Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Phase IV Safety Monitoring Study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

This study includes both active and passive safety monitoring in large pupulations for the phase IV safety monitoring study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV).

Study Overview

Detailed Description

For active safety monitoring in expanding populations, a total of 20,019 participants in Shanghai CDC have been enrolled in accordance with GCP for close safety monitoring for immediate adverse events and telephone or visiting follow-up (30 min, 24h, 3d, 7d, 14d, 30d) For passive safety monitoring in larger populations, the purpose is to observe rare adverse events after primary and booster immunization with sIPV by passive safety surveillance via AEFI monitoring system in Shanghai CDC. A total of 29,712 infants have been enrolled, and the adverse events of the participates have been collected via AEFI monitoring system and evaluated after 3-dose sIPV for primary immunization.

Study Type

Interventional

Enrollment (Actual)

49731

Phase

  • Phase 4

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

      • Shanghai, China
        • Disease prevention and control center of Shanghai

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

Ages Eligible for Study

2 months to 3 months (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy infants of 2 months of age
  • The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
  • Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
  • Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
  • Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
  • Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
  • Axillary temperature ≤37℃

Exclusion Criteria:

  • Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
  • Patients with fever or acute disease.
  • Have thrombocytopenia or hemorrhagic diseases
  • Patients undergoing immunosuppressive therapy or immunodeficiency
  • Have uncontrolled epilepsy or other progressive neurological disorders
  • Other situations that the investigator consider as non-eligible

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Primary 3-dose of sIPV and booster 1 dose of sIPV
Type I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety monitoring
Time Frame: 30 days post inoculation
Active and passive monitoring for local and systemic adverse reactions
30 days post inoculation

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Xiaodong Sun, Disease prevention and control center of Shanghai

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.

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 (Actual)

February 8, 2018

Primary Completion (Actual)

August 8, 2019

Study Completion (Actual)

October 14, 2019

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants do not agree to share the individual data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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