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

• Register: ChiCTR
• Last refreshed on: 12 April 2021
• Main ID: ChiCTR2100042116
• Date of registration: 2021-01-14
• Prospective Registration: No
• Primary sponsor: Jiangsu Province Centers 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: 2019-07-22
• Target sample size: Combined immunization of sIPV and DTaP group:234;sIPV group:234;DTaP group:234;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=119683
• Study type: Interventional study
• Study design: Parallel
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Fenyang Tang
• Affiliation: Jiangsu Province Centers for Disease Control and Prevention

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

Key inclusion & exclusion criteria

Inclusion criteria: 1)Subjects aged 2 months old at the date of recruitment;
2)with informed consent signed by parent(s) or guardians;
3)parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
4)subjects have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines;
5)The interval between the last vaccination of the subjects >= 14 days;
6)Before entering this study, the body temperature was confirmed to be <= 37.0 degrees C by medical history and clinical examination.
Exclusion criteria: 1)Subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
2)Allergic to any ingredient of vaccine or with allergy history to any vaccine;
3)Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy (Taking orally injecting of steroid hormone);
4)Administration of immunoglobulins within 30 days prior to this study;
5)Acute febrile disease(temperature >= 37.0 degrees C) or infectious disease;
6)Have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
7)Any serious chronic illness, acute infectious diseases, or respiratory diseases;
8)Severe cardiovascular disease, liver and kidney diseases or diabetes with complications;
9)Various infectious, suppurative and allergic skin diseases;
10)Any situation that the researchers believe 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:For 2 months old, collect pre-immunization blood, vaccinate single dose of the first sIPV, 0.5ml per dose; for 3 months old vaccinate the second dose of sIPV and the first dose of DTaP simultaneously, 0.5ml per dose, and for 4 months old vaccinate the third dose of sIPV and the second dose o;sIPV group:For 2 months old, collect pre-immunization blood, vaccinate single dose of sIPV on 2 months old, 3 months old, 4 months old respectively, 0.5ml per dose. There is a one-month interval between each vaccination. After completing immune procedure, post-immunization blood will be collected on the age of 6 month;DTaP group:For 2 months old, collect pre-immunization blood, vaccinate single dose of sIPV on 2 months old, 0.5ml per dose; then vaccinate single dose of DTaP on 3 months old, 4 months old, 5 months old respectively, 0.5ml per dose. There is a one-month interval between each vaccination. After completing immune;

Primary Outcome(s)

Antibody positive rate ;Seroconversion rate;Geometric Mean Titres (GMT);Geometric Mean Titres (GMT);Geometric Mean Concentration (GMC);Geometric Mean Concentration (GMC);

Secondary Outcome(s)

Adverse Events Following Immunization (AEFI);

Source(s) of Monetary Support

Beijing Biological Products Institute Co., Ltd.

Ethics review

Status: Approved
Approval date: 22/07/2019
Contact:

Huiyuan Cai