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Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Sponsored by
Institute of Medical Biology, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

2 Months - 3 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Disease prevention and control center of Shanghai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Arm Description

Primary 3-dose of sIPV and booster 1 dose of sIPV

Outcomes

Primary Outcome Measures

Safety monitoring
Active and passive monitoring for local and systemic adverse reactions

Secondary Outcome Measures

Full Information

First Posted
January 6, 2020
Last Updated
October 7, 2023
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Shanghai Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04220515
Brief Title
Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Official Title
Phase IV Safety Monitoring Study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
October 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Shanghai Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49731 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Arm Type
Experimental
Arm Description
Primary 3-dose of sIPV and booster 1 dose of sIPV
Intervention Type
Biological
Intervention Name(s)
Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Intervention Description
Type I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU
Primary Outcome Measure Information:
Title
Safety monitoring
Description
Active and passive monitoring for local and systemic adverse reactions
Time Frame
30 days post inoculation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Sun
Organizational Affiliation
Disease prevention and control center of Shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Disease prevention and control center of Shanghai
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participants do not agree to share the individual data.
Citations:
PubMed Identifier
33487470
Citation
Jiang R, Liu X, Sun X, Wang J, Huang Z, Li C, Li Z, Zhou J, Pu Y, Ying Z, Yin Q, Zhao Z, Zhang L, Lei J, Bao W, Jiang Y, Dou Y, Li J, Yang H, Cai W, Deng Y, Che Y, Shi L, Sun M. Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population. Vaccine. 2021 Mar 1;39(9):1463-1471. doi: 10.1016/j.vaccine.2021.01.027. Epub 2021 Jan 22.
Results Reference
derived

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Inactivated Poliomyelitis Vaccine Made From Sabin Strain

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