A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)

NCT07894055
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
420
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Lead sponsor
Changchun BCHT Biotechnology Co.
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Start date
2026-08-12
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Number of sites
1
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Summary
the immunogenicity and safety of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine
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Short title
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
clinicaltrials.gov
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-08-25
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First posted
2026-10-26
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Registry last updated
2026-10-26
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Primary completion date
2026-09-25
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Start date
2026-08-12
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Participants
420
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Participant count basis
Estimated
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Planned participants
420
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Changchun BCHT Biotechnology Co.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07894055
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ClinicalTrials.gov ID
NCT07894055
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Single masking
Masked roles
Participants
Sources for study design
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  1. Seroconversion rates and geometric mean concentration of anti-DT antibody

    Timeframe: 30 days after injection

  2. Seroconversion rates and geometric mean concentration of anti-TT antibody

    Timeframe: 30 days after injection

  3. Seroconversion rates and geometric mean concentration of anti-PT antibody

    Timeframe: 30 days after injection

  4. Seroconversion rates and geometric mean concentration of anti-FHA antibody

    Timeframe: 30 days after injection

  1. Number of participants with treatment-related adverse events

    Timeframe: 30 days after injection

  2. Number of participants with adverse events

    Timeframe: 30 days after injection

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
10 Years
Healthy volunteers
Yes

  • 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.

  • 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);
  • 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.
Sources for eligibility
clinicaltrials.gov

  • Ethics Review Committee of Zhejiang Provincial Center for Disease ControlLishui, ChinaRecruiting
Sources for sites
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