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

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

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.

Study Overview

• Status: Completed
• Conditions: Vaccine Reaction; Polio
• Intervention / Treatment: Biological: vaccinated with Sabin IPV; Biological: vaccinated with bOPV

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.

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Chunan Center for Disease Control and Prevention
    • Quzhou, Zhejiang, China
      • longyou Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Biological: vaccinated with Sabin IPV; the 4th dose of polio vaccination
Experimental: 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.	Biological: vaccinated with bOPV; the 4th dose of polio vaccination
Experimental: 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.	Biological: vaccinated with Sabin IPV; the 4th dose of polio vaccination
Experimental: 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.	Biological: vaccinated with bOPV; the 4th dose of polio vaccination
Experimental: 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.	Biological: vaccinated with Sabin IPV; the 4th dose of polio vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days after the booster vaccination
Antibody titers pesistence against poliovirus	Geometric Mean Titres (GMTs) or Median antibody titers for three poliovirus types	3 years after the primary three doses of polio immunization(before the booster vaccination )
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	28-60 days after the booster dose of polio vaccine given

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; bOPV; Antibody persistence; Sabin IPV
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: ZJCDC202002701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No