A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)

Inclusion Criteria:

• Phase II : People ≥ 7 years old

• Phase II : Willing to provide identification documents

• Phase II : Volunteers must obtain informed consent from the volunteers themselvesand/or their guardians/ or delegates, sign the informed consent form and be willingto comply with the requirements of the clinical trial protocol, and be able tocomplete the full study follow-up

• Phase II : Volunteers aged 7~11 years have completed 4 doses of vaccine containingDPT

• Phase II : ≥12 years old volunteers need to have not received any component vaccinecontaining DPT within 5 years

• Phase III : People ≥6 years old

• Phase III : Willing to provide identification documents

• Phase III : Volunteers must obtain informed consent from themselves and/or theirguardians/ or delegates, sign the informed consent form and be willing to complywith the requirements of the clinical trial protocol, and be able to complete thefull study follow-up

• Phase III : Volunteers aged 6~11 years old have completed 4 doses of DPT-containingvaccine in the past

• Phase III : Volunteers aged ≥12 years should not have received any vaccinecontaining any component of DPT within 5 years

Exclusion Criteria:

• Those who have fever before vaccination, with axillary temperature >37.0℃;

• Females with a positive urine pregnancy test or breastfeeding volunteers, volunteersor their partners who have a pregnancy plan within 6 months;

• Suffering from hypertension (systolic blood pressure ≥160mmHg, diastolic bloodpressure ≥100mmHg) that cannot be controlled by medication (applicable to peopleaged 18 years and above);

• Those who have already suffered from one of the diphtheria or tetanus diseases,those who have suffered from whooping cough in the last 3 years; or those who havehad persistent cough for 14 days or more in the last 6 months;

• Those who have received vaccine containing pneumococcal polysaccharide/conjugatecomponent within 5 years (applicable to those aged 7 years and above);

• Individuals who have had household contact with an individual with a confirmeddiagnosis of pertussis, diphtheria, or tetanus disease in the past 30 days;

• Individuals who are allergic to the components of the test vaccine (e.g., aluminumadjuvant, sodium dihydrogen phosphate, sodium chloride, etc.) or who have developedan allergy to the same type of vaccine previously; individuals with a previoushistory of severe allergy, e.g., recurrent generalized urticaria, anaphylacticshock, respiratory distress, angioneurotic edema, or a history of asthma;

• Those with encephalopathy, uncontrolled epilepsy and other progressive neurologicaldisorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinatingdiseases)

• Persons with primary and secondary impaired immune function, receivingimmunosuppressive therapy

• Doctor-diagnosed coagulation abnormalities (e.g. coagulation factor deficiencies,coagulopathies, platelet abnormalities) or significant bruising or coagulationdisorders

• Currently suffering from severe chronic diseases, acute exacerbation of chronicdiseases, acute infectious diseases;

• Have received another investigational drug or vaccine within 1 month prior toreceiving the experimental vaccine, or have plans to participate or areparticipating in a clinical study of any other drug;

• Have received an injectable live attenuated vaccine within 14 days prior toreceiving the experimental vaccine, or any other vaccine within 7 days prior toreceiving the experimental vaccine;

• In the judgment of the investigator, the volunteer has any other factors that makehim/her unsuitable for participation in the clinical trial.