TetanusPhase 3NCT06049940
Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
A Phase 3 study testing Investigational tetanus vaccine, adsorbed in people with Tetanus, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- Investigational tetanus vaccine, adsorbed
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 22 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy aldults aged 18-44 months;
- Proven legal identity;
- Subjects have the ability to understand and agree to sign the informed consent form.
Who cannot join
- 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.;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Liangyuan District Center for Disease Control and Prevention
Shangqiu, Henan, 450016
About this study
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
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.
Read the 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
- Being tested
- Investigational tetanus vaccine, adsorbed, Control tetanus vaccine, adsorbed
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational tetanus vaccine, adsorbedBiological
The investigational vaccine was manufactured by Sinovac Life Sciences Co., Ltd. There is not less than 40IU tetanus toxoid in 0.5ml per dose.
Control tetanus vaccine, adsorbedBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine. Receives: Biological: Investigational tetanus vaccine, adsorbed |
| Control Group | Active comparator | 630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine. Receives: Biological: Control tetanus vaccine, adsorbed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination.
Measured: within 30 days after vaccination
Incidence of local or systemic adverse reactions
Incidence of local or systemic adverse reactions within 7 days after vaccination.
Measured: Within 7 days after vaccination
Incidence of grade 3 and above adverse reactions
Incidence of grade 3 and above adverse reactions within 30 days after vaccination
Measured: Within 30 days after vaccination
Incidence of SAE related to vaccination
Incidence of SAE related to vaccination from the beginning of vaccination to 6 months after vaccination.
Measured: From the beginning of vaccination to 6 months after vaccination
Secondary outcomes (5)
The seroprotective rate of anti-tetanus toxiod antibody
The seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
Measured: 30 days after vaccination
Long-term seroprotective rate of anti-tetanus toxiod antibody
Long-term seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
Measured: 30 days after vaccination
Seroconversion rate of anti-tetanus toxiod antibody
Seroconversion rate of anti-tetanus toxiod antibody 30 days after vaccination.
Measured: 30 days after vaccination
GMC of anti-tetanus toxiod antibody
GMC of anti-tetanus toxiod antibody 30 days after vaccination.
Measured: 30 days after vaccination
GMC increase folds (GMI) of anti-tetanus toxiod antibody
GMC increase folds (GMI) of anti-tetanus toxiod antibody 30 days after vaccination.
Measured: 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Sep 2023
- Primary completion26 Oct 2023
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhiqing Xie, Principal investigator, Henan Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049940
- Sponsor's protocol ID
- PRO-TT-3001
- Status last verified
- Jul 2024
- First submitted
- 15 Sep 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06049940
- Acronym / sponsor ID
- PRO-TT-3001
- Conditions
- Tetanus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Investigational tetanus vaccine, adsorbed630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine. |
| Control Group | Active comparator | Biological: Control tetanus vaccine, adsorbed630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy aldults aged 18-44 months;
- Proven legal identity;
- Subjects have the ability to understand and agree to sign the informed consent form.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational tetanus vaccine, adsorbedThe investigational vaccine was manufactured by Sinovac Life Sciences Co., Ltd. There is not less than 40IU tetanus toxoid in 0.5ml per dose. | Biological | Experimental Group |
| Control tetanus vaccine, adsorbedThe control tetanus vaccine, adsorbed was manufactured by Chengdu Olymvax Biopharmaceuticals Inc.There is not less than 40IU tetanus toxoid in 0.5ml per dose. | Biological | Control Group |
Primary outcome
Incidence of adverse reactions
Time frame: within 30 days after vaccination
Incidence of adverse reactions within 30 days after vaccination.
Incidence of local or systemic adverse reactions
Time frame: Within 7 days after vaccination
Incidence of local or systemic adverse reactions within 7 days after vaccination.
Incidence of grade 3 and above adverse reactions
Time frame: Within 30 days after vaccination
Incidence of grade 3 and above adverse reactions within 30 days after vaccination
Incidence of SAE related to vaccination
Time frame: 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.
5 secondary outcomes
The seroprotective rate of anti-tetanus toxiod antibody
Time frame: 30 days after vaccination
Long-term seroprotective rate of anti-tetanus toxiod antibody
Time frame: 30 days after vaccination
Seroconversion rate of anti-tetanus toxiod antibody
Time frame: 30 days after vaccination
GMC of anti-tetanus toxiod antibody
Time frame: 30 days after vaccination
GMC increase folds (GMI) of anti-tetanus toxiod antibody
Time frame: 30 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiqing Xie principal investigator
Henan Provincial Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational tetanus vaccine, adsorbed in people with Tetanus, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: within 30 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.