Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP

• Register: ChiCTR
• Last refreshed on: 22 March 2021
• Main ID: ChiCTR2100041758
• Date of registration: 2021-01-04
• Prospective Registration: No
• Primary sponsor: Shaanxi Provincial Center for Disease Control and Prevention
• Public title: Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP
• Scientific title: A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate the Safety and Immunogenicity of Combined Immunization With Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero cell) and Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
• Date of first enrolment: 2019-06-27
• Target sample size: Combined immunization of sIPV and DTaP group:234;sIPV group:234;DTaP group:234;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=42011
• Study type: Interventional study
• Study design: Parallel
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Shaobai Zhang
• Affiliation: Shaanxi Provincial Center for Disease Control and Prevention

• Name: Shasha Han
• Affiliation: China National Biotec Group Company Limited

Key inclusion & exclusion 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: 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.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Polio,Pertussis,Diphtheria,Tetanus

Intervention(s)

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;

Primary Outcome(s)

geometric mean titres (GMTs);Seroconversion rate;Adverse reaction;

Source(s) of Monetary Support

China National Biotec Group Company Limited

Ethics review

Status: Approved
Approval date: 27/06/2019
Contact:

Hui Liu