Pertussis (Whooping Cough)Phase 2NCT07894055
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
A Phase 2 study testing Tdap vaccine in people with Pertussis (Whooping Cough) and Diphtheria, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
the immunogenicity and safety 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
- 420 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2026to 25 Aug 2027
- Phase
- Phase 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Population aged ≥10 years old;
- The participant and/or their guardian/authorized representative is willing to provide valid identity-certifying documents of the trial participant and/or their guardian/authorized representative;
- Informed consent shall be obtained from the participant themself and/or their guardian/authorized representative, and the informed consent form shall be signed;
- The participant themself and/or their guardian/authorized representative is capable of and willing to comply with the requirements of the clinical trial protocol and complete the full-trial follow-up.
- participants aged 10-11 years have not received any vaccine containing any component of diphtheria-tetanus-pertussis within the past 3 years; trial participants aged ≥12 years have not received any vaccine containing any component of diphtheria-tetanus-pertussis within the past 5 years;
- Women of child-bearing potential have used effective contraception within 2 weeks prior to enrollment in this trial, and have a negative urine pregnancy test prior to administration of the investigational vaccine (the pregnancy test may be waived for non-child-bearing-potential women), and voluntarily agree to use effective contraception for 6 months after vaccination; male trial participants must agree to use effective contraception with their female partners for 6 months after vaccination.
Who cannot join
- temperature >37.0℃ on the day of enrollment;
- Female participants who are lactating or pregnant, or trial participants or their partners with a pregnancy plan within 180 days;
- Suffering from severe cardiovascular diseases, medically uncontrolled hypertension (e.g., systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg for subjects aged 18-59 years prior to enrollment; systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg for subjects aged 60 years and above) or other severe chronic diseases (for persons aged 18 years and above);
- Confirmed medical history of diphtheria, tetanus or pertussis within the past 5 years; or having had close contact with individuals diagnosed with pertussis, diphtheria or tetanus in the past 30 days;
- Persistent cough lasting ≥14 days without other specific etiologies (such as influenza) and unaccompanied by fever within the previous 6 months;
- Known allergy to any component of the investigational vaccine for this clinical trial, or history of allergy following prior administration of the same vaccine; history of severe allergic reactions to any vaccine or medicinal product, including but not limited to severe urticaria, anaphylactic shock, dyspnea, angioneurotic edema, allergic purpura, and local allergic necrotic reaction (Arthus reaction);
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- Personal or family history of convulsions, epilepsy, encephalopathy (e.g., cerebral nerve tissue injury caused by congenital hypoplasia of the brain, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical drug poisoning, etc.) or psychiatric disorders;
- Persons with primary or secondary impaired immune function (e.g., severe medical history or resection history of thyroid, pancreas, liver, spleen or kidney, autoimmune diseases, malignant tumors, or requiring treatment for thyroid immune-mediated disorders within the past 12 months);
- Long-term use of immunosuppressants or other immunomodulatory drugs within 3 months prior to enrollment (e.g., equivalent dose of prednisone or similar agents ≥0.5 mg/kg/day for subjects aged 10-17 years, or ≥20 mg/day for subjects aged 18-60 years, administered continuously for 14 days or longer);
- Physician-diagnosed coagulation dysfunction (e.g., coagulation factor deficiency, coagulopathy, platelet abnormalities) or bleeding disorders;
- Received immunoglobulins, blood or blood-related products within the past 3 months or planned to receive such products during the trial period, or having a history of blood transfusion within the past 3 months;
- Having acute exacerbation of any infectious disease, febrile illness (axillary temperature ≥38.0℃), cardiopulmonary disease (frequently-exacerbated asthma), acute flare-up of chronic disease, or having taken antipyretic-analgesic or anti-allergic drugs within 3 days before vaccination; Received any other investigational drugs or vaccines within 1 month prior to vaccination, or plan to participate in or are participating in any other clinical trials;
- Recipients who have received live-attenuated vaccines within 14 days before vaccination, or subunit vaccines or inactivated vaccines within 7 days before vaccination;
- In the investigator's judgment, the trial participant has any other factors rendering them ineligible for participation in the clinical trial.
