To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV

China National Biotec Group (CNBG)

Status and phase: Completed; Phase 4

Conditions: Vaccination; Reaction - Vaccine

Treatments: Biological: Sabin-IPV+Sabin-IPV+bOPV; Biological: Sabin-IPV+bOPV+bOPV; Biological: Sabin-IPV+Sabin-IPV+Sabin-IPV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04054492

sIPV-2018XG-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 604 patients

Sex: All

Ages: 60 to 89 days old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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604 participants in 3 patient groups

sIPV+bOPV+bOPV

Experimental group

Description:

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

Treatment:

Biological: Sabin-IPV+bOPV+bOPV

sIPV+sIPV+bOPV

Active Comparator group

Description:

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

Treatment:

Biological: Sabin-IPV+Sabin-IPV+bOPV

sIPV+sIPV+sIPV

Active Comparator group

Description:

205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively

Treatment:

Biological: Sabin-IPV+Sabin-IPV+Sabin-IPV