Tetanus, Diphtheria and Acellular Pertussis VaccinationPhase 1/2NCT07418372
Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine
A Phase 1/2 study testing low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content), high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) and Tetanus, Diphtheria and Acellular Pertussis Vaccine in people with Tetanus, Diphtheria and Acellular Pertussis Vaccination and Tetanus, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Diphtheria and Acellular Pertussis Vaccination, Tetanus, Diphtheria
- What is being tested?
- low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content), high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) and Tetanus, Diphtheria and Acellular Pertussis Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2026to 31 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age Requirement: volunteers aged 6 years and above
- Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
Who cannot join
- Subjects whose physical examination, vital signs check, or laboratory test results are abnormal and have clinical significance, and are determined by the researcher to be unsuitable for participation in the clinical trial.
- Subjects who have received any vaccine within 30 days (including the 30th day) before enrollment, or those who plan to receive other vaccines within 30 days (including the 30th day) after receiving the investigational vaccine.
- Subjects who have experienced acute diseases (such as fever) or acute exacerbations of chronic diseases within 3 days before enrollment (including the third day).
- Subjects who have had contact with patients clearly diagnosed with pertussis, diphtheria or tetanus within 30 days before enrollment.
- Individuals who have been clinically diagnosed with diphtheria or tetanus within 10 years before enrollment, or with pertussis within 5 years; or those who have experienced paroxysmal spasmodic coughing for at least 14 days without fever within 5 years, and for which no other specific cause (such as influenza) can be identified, and have a history of exposure to pertussis or contact with confirmed cases.
- Subjects who have been diagnosed with serious diseases that may interfere with the conduct or completion of the trial.
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- Subjects who have shown allergic reactions to any component of the trial vaccine (such as aluminum adjuvant) before enrollment, or have experienced severe allergic reactions, suspected severe allergies (such as Arthus reaction, anaphylactic shock, laryngeal edema, allergic purpura, local allergic necrotic reaction, etc.) or other serious adverse reactions (such as thrombocytopenic purpura, breathing difficulties, angioneurotic edema, widespread rash, brachial plexus neuritis, etc.) to any vaccine or drug before enrollment.
- Subjects who have experienced convulsions, epilepsy, mental disorders before enrollment, or have a family history of such diseases, or have had severe brain diseases (such as hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumors, cerebral infarction, stroke, etc.) before enrollment.
- Subjects with coagulation disorders (such as deficiency of coagulation factors, coagulation diseases, and platelet abnormalities), or a history of bleeding disorders, or those with hereditary bleeding tendencies.
- Individuals with primary or secondary immune function impairment, or those who have been receiving immunosuppressive therapy for a long time (such as long-term systemic glucocorticoid treatment, for example, using prednisone or similar drugs for two weeks or more continuously, but local use such as ointments, eye drops, inhalants or nasal sprays is allowed), or those who plan to use it during the trial.
- Subjects who have had their spleen removed or undergone partial or complete removal of other vital organs (such as the liver, kidneys, lungs, pancreas, thyroid, stomach, intestines, and other vital organs) due to any cause.
- Subjects who have donated blood or lost blood (≥ 400 ml) within 6 months before enrollment, received blood transfusion or used blood products, or plan to receive blood transfusion or use blood products during the trial.
- Any investigational or unregistered products (drugs, biologics or devices) were used within 6 months before enrollment, or the subject plans to participate in or is currently participating in any clinical trial.
- Subjects who may be unable to follow the trial procedures, abide by the agreement, or plan to permanently relocate from this area during the trial period, or be away from the local area for a long time during the scheduled visits.
- Subjects deemed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jiangjin District Center for Disease Control and Prevention
Chongqing, Chongqing Municipality
Yu Liu, 023-47562909 ext. +86, 47723157@qq.com
About this study
Official title: A Randomized, Double-Blind, Parallel-Controlled Phase I/II Clinical Trial Evaluating the Safety and Immunogenicity of Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) Among Individuals Aged 6 Years and Above
This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.
