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

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: Completed
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: sIPV

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 (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Xiaogan, China
    • Disease Control and Prevention Center, Xiaonan District, Xiaogan City

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Lei Wang, Hubei Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Actual): September 6, 2024
• Study Completion (Actual): December 6, 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 (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Infections; RNA Virus Infections; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Central Nervous System Infections; Myelitis; Poliomyelitis
• 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