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

NCT ID: NCT04576910

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2021-12-31

Brief Summary

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.

Detailed 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.

Conditions

Polio; Vaccine Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

vaccinated with Sabin IPV

Intervention Type: BIOLOGICAL

the 4th dose of polio vaccination

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

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

Group Type: EXPERIMENTAL

vaccinated with bOPV

Intervention Type: BIOLOGICAL

the 4th dose of polio vaccination

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

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

Group Type: EXPERIMENTAL

vaccinated with Sabin IPV

Intervention Type: BIOLOGICAL

the 4th dose of polio vaccination

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

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

Group Type: EXPERIMENTAL

vaccinated with bOPV

Intervention Type: BIOLOGICAL

the 4th dose of polio vaccination

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 3 of preliminary study (NCT03147560) after randomization.

Group Type: EXPERIMENTAL

vaccinated with Sabin IPV

Intervention Type: BIOLOGICAL

the 4th dose of polio vaccination

Interventions

vaccinated with Sabin IPV

the 4th dose of polio vaccination

Intervention Type: BIOLOGICAL

vaccinated with bOPV

the 4th dose of polio vaccination

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 48 Months
• Maximum Eligible Age: 51 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China National Biotec Group Company ltd

UNKNOWN

Sponsor Role: collaborator

Zhejiang Provincial Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chunan center for disease control and prevention

Hangzhou, Zhejiang, China

Longyou Center for Disease Control and Prevention

Quzhou, Zhejiang, China

Countries

China

References

Tang X, Xiao Y, Deng X, Zhou Y, Chen H, Yan R, Zhu Y, Wang S, Wang H, Zhu X, Luo L, Liu Y, Yin Z, Zhang G, Chen Z, Jiang J, Yang X, He H. Immuno-persistence of the different primary polio vaccine schedules and immunogenicity of the booster dose by sabin inactivated or bivalent oral poliovirus vaccine in children aged 4 years: an open-label, randomised, controlled phase 4 trial in China. Lancet Reg Health West Pac. 2023 Mar 17;34:100725. doi: 10.1016/j.lanwpc.2023.100725. eCollection 2023 May.

Reference Type: DERIVED

PMID: 37283972 (View on PubMed)

Other Identifiers

ZJCDC202002701

Identifier Type: -

Identifier Source: org_study_id