Polio,Pertussis,Diphtheria,Tetanus,Hepatitis A
Conditions
Interventions
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
Sponsors
Shaanxi Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Adverse Events Following Immunization (AEFI); | — |
Countries
China
Contacts
Public ContactShaobai Zhang
Shaanxi Provincial Center for Disease Control and Prevention
Outcome results
None listed