Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China
Polio, Vaccine Reaction
About this trial
This is an interventional prevention trial for Polio focused on measuring Immunogenicity, Antibody persistence, Safety, Sabin IPV, bOPV
Eligibility Criteria
Inclusion Criteria:
- Participants aged ≥48 months to ≤ 51 months from preliminary study (NCT03147560) with sequential immunization history by Sabin IPV and bOPV.
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- ≥ 14 days interval between the last vaccination.
- Body temperature ≤ 37.2℃.
Exclusion Criteria:
- Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
- Known allergy to any constituent of the vaccine.
- Had 4 doses vaccination record of polio vaccine.
- Known impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin .
- Received non-specific immunoglobulin within 1 month.
- An acute illness with fever (temperature ≥ 37.3℃) or any infectious diseases.
- Patients with a well-diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications for injection.
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
Sites / Locations
- Chunan center for disease control and prevention
- Longyou Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Group A("Sabin IPV+ bOPV+ bOPV"+Sabin IPV)
Group B("Sabin IPV+ Sabin IPV+ bOPV"+bOPV)
Group C("Sabin IPV+ Sabin IPV+ bOPV"+Sabin IPV)
Group D("Sabin IPV+ Sabin IPV+ Sabin IPV"+bOPV)
Group E("Sabin IPV+ Sabin IPV+ Sabin IPV"+Sabin IPV)
Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 1 of preliminary study (NCT03147560).
Give the 4th doses of polio vaccine with bOPV for participants in the Group 2 of preliminary study (NCT03147560) after randomization.
Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 2 of preliminary study (NCT03147560) after randomization.
Give the 4th doses of polio vaccine with bOPV for participants in the Group 3 of preliminary study (NCT03147560) after randomization.
Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 3 of preliminary study (NCT03147560) after randomization.