Clinical trial NCT04576910: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polio
Vaccine Reaction
Keywords: Immunogenicity
Antibody persistence
Safety
Sabin IPV
bOPV
Lead sponsor: Zhejiang Provincial Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
Collaborators: name: China National Biotec Group Company ltd
First posted: 2020-10-06
Enrollment: 387
Sex: ALL
Minimum age (years): 48
Maximum age (years): 51
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Seroconversion rates of the booster vaccination
timeFrame: before and 28-60 days after the booster dose (4 years old) of polio vaccine
measure: Persistence (tite rates) of antibodies against poliovirus 3 years after the primary 3 dose polio vaccine immunization
timeFrame: 3 years after the primary three doses of polio immunization(before the booster vaccination )
measure: Seroprotection rates after the booster vaccination
timeFrame: 28-60 days after the booster dose (4 years old) of polio vaccine
Secondary outcomes:
measure: Safety of the booster dose of polio vaccine immunization
timeFrame: 30 days after the booster vaccination
measure: Antibody titers pesistence against poliovirus
timeFrame: 3 years after the primary three doses of polio immunization(before the booster vaccination )
measure: Antibody titers against poliovirus after the booster immunization
timeFrame: 28-60 days after the booster dose of polio vaccine given
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Chunan center for disease control and prevention
state: Zhejiang
city: Quzhou
country: China
facility: Longyou Center for Disease Control and Prevention
state: Zhejiang
Study officials:
References: