Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

Inclusion Criteria:

1. Healthy infants and young children who are permanent residents aged 2 months (60-89days), and can provide valid identification documents for the subject and theirlegal guardian;

2. Obtain the informed consent of the subject's legal guardian and sign the informedconsent form;

3. The legal guardian of the subject can comply with the requirements of the clinicaltrial protocol.

Exclusion Criteria:

1. History of pertussis, diphtheria, or tetanus;

2. Contact with individuals diagnosed with pertussis or diphtheria within the past 30days;

3. Vaccination with vaccines containing DTaP components, inactivated poliovirusvaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Hib vaccine;

4. Premature infants (born before 37 weeks of gestation), infants with severe abnormallabor processes or a history of asphyxia rescue, or low birth weight infants (<2500g);

5. Axillary temperature >37.0°C on the day of enrollment*;

6. Severe congenital malformations or developmental disorders, genetic defects, severemalnutrition, or congenital diseases (such as Down syndrome, sickle cell anemia,congenital nervous system diseases, etc.);

7. History of epilepsy, convulsions, or seizures, history of cerebral palsy, or familyhistory of mental illness;

8. Autoimmune diseases or immunodeficiencies (such as perianal abscesses suggestingpossible immunodeficiency in infants, human immunodeficiency virus infection,lymphoma, leukemia, etc.), or parents/siblings with autoimmune diseases orimmunodeficiencies;

9. Asplenia or splenic dysfunction due to any cause;

10. Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies,coagulation diseases, platelet abnormalities) or obvious bruising/coagulationdisorders that may contraindicate intramuscular injection;

11. History of severe allergic diseases (such as anaphylactic shock, allergic laryngealedema, allergic purpura, thrombocytopenic purpura, local allergic necroticreactions), history of severe allergic reactions to any vaccine (widespreadurticaria, angioedema, etc.), or allergy to any known component of the test vaccine (pertussis toxoid, filamentous hemagglutinin, 69KD outer membrane protein,diphtheria toxoid, tetanus toxoid, aluminum hydroxide, sodium chloride, sodiumhydroxide, etc.);

12. Vaccination with subunit or inactivated vaccines within the past 7 days; vaccinationwith live attenuated vaccines within the past 14 days*;

13. Receipt of immunoglobulin and/or any blood products (except hepatitis Bimmunoglobulin) before enrollment;

14. Receipt of any immunostimulant or immunosuppressant therapy before enrollment (continuous oral administration or infusion for ≥14 days, or topical steroid use [inhaled, nasal spray, intra-articular, eye drops, ointments, etc.] exceeding therecommended dosage in the package insert);

15. Suffering from acute illnesses within 3 days before enrollment (acute illness isdefined as moderate or severe illness with or without fever)*;

16. Administration of prophylactic medications (such as antipyretic analgesics,antiallergic drugs, antidiarrheal drugs, etc.) within 3 days before enrollment*;

17. Known or suspected severe clinically diagnosed diseases (including but not limitedto severe diseases of the nervous, cardiovascular, hematological and lymphatic,immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletalsystems, as well as a history of malignant tumors);

18. Currently participating in other clinical trials or planning to participate in othertrials during the study period;

19. Any other factors that, in the judgment of the researcher, make the subjectunsuitable for participating in the clinical trial.