Pertussis (Whooping Cough)Phase 1NCT07492303
A Phase I Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
A Phase 1 study testing Tdap vaccine in people with Pertussis (Whooping Cough) and Diphtheria, run by Changchun BCHT Biotechnology Co..
Trial summary
the safety and tolerability of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pertussis (Whooping Cough), Diphtheria, Tetanus
- What is being tested?
- Tdap vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 20 Aug 2027
- Phase
- Phase 1
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- People aged 10 years or older;
- Study participants and/or their guardians/authorized representatives are willing to provide valid identity certification documents of the study participants and/or their guardians/authorized representatives;
- Informed consent of the study participants themselves and/or their guardians/authorized representatives shall be obtained, and informed consent forms shall be signed;
- Study participants themselves and/or their guardians/authorized representatives are able and willing to comply with the requirements of the clinical trial protocol and complete all trial follow-up visits;
- Study participants aged 10 to 11 years have not received any vaccine containing any component of Diphtheria, Tetanus and Pertussis within 3 years; - study participants aged 12 years or older have not received any vaccine containing any component of Diphtheria, Tetanus and Pertussis within 5 years;
- Women of childbearing potential have used effective contraceptive measures within 2 weeks prior to enrollment in this trial, have a negative urine pregnancy test before administration of the investigational vaccine (pregnancy test may be waived for non-childbearing potential women), and voluntarily agree to use effective contraceptive measures within 6 months after vaccination; male study participants must agree to use effective contraceptive methods with their female partners within 6 months after vaccination.
Who cannot join
- Axillary body temperature >37.0°C on the day of enrollment of trial participants;
- Female trial participants who are breastfeeding or pregnant, or trial participants or their partners who plan to conceive within 6 months;
- Persons with severe cardiovascular diseases, uncontrolled hypertension (e.g., systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg for trial participants aged 18-59 years before enrollment, or systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg for trial participants aged 60 years and above) or other severe chronic diseases (for persons aged 18 years and above);
- Persons with clinically significant abnormal results of pre-vaccination tests of blood routine, blood biochemistry, urine routine, and coagulation function indicators who are deemed unsuitable for vaccination by the investigator after comprehensive evaluation;
- Persons with a confirmed history of diphtheria, tetanus, or pertussis within the past 5 years; or persons who have had close contact with individuals diagnosed with pertussis, diphtheria, or tetanus within the past 30 days;
- Persons who have experienced persistent cough ≥14 days without fever in the absence of other specific etiologies (e.g., influenza) within the past 6 months;
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- Persons known to be allergic to any component of the investigational vaccine used in this clinical trial, or who had allergic reactions following previous administration of the same type of vaccine; persons with a history of severe allergy to any vaccine or drug, including but not limited to severe urticaria, anaphylactic shock, dyspnea, angioneurotic edema, anaphylactoid purpura, local allergic necrotizing reaction (Arthus reaction), etc.;
- Persons with a history or family history of convulsions, epilepsy, encephalopathy (e.g., brain nerve tissue damage caused by congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical drug poisoning, etc.), or mental illness;
- Persons with primary or secondary immune impairment (e.g., severe history of or resection of thyroid, pancreas, liver, spleen, or kidney diseases, autoimmune diseases, malignant tumors, or requiring treatment for thyroid immune dysfunction diseases within the past 12 months);
- Long-term use of immunosuppressants or other immunomodulatory drugs within 3 months before enrollment (e.g., prednisone or equivalent dose of similar drugs used at ≥0.5 mg/kg/day for trial participants aged 10-17 years, or ≥20 mg/day for trial participants aged 18-60 years, for 14 consecutive days or more);
- Persons diagnosed by a physician with coagulation abnormalities (e.g., coagulation factor deficiency, coagulopathy, platelet abnormalities) or coagulation disorders;
- Persons who have received immune globulin, blood or blood-related products within the past 3 months, plan to use such products during the trial, or have a history of blood transfusion within the past 3 months;
- Persons with any acute infectious disease, febrile illness (axillary body temperature ≥38.0°C), cardiopulmonary disease (frequently occurring asthma), acute exacerbation of chronic diseases, or use of antipyretic, analgesic or antiallergic drugs within 3 days before vaccination;
- Persons who have received other investigational drugs or vaccines within 1 month before vaccination, or plan to participate in or are currently participating in any other clinical trials;
