Reaction - Vaccine, Vaccination
Conditions
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.
Interventions
BIOLOGICALSabin-IPV+bOPV+bOPV
202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
BIOLOGICALSabin-IPV+Sabin-IPV+bOPV
197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
BIOLOGICALSabin-IPV+Sabin-IPV+Sabin-IPV
205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively
Sponsors
Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
Shaanxi Provincial Center for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Peking University
China National Biotec Group Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Days to 89 Days
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rates at both baseline and 30 days after the 3rd vaccination | 4 months | Determine the seroconversion rates of poliovirus (types I,II,III）at both baseline and 30 days after the 3rd vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination | 4 months | Measure neutralizing antibody titers against poliovirus type I, II and III at both baseline and 30 days after the 3rd vaccination |
Other
| Measure | Time frame | Description |
|---|---|---|
| the occurrence of adverse events | 6 months | analyse the numbers and rates of participants who experience adverse events following immunization |
Countries
China
Outcome results
None listed