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

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

Overview

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

Interventions

• Biological Tdap vaccine
  intramuscular injection only, and the preferred inoculation site is the deltoid muscle of the upper arm.

Primary outcome measures

• adverse event [Time frame: 14/30 days after injection]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07492303 · LX01-2201-F20250122-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