A Phase 3 interventional study of TTVA and TT in Tetanus, sponsored by CanSino Biologics Inc.. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by CanSino Biologics Inc. · Phase 3, Interventional, and Prevention
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.
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).
Exclusion Criteria:
1 dose of (TTVA) (0.5ml)
Biological: TTVA
1 dose of (TT) (0.5ml)
Biological: TT
Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
Positive serum conversions of anti-tetanus toxoid IgG antibodies.
Time frame: 30 days after immunization
Incidence of adverse reactions (AR).
Time frame: 0-30 days after immunization
Geometric mean multiplicity of increase (GMI) of anti-tetanus toxoid IgG antibodies in serum.
Time frame: 30 days after immunization
Positivity rate of anti-tetanus toxoid IgG antibodies in serum.
Time frame: 30 days after immunization
Geometric mean concentration (GMC) of anti-tetanus toxoid IgG antibodies in serum.
Time frame: 30 days after immunization
Proportion of serum with anti-tetanus toxoid IgG antibody concentration ≥1.0 IU/ml
Time frame: 30 days after immunization
Incidence of AR.
Time frame: 30 minutes after immunization
Incidence of adverse events (AE).
Time frame: 0-30 days after immunization
Incidence of AE/AR.
Time frame: 0-7 days post-immunization
Incidence of serious adverse events (SAEs).
Time frame: 6 months post-immunization
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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CanSino Biologics Inc.