Sequential Vaccination of Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains From Different Manufacturers

April 12, 2024 updated by: Sinovac Biotech Co., Ltd

A Study to Evaluate the Immunogenicity and Safety of Sequential Vaccination Among Infants With Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains （Hereinafter as "sIPV") From Different Manufacturers.

To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Contact Backup

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (1) Healthy infants of ≤ 12 months of age;
  • (2) Can provide proof of legal identity;
  • (3) Have completed two doses of sIPV vaccination at Beijing Institute;
  • (4) Able to provide proof of sIPV vaccination;
  • (5) The participant's guardian can understand and agree to sign the informed consent form.

Exclusion Criteria:

  • (1) Known severe allergy to vaccines or vaccine components, such as urticaria, dyspnea, angioneurotic edema;
  • (2) Received immunoglobulins or other blood products, or plan to receive such treatment during the study;
  • (3) Received ≥14 days of immunosuppressive or other immunomodulatory therapy or cytotoxic therapy, or plan to receive such therapy during the study;
  • (4) Received another investigational vaccine within 28 days before receiving the study vaccine;
  • (5) Received a live attenuated vaccine within 14 days before receiving the trial vaccine;
  • (6) Received a subunit or inactivated vaccine within 7 days before receiving the trial vaccine;
  • (7) Acute exacerbation of various acute illnesses or chronic diseases within the last 7 days;
  • (8) Those who had a fever with an axillary temperature >37.0°C before receiving the study vaccine;
  • (9) Participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in the study.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
sIPV: Sinovac Biotech Co., Ltd., Beijing
Biological: sIPV
One dose of the experimental/control vaccine will be administered to 4-month-old infants who have already received two doses of sIPV from Beijing Institute of Biological Products Co., LTD.
Active Comparator: control group
sIPV: Beijing Institute of Biological Products Co., LTD.
Biological: sIPV
One dose of the experimental/control vaccine will be administered to 4-month-old infants who have already received two doses of sIPV from Beijing Institute of Biological Products Co., LTD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Increase (GMI)
Time Frame: 30 days
-The neutralizing antibody GMI against different types (Type I, II and III) at day 30 after vaccination;
30 days
Geometric Mean Titer (GMT)
Time Frame: 30 days
-The neutralizing antibody GMT against different types (Type I, II and III) at day 30 after vaccination;
30 days
Seropositivity rate
Time Frame: 30 days
-The seropositivity rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
30 days
Seroconversion rate
Time Frame: 30 days
-The seroconversion rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
30 days
Adverse reaction incidence
Time Frame: 30 days
-The incidence of adverse reaction within 30 days after vaccination;
30 days
Serious adverse events incidence
Time Frame: 30 days
-The incidence of serious adverse events within 30 days after vaccination.
30 days

Collaborators and Investigators

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

Sponsor

Sinovac Biotech Co., Ltd

Investigators

  • Principal Investigator: Lei Wang, Hubei Provincial Center for Disease Control and Prevention

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 (Estimated)

April 30, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-sIPV-4002

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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