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, 1 recruiting
- Recruiting
Ethics Review Committee of Zhejiang Provincial Center for Disease Control
Lishui, Zhejiang
Jiang Zhenggang, 87115105
About this study
Official title: A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety 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 immunogenicity and safety of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine
- Conditions
- Pertussis (Whooping Cough), Diphtheria, Tetanus
- Being tested
- Tdap vaccine, Placebo
- 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.
PlaceboBiological
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: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rates and geometric mean concentration of anti-DT antibody
Measured: 30 days after injection
Seroconversion rates and geometric mean concentration of anti-TT antibody
Measured: 30 days after injection
Seroconversion rates and geometric mean concentration of anti-PT antibody
Measured: 30 days after injection
Seroconversion rates and geometric mean concentration of anti-FHA antibody
Measured: 30 days after injection
Secondary outcomes (2)
Number of participants with treatment-related adverse events
Measured: 30 days after injection
Number of participants with adverse events
Measured: 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 posted26 Oct 2026
- Study start12 Aug 2026
- Primary completion25 Sep 2026
- Study completion25 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.
- More trials run by Changchun BCHT Biotechnology Co.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 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
- NCT07894055
- Sponsor's protocol ID
- LX01-2201-F20250122-2
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety 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
- NCT07894055
- Acronym / sponsor ID
- LX01-2201-F20250122-2
- Conditions
- Pertussis (Whooping Cough), Diphtheria, Tetanus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Aug 2027 (estimated)
- First posted
- 26 Oct 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 immunogenicity and safety of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine
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: Placeboplacebo |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Population aged ≥10 years old;
- The participant and/or their guardian/authorized representative is willing to provide valid identity-certifying documents of the trial participant and/or their guardian/authorized representative;
- Informed consent shall be obtained from the participant themself and/or their guardian/authorized representative, and the informed consent form shall be signed;
- The participant themself and/or their guardian/authorized representative is capable of and willing to comply with the requirements of the clinical trial protocol and complete the full-trial follow-up.
- participants aged 10-11 years have not received any vaccine containing any component of diphtheria-tetanus-pertussis within the past 3 years; trial participants aged ≥12 years have not received any vaccine containing any component of diphtheria-tetanus-pertussis within the past 5 years;
Key exclusion criteria (14 listed)
- temperature >37.0℃ on the day of enrollment;
- Female participants who are lactating or pregnant, or trial participants or their partners with a pregnancy plan within 180 days;
- Suffering from severe cardiovascular diseases, medically uncontrolled hypertension (e.g., systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg for subjects aged 18-59 years prior to enrollment; systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg for subjects aged 60 years and above) or other severe chronic diseases (for persons aged 18 years and above);
- Confirmed medical history of diphtheria, tetanus or pertussis within the past 5 years; or having had close contact with individuals diagnosed with pertussis, diphtheria or tetanus in the past 30 days;
- Persistent cough lasting ≥14 days without other specific etiologies (such as influenza) and unaccompanied by fever within the previous 6 months;
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） |
| Placebointramuscular injection only, and the preferred inoculation site is the deltoid muscle of the upper arm. | Biological | Control |
Primary outcome
Seroconversion rates and geometric mean concentration of anti-DT antibody
Time frame: 30 days after injection
Seroconversion rates and geometric mean concentration of anti-TT antibody
Time frame: 30 days after injection
Seroconversion rates and geometric mean concentration of anti-PT antibody
Time frame: 30 days after injection
Seroconversion rates and geometric mean concentration of anti-FHA antibody
Time frame: 30 days after injection
2 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 30 days after injection
Number of participants with adverse events
Time frame: 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 26 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tdap vaccine in people with Pertussis (Whooping Cough) and Diphtheria, run by Changchun BCHT Biotechnology Co. 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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 26 Oct 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 phase mean?
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 Chen Xin (0431-87078295, chenxin@bchtpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rates and geometric mean concentration of anti-DT antibody (time frame: 30 days after injection). 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 26 Oct 2026.