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 Ⅰ and 1200 subjects in phase III will be enrolled.All of subjects in phase Ⅰ and phase III will be randomly assigned 2 groups in a 1:1 ratio to receive one dose of experimental vaccine or control vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,260
The investigational vaccine was manufactured by Sinovac Life Sciences Co., Ltd. There is not less than 40IU tetanus toxoid in 0.5ml per dose.
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.
Liangyuan District Center for Disease Control and Prevention
Shangqiu, Henan, China
Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination.
Time frame: within 30 days after vaccination
Incidence of local or systemic adverse reactions
Incidence of local or systemic adverse reactions within 7 days after vaccination.
Time frame: 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
Time frame: 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.
Time frame: From the beginning of vaccination to 6 months after vaccination
The seroprotective rate of anti-tetanus toxiod antibody
The seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Long-term seroprotective rate of anti-tetanus toxiod antibody
Long-term seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Seroconversion rate of anti-tetanus toxiod antibody
Seroconversion rate of anti-tetanus toxiod antibody 30 days after vaccination.
Time frame: 30 days after vaccination
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GMC of anti-tetanus toxiod antibody
GMC of anti-tetanus toxiod antibody 30 days after vaccination.
Time frame: 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.
Time frame: 30 days after vaccination