> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-tetanus-vaccine-adsorbed-in-18-288842a6-ae49-49f1-b71e-11a000f27e0e
> Record changed: 2026-10-13

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

NCT06049940

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

Participants

1,260

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

Lead sponsor

Sinovac Life Sciences Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

Start date

2023-09-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Official title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Dates

**Completion date**

2024-03-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**First posted**

2023-09-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Registry last updated**

2024-07-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Primary completion date**

2023-10-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Start date**

2023-09-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Size and sites

**Actual participants**

1,260

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Participants**

1,260

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Randomisation ratio**

1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Lead sponsor**

Sinovac Life Sciences Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Identifiers

**Registry ID**

NCT06049940

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**ClinicalTrials.gov ID**

NCT06049940

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Outcomes

### Primary outcomes

1. Incidence of adverse reactions  
Timeframe: within 30 days after vaccination  
Incidence of adverse reactions within 30 days after vaccination.
2. Incidence of local or systemic adverse reactions  
Timeframe: Within 7 days after vaccination  
Incidence of local or systemic adverse reactions within 7 days after vaccination.
3. Incidence of grade 3 and above adverse reactions  
Timeframe: Within 30 days after vaccination  
Incidence of grade 3 and above adverse reactions within 30 days after vaccination
4. Incidence of SAE related to vaccination  
Timeframe: From the beginning of vaccination to 6 months after vaccination  
Incidence of SAE related to vaccination from the beginning of vaccination to 6 months after vaccination.

### Secondary outcomes

1. The seroprotective rate of anti-tetanus toxiod antibody  
Timeframe: 30 days after vaccination  
The seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
2. Long-term seroprotective rate of anti-tetanus toxiod antibody  
Timeframe: 30 days after vaccination  
Long-term seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
3. Seroconversion rate of anti-tetanus toxiod antibody  
Timeframe: 30 days after vaccination  
Seroconversion rate of anti-tetanus toxiod antibody 30 days after vaccination.
4. GMC of anti-tetanus toxiod antibody  
Timeframe: 30 days after vaccination  
GMC of anti-tetanus toxiod antibody 30 days after vaccination.
5. GMC increase folds (GMI) of anti-tetanus toxiod antibody  
Timeframe: 30 days after vaccination  
GMC increase folds (GMI) of anti-tetanus toxiod antibody 30 days after vaccination.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Eligibility

**Sex**

All

**Age groups**

Adults

**Minimum age**

18 Years

**Maximum age**

44 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- Healthy aldults aged 18-44 months;
- Proven legal identity;
- Subjects have the ability to understand and agree to sign the informed consent form.

### Exclusion criteria

- Armpit temperature of persons with fever on the day of experimental vaccine administration>37.0 ℃;
- Previous history of tetanus infection;
- Has received tetanus vaccines or vaccines containing tetanus toxoid antigen (DTP, DTP, meningococcal conjugate vaccine, etc.) within the last 10 years, or has received a tetanus immunoglobulin or tetanus antitoxin within the previous 6 months;
- Women who are lactating, pregnant (with a positive urine pregnancy test) or planning to become pregnant within the last 3 months;
- History of asthma, allergy to vaccines or vaccine components, and severe adverse reactions to vaccines, such as urticaria, dyspnea, angioedema, or abdominal pain;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Have congenital or acquired immunodeficiency such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA);
- Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
- Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc;
- Currently suffering from or have suffered from encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc.); A history of convulsions, epilepsy, psychosis or a family history of psychosis, and other serious neurological disorders;
- Diagnosed abnormal blood coagulation function (e.g. coagulation factor deficiency, coagulation disorders, abnormal platelets) or obvious bruising or coagulation disorders;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- A long history of alcohol or drug abuse;
- Receipt of blood products within in the past 3 months;
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Acute onset of various acute diseases or chronic diseases in the last 7 days;
- Participating in clinical studies of other vaccines or drugs;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Sites

- Liangyuan District Center for Disease Control and PreventionShangqiu, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06049940)

## Related records

### Drugs (1)

- [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md)

### Lead sponsors (1)

- [Sinovac Life Sciences Co., Ltd.](https://trialight.com/data/company/sinovac-life-sciences-co-ltd-d3dbe3ae-1264-4328-a691-a71dbc1efbbc.md)

### Conditions (1)

- [Tetanus](https://trialight.com/data/condition/tetanus-a589c209-81c5-56e6-8a55-6d96fedb2c61.md) Primary condition

### Targets (1)

- [IL1B](https://trialight.com/data/target/il1b-a893351e-84c8-5959-8b42-db764a8a634f.md)

---

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