A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA-L)

• Register: ChiCTR
• Last refreshed on: 16 February 2021
• Main ID: ChiCTR2000040323
• Date of registration: 2020-11-27
• Prospective Registration: Yes
• Primary sponsor: Shaanxi Provincial Center for Disease Control and Prevention
• Public title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA-L)
• Scientific title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA-L)
• Date of first enrolment: 2020-12-11
• Target sample size: Group1 (sIPV+DTaP+HepA-L Group) :150;Group2 (sIPV Group) :150;Group3 (DTaP Group) :150;Group4 (HepA-L Group):150;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=64790
• Study type: Prevention
• Study design: Parallel
• Phase: 4

Countries of recruitment

China

Contacts

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

• Name: Haiping Chen
• Affiliation: China National Biotec Group Company Limited

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04054882) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
2. Subjects aged 18 months old at the date of recruitment;
3. With informed consent form (ICF) signed by parent(s) or guardian(s);
4. Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
5. Subjects have not been vaccinated with IPV, OPV, DPT vaccine and related vaccines, HepA-L at the age of 18 months;
6. No less than 14 days since the last dose of vaccination;
7. Axillary temperature <=37.0 degree C.
Exclusion criteria: 1. With 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 degree C) or infectious disease;
6. With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
7. With any serious chronic illness, acute infectious diseases, or respiratory diseases;
8. With any kind of infectious, purulent, or allergic skin diseases;
9. With any other factor that makes the investigator determines the subject is unsuitable for this study.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Polio,Pertussis,Diphtheria,Tetanus,Hepatitis A

Intervention(s)

Group1 (sIPV+DTaP+HepA-L Group) :Simultaneously administration of sIPV+DTaP+HepA-L as booster immunization at the age of 18 months old, 0.5 ml each, respectively ;Group2 (sIPV Group) :Vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old ;Group3 (DTaP Group) :Vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old ;Group4 (HepA-L Group):Vaccination of 0.5 ml HepA-L at the age of 18 months old;

Primary Outcome(s)

Antibody positive rate (sIPV);Seroconversion rate (sIPV);Antibody positive rate(DTaP);Seroconversion rate (DTaP);Antibody positive rate (HepA-L);Seroconversion rate(HepA-L);Geometric Mean Titres(GMT) (sIPV);Geometric Mean Titres (GMT) (sIPV);Geometric Mean Concentration (GMC) (DTaP);Geometric Mean Concentration (GMC) (DTaP);Geometric Mean Concentration (GMC) (HepA-L);Geometric Mean Concentration (GMC) (HepA-L);

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: 14/08/2020
Contact:

Hui Liu