active Comparator | An additional group of 652 people received the trial vaccine in a 0 -, 7 -, and 21-day schedule (two first doses for a total of four doses). Blood samples were collected at 0, 7/14 and 35/42 days for antibody detection, and all subjects were systematically observed for safety. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control vaccine | Biological | A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection. |
| Measure | Description | Time Frame |
|---|---|---|
| 1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention | Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site | Every needle 30 days after vaccination |
| 1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention | Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site | Vaccinations 31 days to 180 days |
| 1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention. | Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed | Every needle 30 days after vaccination |
| 1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention. | Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed | Vaccinations 31 days to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| The immunogenicity was tested by immunofluorescence staining | The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml | 5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples |
| The immunogenicity was tested by immunofluorescence staining |
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Inclusion Criteria:
Exclusion Criteria:
First needle exclusion:
Subsequent needle exclusions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xia Shengli | Zhengzhou | Henan | 450000 | China |
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Lyophilized rabies vaccine for human use (Vero cell) and control vaccine
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double blind
| Experimental vaccine | Biological | A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection. |
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The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml |
| Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group |