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

NCT04576910 | Completed Phase 4

• 1 other identifier: ZJCDC202002701
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 2

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.

Conditions

Polio; Vaccine Reaction

Keywords

Immunogenicity; Antibody persistence; Safety; Sabin IPV; bOPV

Outcome Measures

Primary Outcomes (3)

• 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

  before and 28-60 days after the booster dose (4 years old) of polio vaccine

• 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

  3 years after the primary three doses of polio immunization(before the booster vaccination )

• Seroprotection rates after the booster vaccination

  The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus

  28-60 days after the booster dose (4 years old) of polio vaccine

Secondary Outcomes (3)

• Safety of the booster dose of polio vaccine immunization

  30 days after the booster vaccination

• Antibody titers pesistence against poliovirus

  3 years after the primary three doses of polio immunization(before the booster vaccination )

• Antibody titers against poliovirus after the booster immunization

  28-60 days after the booster dose of polio vaccine given

Study Arms (5)

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

EXPERIMENTAL

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

Biological: vaccinated with Sabin IPV

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

EXPERIMENTAL

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

Biological: vaccinated with bOPV

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

EXPERIMENTAL

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

Biological: vaccinated with Sabin IPV

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

EXPERIMENTAL

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

Biological: vaccinated with bOPV

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

EXPERIMENTAL

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

Biological: vaccinated with Sabin IPV

Interventions

vaccinated with Sabin IPV BIOLOGICAL

the 4th dose of polio vaccination

Group A("Sabin IPV+ bOPV+ bOPV"+Sabin IPV); Group C("Sabin IPV+ Sabin IPV+ bOPV"+Sabin IPV); Group E("Sabin IPV+ Sabin IPV+ Sabin IPV"+Sabin IPV)

vaccinated with bOPV BIOLOGICAL

the 4th dose of polio vaccination

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

Eligibility Criteria

• Age: 48 Months - 51 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial Center for Disease Control and Prevention: lead
• China National Biotec Group Company ltd: collaborator

Study Sites (2)

Chunan center for disease control and prevention

Hangzhou, Zhejiang, China

Location

Longyou Center for Disease Control and Prevention

Quzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 37283972 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 6, 2020
• Study Start: November 5, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-03

Locations

CN (2)