NCT06120751

A Clinical Trial to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in a Population Aged 18 Years and Over

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups, Subjects who gave informed consent and passed the questioning screen were randomly assigned 1:1 to be immunized with 1 dose of Tetanus Vaccine, Adsorbed (TTVA) or control vaccine.

Detailed description

Tetanus can be prevented with tetanus toxoid-containing vaccines (TT-containing vaccines, TTCVs), which are included globally in routine immunization programs for children, and in many countries at the time of prenatal care. China eliminated neonatal tetanus in 2012, but non-neonatal tetanus remains a serious public health problem. TT vaccine was first produced in 1924 and is used as a single antigen vaccine and combination vaccine component to prevent other vaccine-preventable diseases, including diphtheria, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b (Hib), and other vaccine-preventable diseases. Haemophilus influenzae type b (Hib).

Conditions

• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	TTVA	Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
BIOLOGICAL	TT	Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0

Timeline

• Start date: 2024-03-20
• Primary completion: 2024-04-30
• Completion: 2024-09-30
• First posted: 2023-11-07
• Last updated: 2024-12-02

Locations

1 site across 1 country: China