Immunogenicity and Safety of Sabin-IPV Replacement Vaccination

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

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaccination

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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group 1

180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Sabin-IPV; 3rd: Sabin-IPV

Group Type EXPERIMENTAL

Inactivated Polio Vaccine

Intervention Type BIOLOGICAL

Inactivated Polio Vaccine at age of 2,3,4 months old, respectively

group 2

180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Salk-IPV; 3rd: Salk-IPV

Group Type ACTIVE_COMPARATOR

Inactivated Polio Vaccine

Intervention Type BIOLOGICAL

Inactivated Polio Vaccine at age of 2,3,4 months old, respectively

Interventions

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Inactivated Polio Vaccine

Inactivated Polio Vaccine at 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 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;

Minimum Eligible Age

60 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes