Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

July 25, 2017 updated by: Sinovac Biotech Co., Ltd

A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants

The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
708

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221300
        • Pizhou City Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
  • Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
  • Proven legal identity;
  • Participants (≥ 18 years old), or guardians of the participants (< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
  • Complying with the requirement of the study protocol;
  • Axillary temperature ≤ 37.0 °C;

Exclusion Criteria:

  • Breast feeding, pregnant, or expected to conceive in the next 60 days;
  • History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
  • Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
  • Autoimmune disease or immunodeficiency/immunosuppressive;
  • serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
  • severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
  • History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
  • Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
  • Long term history of alcoholism or drug abuse;

  • Receipt of any of the following products:

    1. Any subunit or inactivated vaccine within the past 7 day;
    2. Any live attenuated vaccine within the past 14 days;
    3. Any other investigational medicine(s) within the past 30 days;
    4. Any blood product within the past 3 months;
    5. Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
  • Acute illness or acute exacerbation of chronic disease within the past 7 days;
  • Axillary temperature > 37.0 °C;
  • Infant participants with prior vaccination of poliovirus;
  • Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase I Adult Group - High dosage
  • Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
  • Intervention: Single-dose regimen of high dosage investigational sIPV
Biological: Single-dose regimen of high dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: Phase I Adult Group - Medium dosage
  • Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
  • Intervention: Single-dose regimen of medium dosage investigational sIPV
Biological: Single-dose regimen of medium dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: Phase I Child Group - High dosage
  • Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
  • Intervention: Single-dose regimen of high dosage investigational sIPV
Biological: Single-dose regimen of high dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: Phase I Child Group - Medium dosage
  • Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
  • Intervention: Single-dose regimen of medium dosage investigational sIPV
Biological: Single-dose regimen of medium dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: Phase I Infant Group - High dosage
  • Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
  • Intervention: Three-dose regimen of high dosage investigational sIPV
Biological: Three-dose regimen of high dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: Phase I Infant Group - Medium dosage
  • Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
  • Intervention: Three-dose regimen of medium dosage investigational sIPV
Biological: Three-dose regimen of medium dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: Phase I Infant Group - Low dosage
  • Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
  • Intervention: Three-dose regimen of low dosage investigational sIPV
Biological: Three-dose regimen of low dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: PhaseⅡExperimental Group - High dosage
  • Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
  • Intervention: Three-dose regimen of high dosage investigational sIPV
Biological: Three-dose regimen of high dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: PhaseⅡExperimental Group - Medium dosage
  • Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
  • Intervention: Three-dose regimen of medium dosage investigational sIPV
Biological: Three-dose regimen of medium dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Experimental: PhaseⅡExperimental Group - Low dosage
  • Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
  • Intervention: Three-dose regimen of low dosage investigational sIPV
Biological: Three-dose regimen of low dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Active Comparator: PhaseⅡControl Group -commercialized sIPV
  • Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
  • Intervention:Three-dose regimen of commercialized sIPV
Biological: Three-dose regimen of commercialized sIPV
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
Active Comparator: PhaseⅡ Control Group -commercialized IPV
  • Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
  • Intervention: Three-dose regimen of commercialized IPV
Biological: Three-dose regimen of commercialized IPV
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen
Time Frame: 90 days
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
90 days
The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
Time Frame: 90 days
GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
90 days
The geometric mean fold increase (GMI) of each group after three-dose regimen
Time Frame: 90 days
The GMI is the increase of post-immune GMT from pre-immune GMT.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidences of solicited adverse events (AEs) of each group in both phase I and II trials
Time Frame: 7 days
Solicited AEs occurred within 7 days after each injection will be collected.
7 days
The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials
Time Frame: 30 days
Unsolicited AEs occurred within 30 days after each injection will be collected.
30 days
The incidences of serious adverse events (SAEs) of each group in both phase I and II trials
Time Frame: 30 days
SAEs occurred within 30 days after each injection will be collected.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Biotech Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-sIPV-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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