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

Primary Purpose

Polio, Vaccine Reaction

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
vaccinated with Sabin IPV
vaccinated with bOPV
Sponsored by
Zhejiang Provincial Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polio focused on measuring Immunogenicity, Antibody persistence, Safety, Sabin IPV, bOPV

Eligibility Criteria

48 Months - 51 Months (Child)All SexesAccepts 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.

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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)

Arm Description

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.

Outcomes

Primary Outcome Measures

Seroconversion rates of the booster vaccination
Defined as any positive antibody (titre ≥ 8) response in children who were seronegative prior to the vaccination, or at least a fourfold increase in type-specific antibody levels for children who had pre-existing positive antibodies
Persistence (tite rates) of antibodies against poliovirus 3 years after the primary 3 dose polio vaccine immunization
The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus 3 years after the primary immunization with different sequential immunization schedules using sIPV or bOPV
Seroprotection rates after the booster vaccination
The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus

Secondary Outcome Measures

Safety of the booster dose of polio vaccine immunization
the occurrence of adverse events for the booster dose of Polio vaccine administered at age 4 using Sabin IPV or bOPV
Antibody titers pesistence against poliovirus
Geometric Mean Titres (GMTs) or Median antibody titers for three poliovirus types
Antibody titers against poliovirus after the booster immunization
Geometric Mean Titres (GMTs) or Median antibody titers for three poliovirus types after the booster dose of Polio vaccine administered at age 4 using Sabin IPV or bOPV

Full Information

First Posted
September 18, 2020
Last Updated
March 3, 2022
Sponsor
Zhejiang Provincial Center for Disease Control and Prevention
Collaborators
China National Biotec Group Company ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04576910
Brief Title
Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China
Official Title
Immunogenicity and Safety of the Booster Dose of Polio Vaccine Immunization Using Sabin IPV or bOPV at Children Aged 4 Years With Different Three Sequential Schedules History by Sabin IPV or bOPV in China
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Provincial Center for Disease Control and Prevention
Collaborators
China National Biotec Group Company ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polio, Vaccine Reaction
Keywords
Immunogenicity, Antibody persistence, Safety, Sabin IPV, bOPV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
387 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A("Sabin IPV+ bOPV+ bOPV"+Sabin IPV)
Arm Type
Experimental
Arm Description
Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 1 of preliminary study (NCT03147560).
Arm Title
Group B("Sabin IPV+ Sabin IPV+ bOPV"+bOPV)
Arm Type
Experimental
Arm Description
Give the 4th doses of polio vaccine with bOPV for participants in the Group 2 of preliminary study (NCT03147560) after randomization.
Arm Title
Group C("Sabin IPV+ Sabin IPV+ bOPV"+Sabin IPV)
Arm Type
Experimental
Arm Description
Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 2 of preliminary study (NCT03147560) after randomization.
Arm Title
Group D("Sabin IPV+ Sabin IPV+ Sabin IPV"+bOPV)
Arm Type
Experimental
Arm Description
Give the 4th doses of polio vaccine with bOPV for participants in the Group 3 of preliminary study (NCT03147560) after randomization.
Arm Title
Group E("Sabin IPV+ Sabin IPV+ Sabin IPV"+Sabin IPV)
Arm Type
Experimental
Arm Description
Give the 4th doses of polio vaccine with Sabin IPV for participants in the Group 3 of preliminary study (NCT03147560) after randomization.
Intervention Type
Biological
Intervention Name(s)
vaccinated with Sabin IPV
Intervention Description
the 4th dose of polio vaccination
Intervention Type
Biological
Intervention Name(s)
vaccinated with bOPV
Intervention Description
the 4th dose of polio vaccination
Primary Outcome Measure Information:
Title
Seroconversion rates of the booster vaccination
Description
Defined as any positive antibody (titre ≥ 8) response in children who were seronegative prior to the vaccination, or at least a fourfold increase in type-specific antibody levels for children who had pre-existing positive antibodies
Time Frame
before and 28-60 days after the booster dose (4 years old) of polio vaccine
Title
Persistence (tite rates) of antibodies against poliovirus 3 years after the primary 3 dose polio vaccine immunization
Description
The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus 3 years after the primary immunization with different sequential immunization schedules using sIPV or bOPV
Time Frame
3 years after the primary three doses of polio immunization(before the booster vaccination )
Title
Seroprotection rates after the booster vaccination
Description
The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus
Time Frame
28-60 days after the booster dose (4 years old) of polio vaccine
Secondary Outcome Measure Information:
Title
Safety of the booster dose of polio vaccine immunization
Description
the occurrence of adverse events for the booster dose of Polio vaccine administered at age 4 using Sabin IPV or bOPV
Time Frame
30 days after the booster vaccination
Title
Antibody titers pesistence against poliovirus
Description
Geometric Mean Titres (GMTs) or Median antibody titers for three poliovirus types
Time Frame
3 years after the primary three doses of polio immunization(before the booster vaccination )
Title
Antibody titers against poliovirus after the booster immunization
Description
Geometric Mean Titres (GMTs) or Median antibody titers for three poliovirus types after the booster dose of Polio vaccine administered at age 4 using Sabin IPV or bOPV
Time Frame
28-60 days after the booster dose of polio vaccine given

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
51 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Chunan center for disease control and prevention
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Longyou Center for Disease Control and Prevention
City
Quzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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

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