Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

August 16, 2021 updated by: Sinovac Biotech Co., Ltd

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

1300

Phase

  • Phase 3

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

    • Yunnan
      • Honghe, Yunnan, China, 652399
        • Mile City Center for Disease Control and Prevention
      • Honghe, Yunnan, China, 661000
        • Gejiu County Center for Disease Control and Prevention
      • Wenshan, Yunnan, China, 663100
        • Yanshan County Center for Disease Control and Prevention
      • Wenshan, Yunnan, China, 663200
        • Qiubei County Center for Disease Control and Prevention

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

1 month to 2 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental Vaccine-lot 1
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
EXPERIMENTAL: Experimental Vaccine-lot 2
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
EXPERIMENTAL: Experimental Vaccine-lot 3
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
ACTIVE_COMPARATOR: Control Vaccine
Wild strain IPV (wIPV)manufactured by Sanofi Pasteur S.A.
Three doses control wIPV at the schedule of 2,3,4 months of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity index-Geometric mean titer of neutralizing antibody
Time Frame: The 30th day after the third dose vaccination
Micro-neutralization method will be used in the neutralizing antibody assay
The 30th day after the third dose vaccination
Immunogenicity index-Seroconversion rates of neutralizing antibody
Time Frame: The 30th day after the third dose vaccination
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.
The 30th day after the third dose vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity index-Seropositive rate of neutralizing antibody
Time Frame: The 30th day after the third dose vaccination
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.
The 30th day after the third dose vaccination
Immunogenicity index-Geometric mean ratio of neutralizing antibody
Time Frame: The 30th day after the third dose vaccination
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
The 30th day after the third dose vaccination
Safety index-Incidence of solicited adverse events
Time Frame: Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination
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.
Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination
Safety index-Incidence of unsolicited adverse events
Time Frame: Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination
Unsolicited adverse events refer to the unsolicited symptoms occur within day 0-7, and any symptoms occur out of that period
Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination
Safety index-Incidence of serious adverse events (SAEs)
Time Frame: From the beginning of vaccination to 30 days after the third dose vaccination
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.
From the beginning of vaccination to 30 days after the third dose vaccination

Collaborators and Investigators

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

May 11, 2020

Primary Completion (ACTUAL)

May 11, 2020

Study Completion (ACTUAL)

October 20, 2020

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (ACTUAL)

May 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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