Pertussis, whooping cough, Diphtheria, Tetanus
Conditions
Interventions
group B2:vaccinated with DTacP-IPV/Hib
group B3:vaccinated with DTacP
group A1:vaccinated with DTacP
group A2:vaccinated with DTaP
group A3:vaccinated with DTacP-IPV/Hib
group B1:vaccinated with DTacP
Sponsors
Henan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.1 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 2 months old (60-89 days) and 3 months old (90-119 days), willing to provide identification; 2. 2-month-old infants have not been vaccinated against diphtheria pertussis vaccine, inactivated polio vaccine, Haemophilus influenzae type b vaccine, or 13-valent pneumococcal polysaccharide conjugate vaccine; 3. 3-month-old infants have not been vaccinated against diphtheria pertussis vaccine, Haemophilus influenzae type b vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, group A group C meningococcal conjugate vaccine; 4. 3-month-old (group A3) infants who have not been vaccinated with inactivated polio vaccine at the same time; 5. The legal guardian or the entrusted person voluntarily signs the informed consent form after informed consent, and is able to comply with the requirements of the clinical research protocol.
Exclusion criteria
Exclusion criteria: 1. Axillary body temperature >= 37.3°C before vaccination; 2. History of pertussis, diphtheria and tetanus; 3. In the past 30 days, those who have had contact with individuals diagnosed with pertussis and diphtheria; 4. Preterm birth (delivery before the 37th week of pregnancy), low birth weight (weight at birth < 2500 g) infants; 5. Those with a history of dystocia, suffocation rescue, and nervous system damage; 6. Congenital deformities or developmental disorders, genetic defects, severe malnutrition, etc.; 7. Those with a history of epilepsy, convulsions, convulsions, cerebral palsy, or a history of mental illness or family history; or other progressive neurological diseases; 8. Those who received immune enhancement or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days); 9. Have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA) or other autoimmune diseases; 10. Asplenia and spleen dysfunction caused by any circumstances; 11. Known or suspected to have acute disease or serious chronic disease (including: severe respiratory disease, severe cardiovascular disease, liver and kidney disease, severe skin disease, malignant tumor, etc.); or in the acute attack period of chronic disease; 12. Abnormal coagulation function diagnosed by a doctor (such as coagulation factor deficiency, coagulation disease); 13. Has a history of severe allergic reactions to vaccination, such as dyspnea and urticaria; 14. Allergic to any component of the experimental vaccine; 15. Received live attenuated vaccines within 14 days; received other vaccines within 7 days; 16. Received blood products within 3 months before receiving the experimental vaccine; 17. Are or plan to participate in other clinical trials in the near future; 18. The investigator judges that other conditions are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse events;incidence of serious adverse events (SAE);Anti PT, FHA, PRN, D and T antibody positive conversion rate;Anti-PRN antibody >= 5, 10, 20 IU/ml ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti PT, FHA, PRN, D and T antibody positive conversion rate;Anti-PRN antibody >= 5, 10, 20 IU/ml ratio; | — |
Countries
China
Contacts
Public ContactWang Yanxia
Henan Provincial Center for Disease Control and Prevention
Outcome results
None listed