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The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV) (IPV)

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Salk strains)
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 focused on measuring Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis

Eligibility Criteria

60 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females, age from 60 days to 90 days;
  • Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
  • Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
  • Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
  • Axillary temperature ≤37℃.

Exclusion Criteria:

  • Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
  • Low platelet or bleeding disorder do not allow vaccination into the muscle;
  • Have damaged or lower immunological function;
  • Received blood, plasma or immunoglobulin treatment since birth;
  • Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
  • Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.

Exclusion Criteria for doses 2 and 3

  • Have serious anaphylaxis or high fever, convulsion during first dose;
  • Have any circus of Exclusion Criteria after Eligible for study;
  • Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
  • Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
  • Vaccinated with any other vaccine（except DTP）;
  • Stop observation determined by investigator owing to occurring serious adverse event.

Sites / Locations

  • Pingle Center for Disease Prevention and Control
  • Bingyang Center for Disease Prevention and Control

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2:

Arm Description

Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.

Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.

Outcomes

Primary Outcome Measures

The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.

Secondary Outcome Measures

The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination
Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV
One dose of tOPV was given after one month of third dose of IPV. The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge. And determine the excretion rates of polioviruses.

Full Information

First Posted
January 6, 2012
Last Updated
October 8, 2023
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Guangxi Center for Disease Control and Prevention, National Institute for the Control of Pharmaceutical and Biological Products, China
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1. Study Identification

Unique Protocol Identification Number
NCT01510366
Brief Title
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)
Acronym
IPV
Official Title
The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Guangxi Center for Disease Control and Prevention, National Institute for the Control of Pharmaceutical and Biological Products, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
Detailed Description
The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose. Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU. This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.
Arm Title
Cohort 2:
Arm Type
Experimental
Arm Description
Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.
Intervention Type
Biological
Intervention Name(s)
Inactivated Poliomyelitis Vaccine (Sabin strains)
Other Intervention Name(s)
Sabin IPV
Intervention Description
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
Intervention Type
Biological
Intervention Name(s)
Inactivated Poliomyelitis Vaccine (Salk strains)
Other Intervention Name(s)
Salk IPV or cIPV
Intervention Description
Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.
Primary Outcome Measure Information:
Title
The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Description
Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.
Time Frame
fours year
Secondary Outcome Measure Information:
Title
The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Description
Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination
Time Frame
One year
Title
Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV
Description
One dose of tOPV was given after one month of third dose of IPV. The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge. And determine the excretion rates of polioviruses.
Time Frame
30-60 days after third dose immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females, age from 60 days to 90 days; Adults, parent(s) or guardians are able to understand and sign informed consent for participation; Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days; Axillary temperature ≤37℃. Exclusion Criteria: Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy; Low platelet or bleeding disorder do not allow vaccination into the muscle; Have damaged or lower immunological function; Received blood, plasma or immunoglobulin treatment since birth; Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome ); Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV. Exclusion Criteria for doses 2 and 3 Have serious anaphylaxis or high fever, convulsion during first dose; Have any circus of Exclusion Criteria after Eligible for study; Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria; Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents; Vaccinated with any other vaccine（except DTP）; Stop observation determined by investigator owing to occurring serious adverse event.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoyang Liao, PH.D
Organizational Affiliation
Institute of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanping Li, MD
Organizational Affiliation
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Changgui Li, PHD
Organizational Affiliation
National Institute for the Control of Pharmaceutical and Biological Products, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pingle Center for Disease Prevention and Control
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
530400
Country
China
Facility Name
Bingyang Center for Disease Prevention and Control
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530400
Country
China

12. IPD Sharing Statement

Links:
URL
http://imbcams.ac.cn/Index.html
Description
Home page of Institute of Medical Biology, Chinese Academy of Medical Sciences

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The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)

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