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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

604 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-06-12

Brief Summary

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

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Detailed Description

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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.

Conditions

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Vaccination Reaction - Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sIPV+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

Group Type EXPERIMENTAL

Sabin-IPV+bOPV+bOPV

Intervention Type BIOLOGICAL

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

sIPV+sIPV+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

Group Type ACTIVE_COMPARATOR

Sabin-IPV+Sabin-IPV+bOPV

Intervention Type BIOLOGICAL

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

sIPV+sIPV+sIPV

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

Group Type ACTIVE_COMPARATOR

Sabin-IPV+Sabin-IPV+Sabin-IPV

Intervention Type BIOLOGICAL

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

Interventions

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Sabin-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

Intervention Type BIOLOGICAL

Sabin-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

Intervention Type BIOLOGICAL

Sabin-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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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;

Minimum Eligible Age

60 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes