Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetanus Vaccine, Adsorbed (TTVA) | Experimental | 1 dose of (TTVA) (0.5ml) |
|
| Tetanus Vaccine, Adsorbed (TT) | Active Comparator | 1 dose of (TT) (0.5ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTVA | Biological | Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive serum conversions of anti-tetanus toxoid IgG antibodies. | 30 days after immunization | |
| Incidence of adverse reactions (AR). | 0-30 days after immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean multiplicity of increase (GMI) of anti-tetanus toxoid IgG antibodies in serum. | 30 days after immunization | |
| Positivity rate of anti-tetanus toxoid IgG antibodies in serum. | 30 days after immunization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shiguang Lei | Guizhou Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Disease Control and Prevention, Qixingguan District, Bijie City | Bijie | Guizhou | China |
Not provided
| ID | Term |
|---|---|
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TT | Biological | Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0 |
|
| Geometric mean concentration (GMC) of anti-tetanus toxoid IgG antibodies in serum. | 30 days after immunization |
| Proportion of serum with anti-tetanus toxoid IgG antibody concentration ≥1.0 IU/ml | 30 days after immunization |
| Incidence of AR. | 30 minutes after immunization |
| Incidence of adverse events (AE). | 0-30 days after immunization |
| Incidence of AE/AR. | 0-7 days post-immunization |
| Incidence of serious adverse events (SAEs). | 6 months post-immunization |
| D007239 | Infections |