A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)

Inclusion Criteria:

• ≥ 6 years of age.

• Willingness to provide proof of identity.

• The informed consent of the volunteer and/or the guardian and/or the delegate mustbe obtained and the informed consent form must be signed.

• Volunteers are able and willing to comply with the requirements of the clinicaltrial protocol and are able to complete the full study follow up.

• Volunteers aged 6-11 years who have completed 4 doses of DPT-containing vaccine, buthave not received the 5th dose, and have ≥3 years between the 4th dose.

• Volunteers aged ≥12 years must not have received any of the components of theDPT-containing vaccine within 5 years.

Exclusion Criteria:

• Persons with fever prior to vaccination, with axillary temperature > 37.0°C.

• A female with a positive urine pregnancy test or a breastfeeding volunteer, wherethe volunteer or her partner has a plan to become pregnant within 180 days.

• Adults with severe cardiovascular disease, hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled bymedication, or other severe chronic diseases.

• Abnormal and clinically significant results of preimmunization blood tests, bloodbiochemistry and urine tests.

• Persons who have suffered from one of the diseases of diphtheria or tetanus, or whohave suffered from whooping cough in the last three years.

• Volunteers ≥12 years of age who have received pneumococcalpolysaccharide/conjugate-containing vaccine within 4 years.

• Individuals who have had household contact with individuals diagnosed withpertussis, diphtheria, tetanus in the past 30 days.

• Individuals who are allergic to the components of the study vaccine or who havedeveloped an allergy during previous administration of the same vaccine; individualswith a previous history of severe allergies, such as urticaria, anaphylaxis,respiratory distress, angioneurotic edema, or asthma.

• History of convulsions, epilepsy, encephalopathy and serious neurological disorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.),etc.

• Individuals with primary and secondary immune impairment (history of thyroid,pancreas, liver, spleen, kidney disease or removal, or need for treatment due tothyroid disease within the past 12 months), who have received immunosuppressivetherapy within 3 months.

• Physician-diagnosed coagulation abnormalities (e.g., coagulation factordeficiencies, coagulopathies, platelet abnormalities) or significant bruising orcoagulation disorders.

• Persons with acute febrile illnesses and current patients with infectious diseaseswho have had a history of moderately high fever (axillary temperature ≥38.0°C) orcardiopulmonary disease (frequent asthma attacks) within the past 3 days.

• Has received another investigational drug or vaccine within 1 month prior toreceiving the experimental drug, or is planning to participate or is participatingin a clinical study of any other drug.

• Received live attenuated vaccine within 14 days prior to receiving the test drug andsubunit vaccine or inactivated vaccine within 7 days prior to receiving the testdrug.

• Any other factors that, in the judgment of the investigator, make the volunteerunsuitable for participation in a clinical trial.