Vaccination
Conditions
Brief summary
This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.
Detailed description
It is required by China Food and Drug Administration (CFDA) that considering in the real situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aiming to demonstrate the safety and immunogenicity of the immunization schedule should be carried out. To be specific, the subjects were divided into 2 groups. Group 1 received Salk-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old. Group 2 received Salk-IPV+Salk-IPV+Salk-IPV respectively at the age of 2,3,4 months old. Blood sample was collected before vaccination and 30 days after the third dose of vaccination. 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 both immunization schedule will also been monitored.
Interventions
BIOLOGICALInactivated Polio Vaccine
Inactivated Polio Vaccine at age of 2,3,4 months old, respectively
Sponsors
Beijing Institute of Biological Products Co Ltd.
Beijing 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 vaccines 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 rate | 4 months | determine the seroconversion rate of both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody titers | 4 months | Measure neutralizing antibody titers against poliovirus type I, II and III |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of participants who experience adverse events | 6 months | analyse the number and rate of vaccine participants who have adverse events following immunization |
Countries
China
Outcome results
None listed