NCT06049940

Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population

Randomized, Double-blind, Controlled Phase Ⅰ and Phase Ⅲ Clinical Trial to Evaluate the Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,260 (actual)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Investigational tetanus vaccine, adsorbed	The investigational vaccine was manufactured by Sinovac Life Sciences Co., Ltd. There is not less than 40IU tetanus toxoid in 0.5ml per dose.
BIOLOGICAL	Control tetanus vaccine, adsorbed	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2023-10-26
• Completion: 2024-03-22
• First posted: 2023-09-22
• Last updated: 2024-07-12

Locations

1 site across 1 country: China