Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China

Zhejiang Provincial Center for Disease Control and Prevention

Status and phase: Completed; Phase 4

Conditions: Vaccine Reaction; Polio

Treatments: Biological: vaccinated with bOPV; Biological: vaccinated with Sabin IPV

Study type: Interventional

Funder types: Other

Identifiers

NCT04576910

ZJCDC202002701

Details and patient eligibility

About

This study is to evaluate the immunogenicity and safety of Sabin IPV or bOPV, given as a booster vaccination in children aged 4 years who were previously immunised with different sequential immunization history by Sabin IPV and bOPV, and to observe the antibody persistence three years after different primary sequential immunization with Sabin IPV or bOPV at age 2, 3 and 4 months.

Full description

This is a continuous study of preliminary trial (Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: NCT03147560) . The investigators will follow up previous participants at age 4 years old with different primary sequential immunization schedules at age 2, 3 and 4 months: sIPV-bOPV-bOPV , sIPV-sIPV-bOPV , or sIPV-sIPV-sIPV, and give the 4th doses of polio vaccine with Sabin IPV or bOPV. A pre-vaccination blood sample is taken for polio antibody determinations. Sabin IPV will be administrated for participants in the previous Group 1 (sIPV-bOPV-bOPV), and Sabin IPV or bOPV will be given for participants in the previous Group 2 (sIPV-sIPV-bOPV) and Group 3 (sIPV-sIPV-sIPV) after they were randomly divided into two subgroups. At least two active surveillance visits, during which staff visited the participants s at home (on days 3 and 30) will required after vaccination to collect adverse reaction data. Parents or legal guardians were instructed to contact investigators if they observed any possible vaccine-related adverse events or important medical events (such as serious illness, physical disability, or death). The second blood sample will be collected 28-60 days after the booster vaccination. The investigators will asess the immunogenicity by seroconversion rate and seropositivity after the booster vaccination, and evaluate the antibody persistence using seropositive rate and GMT in participants before the booster vaccination. Safety will assessed with the occurrence of adverse events reported across the study groups.

Enrollment: 387 patients

Sex: All

Ages: 48 to 51 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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387 participants in 5 patient groups

Group A("Sabin IPV+ bOPV+ bOPV"+Sabin IPV)

Experimental group

Description:

Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 1 of preliminary study (NCT03147560).

Treatment:

Biological: vaccinated with Sabin IPV

Group B("Sabin IPV+ Sabin IPV+ bOPV"+bOPV)

Experimental group

Description:

Give the 4th doses of polio vaccine with bOPV for participants in the Group 2 of preliminary study (NCT03147560) after randomization.

Treatment:

Biological: vaccinated with bOPV

Group C("Sabin IPV+ Sabin IPV+ bOPV"+Sabin IPV)

Experimental group

Description:

Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 2 of preliminary study (NCT03147560) after randomization.

Treatment:

Biological: vaccinated with Sabin IPV

Group D("Sabin IPV+ Sabin IPV+ Sabin IPV"+bOPV)

Experimental group

Description:

Give the 4th doses of polio vaccine with bOPV for participants in the Group 3 of preliminary study (NCT03147560) after randomization.

Treatment:

Biological: vaccinated with bOPV

Group E("Sabin IPV+ Sabin IPV+ Sabin IPV"+Sabin IPV)

Experimental group

Description:

Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 3 of preliminary study (NCT03147560) after randomization.

Treatment:

Biological: vaccinated with Sabin IPV