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This is a randomized, double-blind, positive controlled design clinical trial of tetanus vaccine, adsorbed manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the safety and immunogenicity of tetanus vaccine, adsorbed in 18~44 years old population.
This is a randomized, double-blind, positive controlled design clinical trial of tetanus vaccine, adsorbed.The purpose of this study is to evaluate the safety and immunogenicity of tetanus vaccine, adsorbed in 18~44 years old population.The study will conduct in two phases.A total of 1260 subjects including 60 subjects in phase â… and 1200 subjects in phase III will be enrolled.All of subjects in phase â… and phase III will be randomly assigned 2 groups in a 1:1 ratio to receive one dose of experimental vaccine or control vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 630 Participants (including 30 subjects in phaseâ… , 600 subjects in phase â…¢ ) will receive one dose of experimental vaccine or control vaccine. |
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| Control Group | Active Comparator | 630 Participants (including 30 subjects in phaseâ… , 600 subjects in phase â…¢ ) will receive one dose of experimental vaccine or control vaccine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational tetanus vaccine, adsorbed | Biological | The investigational vaccine was manufactured by Sinovac Life Sciences Co., Ltd. There is not less than 40IU tetanus toxoid in 0.5ml per dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | Incidence of adverse reactions within 30 days after vaccination. | within 30 days after vaccination |
| Incidence of local or systemic adverse reactions | Incidence of local or systemic adverse reactions within 7 days after vaccination. | Within 7 days after vaccination |
| Incidence of grade 3 and above adverse reactions | Incidence of grade 3 and above adverse reactions within 30 days after vaccination | Within 30 days after vaccination |
| Incidence of SAE related to vaccination | Incidence of SAE related to vaccination from the beginning of vaccination to 6 months after vaccination. | From the beginning of vaccination to 6 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The seroprotective rate of anti-tetanus toxiod antibody | The seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination. | 30 days after vaccination |
| Long-term seroprotective rate of anti-tetanus toxiod antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiqing Xie | Henan Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liangyuan District Center for Disease Control and Prevention | Shangqiu | Henan | 450016 | China |
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| ID | Term |
|---|---|
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Control tetanus vaccine, adsorbed | Biological | The control tetanus vaccine, adsorbed was manufactured by Chengdu Olymvax Biopharmaceuticals Inc.There is not less than 40IU tetanus toxoid in 0.5ml per dose. |
|
Long-term seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
| 30 days after vaccination |
| Seroconversion rate of anti-tetanus toxiod antibody | Seroconversion rate of anti-tetanus toxiod antibody 30 days after vaccination. | 30 days after vaccination |
| GMC of anti-tetanus toxiod antibody | GMC of anti-tetanus toxiod antibody 30 days after vaccination. | 30 days after vaccination |
| GMC increase folds (GMI) of anti-tetanus toxiod antibody | GMC increase folds (GMI) of anti-tetanus toxiod antibody 30 days after vaccination. | 30 days after vaccination |
| D007239 | Infections |