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Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Three doses control wIPV at the schedule of 2,3,4 months of age
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

60 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infants aged 60-89 days;
  • legal identity;
  • Informed consent form has been signed by guardians.

Exclusion Criteria:

  • Vaccination history of polio vaccine;
  • Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc.;
  • Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
  • Autoimmune disease or immunodeficiency/immunosuppression;
  • Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders;
  • Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
  • Receipt of immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis);
  • Receipt of blood products prior to this study;
  • Receipt of other study drugs within 30 days prior to this study;
  • Receipt of live attenuated vaccines within 14 days prior to this study;
  • Receipt of subunit or inactivated vaccines within 7 days prior to this study;
  • Acute diseases or acute exacerbation of chronic diseases within recent 7 days;
  • Axillary temperature >37.0℃;
  • Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.

Sites / Locations

  • Mile City Center for Disease Control and Prevention
  • Gejiu County Center for Disease Control and Prevention
  • Yanshan County Center for Disease Control and Prevention
  • Qiubei County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Experimental Vaccine-lot 1

Experimental Vaccine-lot 2

Experimental Vaccine-lot 3

Control Vaccine

Arm Description

sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.

sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.

sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.

Wild strain IPV (wIPV）manufactured by Sanofi Pasteur S.A.

Outcomes

Primary Outcome Measures

Immunogenicity index-Geometric mean titer of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay
Immunogenicity index-Seroconversion rates of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8. Seroconversion (1:8) is defined as a change from seronegative (<1:8) to seropositive (≥1:8) or a 4-fold increase from baseline titers if seropositive.

Secondary Outcome Measures

Immunogenicity index-Seropositive rate of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8.
Immunogenicity index-Geometric mean ratio of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Geometric mean ratio of neutralizing antibody titer after vaccination divided by that before vaccination
Safety index-Incidence of solicited adverse events
Solicited adverse events refer to the adverse events occur within day 0-7 after each dose vaccination with the solicited symptoms including injection-site induration, redness, swelling, rashes, or pruritus, and fever, allergic reactions, abnormal activity level, loss of appetite, nausea, vomiting and diarrhea.
Safety index-Incidence of unsolicited adverse events
Unsolicited adverse events refer to the unsolicited symptoms occur within day 0-7, and any symptoms occur out of that period
Safety index-Incidence of serious adverse events (SAEs)
SAEs refers to the events occur in the process of clinical trial which may need hospitalization, prolongation of hospitalization time, disability, dysfunction, be life-threatening or death or lead to congenital malformation.

Full Information

First Posted
May 8, 2020
Last Updated
August 16, 2021
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04386707
Brief Title
Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
Official Title
A Randomized, Double-blinded, Controlled Clinical Trial to Evaluate Lot Consistency, Immunogenicity and Safety of Sabin Inactivated Polio Vaccine (Vero Cell) in 2-month-old Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
May 11, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.
Detailed Description
This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Vaccine-lot 1
Arm Type
Experimental
Arm Description
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Arm Title
Experimental Vaccine-lot 2
Arm Type
Experimental
Arm Description
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Arm Title
Experimental Vaccine-lot 3
Arm Type
Experimental
Arm Description
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Arm Title
Control Vaccine
Arm Type
Active Comparator
Arm Description
Wild strain IPV (wIPV）manufactured by Sanofi Pasteur S.A.
Intervention Type
Biological
Intervention Name(s)
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Intervention Description
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Intervention Type
Biological
Intervention Name(s)
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Intervention Description
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Intervention Type
Biological
Intervention Name(s)
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Intervention Description
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Intervention Type
Biological
Intervention Name(s)
Three doses control wIPV at the schedule of 2,3,4 months of age
Intervention Description
Three doses control wIPV at the schedule of 2,3,4 months of age
Primary Outcome Measure Information:
Title
Immunogenicity index-Geometric mean titer of neutralizing antibody
Description
Micro-neutralization method will be used in the neutralizing antibody assay
Time Frame
The 30th day after the third dose vaccination
Title
Immunogenicity index-Seroconversion rates of neutralizing antibody
Description
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8. Seroconversion (1:8) is defined as a change from seronegative (<1:8) to seropositive (≥1:8) or a 4-fold increase from baseline titers if seropositive.
Time Frame
The 30th day after the third dose vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity index-Seropositive rate of neutralizing antibody
Description
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8.
Time Frame
The 30th day after the third dose vaccination
Title
Immunogenicity index-Geometric mean ratio of neutralizing antibody
Description
Micro-neutralization method will be used in the neutralizing antibody assay; Geometric mean ratio of neutralizing antibody titer after vaccination divided by that before vaccination
Time Frame
The 30th day after the third dose vaccination
Title
Safety index-Incidence of solicited adverse events
Description
Solicited adverse events refer to the adverse events occur within day 0-7 after each dose vaccination with the solicited symptoms including injection-site induration, redness, swelling, rashes, or pruritus, and fever, allergic reactions, abnormal activity level, loss of appetite, nausea, vomiting and diarrhea.
Time Frame
Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination
Title
Safety index-Incidence of unsolicited adverse events
Description
Unsolicited adverse events refer to the unsolicited symptoms occur within day 0-7, and any symptoms occur out of that period
Time Frame
Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination
Title
Safety index-Incidence of serious adverse events (SAEs)
Description
SAEs refers to the events occur in the process of clinical trial which may need hospitalization, prolongation of hospitalization time, disability, dysfunction, be life-threatening or death or lead to congenital malformation.
Time Frame
From the beginning of vaccination to 30 days after the third dose vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infants aged 60-89 days; legal identity; Informed consent form has been signed by guardians. Exclusion Criteria: Vaccination history of polio vaccine; Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc.; Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.; Autoimmune disease or immunodeficiency/immunosuppression; Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders; Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors; Receipt of immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis); Receipt of blood products prior to this study; Receipt of other study drugs within 30 days prior to this study; Receipt of live attenuated vaccines within 14 days prior to this study; Receipt of subunit or inactivated vaccines within 7 days prior to this study; Acute diseases or acute exacerbation of chronic diseases within recent 7 days; Axillary temperature >37.0℃; Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zheng, Master
Organizational Affiliation
Yunnan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mile City Center for Disease Control and Prevention
City
Honghe
State/Province
Yunnan
ZIP/Postal Code
652399
Country
China
Facility Name
Gejiu County Center for Disease Control and Prevention
City
Honghe
State/Province
Yunnan
ZIP/Postal Code
661000
Country
China
Facility Name
Yanshan County Center for Disease Control and Prevention
City
Wenshan
State/Province
Yunnan
ZIP/Postal Code
663100
Country
China
Facility Name
Qiubei County Center for Disease Control and Prevention
City
Wenshan
State/Province
Yunnan
ZIP/Postal Code
663200
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

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