Diphtheria, Tetanus, Pertussis
Conditions
Interventions
1B:0.5ml, once by Intramuscular
2B:0.5ml, once by Intramuscular
3A:0.5ml, one dose each in 3, 4, 5 month
3B:0.5ml, one dose each in 3, 4, 5 month
3C:0.5ml, one dose each in 3, 4, 5 month
4A:0.5ml, one dose each in 2, 3, 4 month
4B:0.5ml, one dose each in 2, 3, 4 month
4C:0.5ml, one dose each in 2, 3, 4 month
Sponsors
He'nan Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
No minimum to 6 Years
Inclusion criteria
Inclusion criteria: 1. Healthy people aged 2 months, 3 months, 18-24 months and 4-6 years; 2. Subjects willing to provide identification materials; 3. The guardian or the client's informed consent and sign the informed consent; 4. The guardian or entrusted person who can comply with the requirements of the clinical research program; 5. The healthy person determined by the investigator after medical history inquiry and physical examination; 6. 2-month-old infants who were not vaccinated with DPT, IPV, Hib and 13 valent pneumococcal polysaccharide conjugate vaccine; 7. 3-month-old infants who have not been vaccinated with DPT, Hib, 13 valent pneumococcal polysaccharide combined vaccine, AC group meningococcal combined vaccine, and 3-month-old infants (Group C3) who have not been vaccinated with IPV at the same time; 8. 18-24-month-old subjects who have completed three doses of DTaP vaccine and have not been immunized with DPT vaccine; 9. 4-6-year-old subjects who have completed DTaP vaccine or similar type vaccine containing DPT, but have not received DT vaccine; 10. A healthy person determined by the investigator after medical history inquiry and physical examination.
Exclusion criteria
Exclusion criteria: 1. Preterm delivery (delivery before the 37th week of pregnancy) or low weight (birth weight of girls < 2300G, boys < 2500g) children under 1 year old; 2. Subjects with abnormal labor process and asphyxia rescue history; 3. Subjects who have suffered from pertussis, diphtheria or tetanus; 4. Subjects who had contact with individuals with pertussis, diphtheria and tetanus in their families in the past 30 days; 5. Subjects with allergic constitution; 6. Subjects who have a history of allergy to vaccines or vaccine ingredients and have serious side effects on vaccines, such as allergy, urticaria, dyspnea, angioneuroedema or abdominal pain; 7. Subjects with congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.; 8. Subjects with history of epilepsy, convulsion or convulsion, or with psychosis family; 9. Subjects with autoimmune diseases or immunodeficiency, or parents, brothers and sisters with autoimmune diseases or immunodeficiency; 10. Subjects who need treatment due to thyroid diseases; 11. Subjects with abnormal coagulation function (such as lack of coagulation factor, coagulation disease, platelet abnormality) or obvious swelling or coagulation disorder diagnosed by doctors; 12. Subjects without spleen, functional without spleen, and without spleen or splenectomy caused by any circumstances; 13. Subjects with acute attack of various acute or chronic diseases in the past 7 days; 14. Subjects who have had immunosuppressant or modulator, antiallergic and cytotoxic continuous treatment (more than 10 days) in the past 6 months are allowed to inhale and use steroids locally; 15. Subjects who have received blood products within 3 months before receiving the test vaccine; 16. Subjects who have received other research drugs or vaccines within one month before receiving the trial vaccine; 17. Subjects who plan to participate or are participating in any other drug clinical study; 18. Subjects who had received live attenuated vaccine within 14 days before receiving the test vaccine; 19. Subjects who have received subunit vaccine or inactivated vaccine within 7 days before receiving test vaccine; 20. The axillary temperature of the subjects who had fever before vaccination was higher than 37.0 degrees C; 21. According to the judgment of the investigator, there are any other factors that are not suitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse reactions;Occurrence of SAE;abnormal changes of hetatological examination and clinical biochemistry examination; | — |
Countries
China
Contacts
Public ContactWang Yanxia
He'nan Center for Disease Control and Prevention
Outcome results
None listed