- Persons who have received live attenuated vaccines within 14 days before vaccination, or subunit vaccines or inactivated vaccines within 7 days before vaccination;
- Persons with any other factors deemed unsuitable for participation in the clinical trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of Adsorbed Acellular Pertussis (Two-component) Diphtheria-tetanus Combined Vaccine (for Adults and Adolescents) in People Aged 10 Years and Older in a Randomized, Blinded, Placebo-controlled Manner
the safety and tolerability of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine
Read the detailed description
14day and 30 days after exemption
- Conditions
- Pertussis (Whooping Cough), Diphtheria, Tetanus
- Being tested
- Tdap vaccine
- Medical subject headings
- Whooping Cough, Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tdap vaccineBiological
intramuscular injection only, and the preferred inoculation site is the deltoid muscle of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| BCHT Tdap vaccine （low dose） | Experimental | low dose vaccine Receives: Biological: Tdap vaccine |
| BCHT Tdap vaccine （high dose） | Experimental | high dose vaccine Receives: Biological: Tdap vaccine |
| Control | Placebo comparator | Placebo Receives: Biological: Tdap vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse event
Measured: 14/30 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis (Whooping Cough)Studies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492303
- Sponsor's protocol ID
- LX01-2201-F20250122-1
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of Adsorbed Acellular Pertussis (Two-component) Diphtheria-tetanus Combined Vaccine (for Adults and Adolescents) in People Aged 10 Years and Older in a Randomized, Blinded, Placebo-controlled Manner
- ClinicalTrials.gov ID
- NCT07492303
- Acronym / sponsor ID
- LX01-2201-F20250122-1
- Conditions
- Pertussis (Whooping Cough), Diphtheria, Tetanus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 25 Mar 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.
the safety and tolerability of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine
Detailed description
14day and 30 days after exemption
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCHT Tdap vaccine （low dose） | Experimental | Biological: Tdap vaccinelow dose vaccine |
| BCHT Tdap vaccine （high dose） | Experimental | Biological: Tdap vaccinehigh dose vaccine |
| Control | Placebo comparator | Biological: Tdap vaccinePlacebo |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- People aged 10 years or older;
- Study participants and/or their guardians/authorized representatives are willing to provide valid identity certification documents of the study participants and/or their guardians/authorized representatives;
- Informed consent of the study participants themselves and/or their guardians/authorized representatives shall be obtained, and informed consent forms shall be signed;
- Study participants themselves and/or their guardians/authorized representatives are able and willing to comply with the requirements of the clinical trial protocol and complete all trial follow-up visits;
- Study participants aged 10 to 11 years have not received any vaccine containing any component of Diphtheria, Tetanus and Pertussis within 3 years; - study participants aged 12 years or older have not received any vaccine containing any component of Diphtheria, Tetanus and Pertussis within 5 years;
Key exclusion criteria (16 listed)
- Axillary body temperature >37.0°C on the day of enrollment of trial participants;
- Female trial participants who are breastfeeding or pregnant, or trial participants or their partners who plan to conceive within 6 months;
- Persons with severe cardiovascular diseases, uncontrolled hypertension (e.g., systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg for trial participants aged 18-59 years before enrollment, or systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg for trial participants aged 60 years and above) or other severe chronic diseases (for persons aged 18 years and above);
- Persons with clinically significant abnormal results of pre-vaccination tests of blood routine, blood biochemistry, urine routine, and coagulation function indicators who are deemed unsuitable for vaccination by the investigator after comprehensive evaluation;
- Persons with a confirmed history of diphtheria, tetanus, or pertussis within the past 5 years; or persons who have had close contact with individuals diagnosed with pertussis, diphtheria, or tetanus within the past 30 days;
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 |
|---|---|---|
| Tdap vaccineintramuscular injection only, and the preferred inoculation site is the deltoid muscle of the upper arm. | Biological | BCHT Tdap vaccine （high dose）, BCHT Tdap vaccine （low dose）, Control |
Primary outcome
adverse event
Time frame: 14/30 days after injection
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 25 Mar 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tdap vaccine in people with Pertussis (Whooping Cough) and Diphtheria, run by Changchun BCHT Biotechnology Co..
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 6 inclusion and 16 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 Xi Hualong (0431-87078295, xihualong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse event (time frame: 14/30 days after injection). 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 25 Mar 2026.