Polio,Pertussis,Diphtheria,Tetanus
Conditions
Interventions
Combined immunization of sIPV and DTaP group:sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3, 4, 5 months old
sIPV group:Inoculation of 1 dose of sIPV at 3,4,5 months old
DTaP group:Inoculation of 1 dose of DTaP at 3, 4, 5 months old
Sponsors
Shaanxi Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged >= 3 months on the day of enrollment; 2. Informed consent was signed and dated by the subject's legal guardian; 3. The subjects and their legal guardians can participate in all planned follow-up visits and comply with all research procedures (such as completing diary cards and returning to visit); 4. The subjects had never been vaccinated with IPV vaccine, OPV vaccine, DPT vaccine and related vaccines; 5. The interval between the subjects and the last vaccination was more than 14 days; 6. Before entering this study, subjects whose body temperature was confirmed to be <= 37.0 degrees C by medical history and clinical examination.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history; 2. The subjects who are allergic to any component of the vaccine and have any history of severe allergy to the vaccine in the past; 3. Subjects suffering from immunodeficiency, cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or close family members with congenital immune diseases; 4. Subjects injected with non-specific immunoglobulin within one month before enrollment; 5. Patients with acute febrile diseases and infectious diseases whose body temperature is more than 37.0 degrees C; 6. Patients with a history of thrombocytopenia or other coagulation disorders may cause contraindications to subcutaneous injection; 7. Patients with known or suspected concurrent diseases, including respiratory diseases, acute infection or active chronic diseases; 8. Patients with severe cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes mellitus with complications; 9. Patients with various infectious, suppurative and allergic skin diseases; 10. Any situation that the researcher believes may affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| geometric mean titres (GMTs);Seroconversion rate;Adverse reaction; | — |
Countries
China
Contacts
Public ContactShaobai Zhang
Shaanxi Provincial Center for Disease Control and Prevention
Outcome results
None listed