Clinical trial NCT04054492: To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
Official title: A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccination
Reaction - Vaccine
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
name: Shaanxi Provincial Center for Disease Control and Prevention
name: Hubei Provincial Center for Disease Control and Prevention
name: Peking University
First posted: 2019-08-13
Enrollment: 604
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.

Detailed description: A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 groups.

Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.

Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.

Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

Blood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.

Eligibility criteria: Inclusion Criteria:

* subjects aged from 60 days to 89 days old at the date of recruitment;
* with informed consent signed by parent(s) or guardians;
* parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
* subjects did not receive any vaccination within 14 days;
* axillary temperature ≤37.0℃

Exclusion Criteria:

* allergic to any ingredient of vaccine or with allergy history to any vaccine;
* acute febrile disease or infectious disease;
* serious chronic diseases;
* any other factor that makes the investigator determines the subject is unsuitable for this study;

Primary outcomes:
measure: Seroconversion rates at both baseline and 30 days after the 3rd vaccination
timeFrame: 4 months
Secondary outcomes:
measure: Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination
timeFrame: 4 months
Other outcomes:
measure: the occurrence of adverse events
timeFrame: 6 months
Locations:
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
state: Inner Mongolia Autonomous Region
Study officials:
affiliation: Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
name: Shaohong Yan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yan S, Chen H, Zhang Z, Chang S, Xiao Y, Luo L, Zhang Z, Sun L, Chen X, Yang Y, Shi X, Guo Y, Sun Y, Li H, Li N, Han S, Ma M, Yang X. Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China. Vaccine. 2020 Sep 11;38(40):6274-6279. doi: 10.1016/j.vaccine.2020.07.042. Epub 2020 Jul 31.