- Conditions
- Tetanus, Diphtheria and Acellular Pertussis Vaccination, Tetanus, Diphtheria, Pertussis, Pertussis Vaccines
- Being tested
- low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content), high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content), Tetanus, Diphtheria and Acellular Pertussis Vaccine, 23-valent polysaccharide pneumococcal vaccine
- Medical subject headings
- Tetanus, Diphtheria, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)Biological
Low-dose vaccine, 0.5ml/dose, one dose at Day 0
high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)Biological
High-dose vaccine, 0.5ml/dose, one dose at Day 0
Tetanus, Diphtheria and Acellular Pertussis VaccineBiological
DTaP controlled vaccine, 0.5ml/dose, one dose at Day 0
23-valent polysaccharide pneumococcal vaccineBiological
PPV23 controlled vaccine, 0.5ml/dose, one dose at Day 0
| Study group | Role | What they receive |
|---|---|---|
| low-dose experimental group | Experimental | Participants aged 6 years and above Receives: Biological: low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) |
| high-dose experimental group | Experimental | Participants aged 6 years Receives: Biological: high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) |
| DTaP controlled group | Active comparator | Participants aged 6 years Receives: Biological: Tetanus, Diphtheria and Acellular Pertussis Vaccine |
| PPV23 controlled group | Placebo comparator | Participants aged 7 years and above Receives: Biological: 23-valent polysaccharide pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety index - incidence of adverse events
Incidence of adverse events after vaccination
Measured: 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after vaccination
Immunogenicity index - Geometric Mean Concentration (GMC)
The GMC of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Measured: Day 30 after vaccination
Immunogenicity index - Seropositive Rate
The seropositve rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Measured: Day 30 after vaccination
Secondary outcomes (3)
Safety index - incidence of serious adverse events
Incidence of serious adverse events after vaccination
Measured: From vaccination to 12 months after vaccination
Immunogenicity index - Seroconversion Rate
The seroconversion rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index - Geometric mean fold increases (GMFI)
The GMFI of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Measured: Between baseline and Day 30 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start12 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetanus, Diphtheria and Acellular Pertussis VaccinationStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiawei Xu, Principal investigator, Chongqing Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418372
- Sponsor's protocol ID
- Tdacp-101
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Controlled Phase I/II Clinical Trial Evaluating the Safety and Immunogenicity of Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) Among Individuals Aged 6 Years and Above
- ClinicalTrials.gov ID
- NCT07418372
- Acronym / sponsor ID
- Tdacp-101
- Conditions
- Tetanus, Diphtheria and Acellular Pertussis Vaccination, Tetanus, Diphtheria, Pertussis, Pertussis Vaccines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 12 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Feb 2026 (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-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low-dose experimental group | Experimental | Biological: low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)Participants aged 6 years and above |
| high-dose experimental group | Experimental | Biological: high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)Participants aged 6 years |
| DTaP controlled group | Active comparator | Biological: Tetanus, Diphtheria and Acellular Pertussis VaccineParticipants aged 6 years |
| PPV23 controlled group | Placebo comparator | Biological: 23-valent polysaccharide pneumococcal vaccineParticipants aged 7 years and above |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age Requirement: volunteers aged 6 years and above
- Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
Key exclusion criteria (15 listed)
- Subjects whose physical examination, vital signs check, or laboratory test results are abnormal and have clinical significance, and are determined by the researcher to be unsuitable for participation in the clinical trial.
- Subjects who have received any vaccine within 30 days (including the 30th day) before enrollment, or those who plan to receive other vaccines within 30 days (including the 30th day) after receiving the investigational vaccine.
- Subjects who have experienced acute diseases (such as fever) or acute exacerbations of chronic diseases within 3 days before enrollment (including the third day).
- Subjects who have had contact with patients clearly diagnosed with pertussis, diphtheria or tetanus within 30 days before enrollment.
- Individuals who have been clinically diagnosed with diphtheria or tetanus within 10 years before enrollment, or with pertussis within 5 years; or those who have experienced paroxysmal spasmodic coughing for at least 14 days without fever within 5 years, and for which no other specific cause (such as influenza) can be identified, and have a history of exposure to pertussis or contact with confirmed cases.
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 |
|---|---|---|
| low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)Low-dose vaccine, 0.5ml/dose, one dose at Day 0 | Biological | low-dose experimental group |
| high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)High-dose vaccine, 0.5ml/dose, one dose at Day 0 | Biological | high-dose experimental group |
| Tetanus, Diphtheria and Acellular Pertussis VaccineDTaP controlled vaccine, 0.5ml/dose, one dose at Day 0 | Biological | DTaP controlled group |
| 23-valent polysaccharide pneumococcal vaccinePPV23 controlled vaccine, 0.5ml/dose, one dose at Day 0 | Biological | PPV23 controlled group |
Primary outcome
Safety index - incidence of adverse events
Time frame: 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after vaccination
Incidence of adverse events after vaccination
Immunogenicity index - Geometric Mean Concentration (GMC)
Time frame: Day 30 after vaccination
The GMC of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Immunogenicity index - Seropositive Rate
Time frame: Day 30 after vaccination
The seropositve rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
3 secondary outcomes
Safety index - incidence of serious adverse events
Time frame: From vaccination to 12 months after vaccination
Immunogenicity index - Seroconversion Rate
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index - Geometric mean fold increases (GMFI)
Time frame: Between baseline and Day 30 after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Jiawei Xu principal investigator
Chongqing Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content), high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) and Tetanus, Diphtheria and Acellular Pertussis Vaccine in people with Tetanus, Diphtheria and Acellular Pertussis Vaccination and Tetanus, run by Institute of Medical Biology, Chinese Academy of Medical Sciences 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 15 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: opening soon, as of the sponsor's last update on 18 Feb 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingsi Yang (0871-68334551 ext. +86, yjs@imbcams.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety index - incidence of adverse events (time frame: 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after vaccination). The study lists 3 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 18 Feb 2026.