Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine

Inclusion Criteria:

• 2 months of age (60~89 days), willing to provide identification documents;

• The legal guardian or delegate has given informed consent, voluntarily signed theinformed consent form, and can comply with the requirements of the clinical researchprotocol.

Exclusion Criteria:

First dose exclusion criteria

• Persons who have received a vaccine containing the DPT classified vaccine;

• Premature labor (delivery before 37th week of gestation), low birth weight 60 (birthweight <2500g);

• Those with abnormal labor and delivery, history of asphyxia rescue, history ofneurological damage;

• Who have had one of the pertussis, diphtheria or tetanus diseases;

• Who have had household contact with an individual diagnosed with pertussis,diphtheria, or tetanus disease in the past 30 days;

• Have a history of allergy to vaccines or vaccine components and severe sidereactions to vaccines, such as hives, dyspnea, angioneurotic edema, and otherallergic reactions;

• Persons with a history of seizures, convulsions, convulsions, or cerebral palsy; ora history or family history of psychiatric illness; or other progressive neurologicdisorders;

• Have been diagnosed with an immunodeficiency, Human Immunodeficiency Virus (HIV)infection, lymphoma, leukemia, Systemic Lupus Erythematosus (SLE), JuvenileRheumatoid Arthritis ( Juvenile Rheumatoid Arthritis (JRA) or other autoimmunediseases;

• Any condition resulting in absence of spleen, defective spleen function;

• Known or suspected acute illness or severe chronic disease (including: severerespiratory disease, severe cardiovascular disease, liver or kidney disease, severeskin disease, malignancy, etc.); or in an acute exacerbation of a chronic disease;

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

• Immunosuppressive or modifying agents, cytotoxic consecutive therapy for more than 10 days (except inhaled and topical steroids) within 2 months prior to receiving thetest vaccine;

• Received blood products (other than hepatitis B immune globulin) within 2 monthsprior to receiving the test vaccine;

• Participated or planning to participate in any other drug or vaccine clinical study;

• Has received an injectable live attenuated vaccine within 14 days or another vaccinewithin 7 days prior to receiving the test vaccine;

• Axillary temperature >37.3°C prior to vaccination;

• Any other factor that, in the investigator's judgment, makes the subject unsuitablefor participation in a clinical trial.

Exclusion Criteria for Doses 2,3

• Persons who have had a severe allergic reaction following a previous dose ofvaccine;

• Persons with serious adverse reactions causally related to the previous dose ofvaccination;

• Those with a newly identified or newly occurring condition after the first dose ofvaccination that does not meet the inclusion criteria for the first dose or meetsthe exclusion criteria for the first dose, as determined by the investigator forcontinued participation in the study;

• Other reasons for exclusion as determined by the investigator.