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Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization

NCT ID: NCT04618783

Last Updated: 2020-11-06

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

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-20

Study Completion Date

2020-01-10

Brief Summary

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This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.

Detailed Description

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This study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was selected and sent to China Center for Disease Control and Prevention (CDC) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1).

All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.

Conditions

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Poliomyelitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low-dosage experimental group

Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses

Group Type EXPERIMENTAL

Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses

Intervention Type BIOLOGICAL

Antigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Medium-dosage experimental group

Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses

Group Type EXPERIMENTAL

Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses

Intervention Type BIOLOGICAL

Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

High-dosage experimental group

Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses

Group Type EXPERIMENTAL

Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses

Intervention Type BIOLOGICAL

Antigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Control wIPV group

Three doses of control wIPV, vaccinated within one-month interval between doses

Group Type ACTIVE_COMPARATOR

Three doses of control wIPV, vaccinated within one-month interval between doses

Intervention Type BIOLOGICAL

Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Control sIPV group

Three doses of control sIPV, vaccinated within one-month interval between doses

Group Type ACTIVE_COMPARATOR

Three doses of control sIPV, vaccinated within one-month interval between doses

Intervention Type BIOLOGICAL

Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Interventions

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Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses

Antigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Intervention Type BIOLOGICAL

Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses

Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Intervention Type BIOLOGICAL

Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses

Antigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Intervention Type BIOLOGICAL

Three doses of control wIPV, vaccinated within one-month interval between doses

Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Intervention Type BIOLOGICAL

Three doses of control sIPV, vaccinated within one-month interval between doses

Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants of the already finished phase 2 clinical trial;
* Subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial;
* Provide written informed consent.

Exclusion Criteria

* None.
Minimum Eligible Age

2 Months

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuemei Hu, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Control and Prevention

Locations

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Pizhou Center for Disease Control and Prevention

Pizhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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PRO-sIPV-1001-1

Identifier Type: -

Identifier Source: org_study_id