- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04220515
Inactivated Poliomyelitis Vaccine Made From Sabin Strain
October 7, 2023 updated by: Institute of Medical Biology, Chinese Academy of Medical Sciences
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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Shanghai, China
- Disease prevention and control center of Shanghai
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-
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.
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170416
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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