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

NCT06346834 | Completed Phase 4

• 1 other identifier: PRO-sIPV-4002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

sIPV: Sinovac Biotech Co., Ltd., Beijing

Biological: sIPV

control group

ACTIVE COMPARATOR

sIPV: Beijing Institute of Biological Products Co., LTD.

Biological: sIPV

Interventions

sIPV BIOLOGICAL

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.

control group; experimental group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Disease Control and Prevention Center, Xiaonan District, Xiaogan City

Xiaogan, China

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Lei Wang

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: April 4, 2024
• Study Start: May 20, 2024
• Primary Completion: September 6, 2024
• Study Completion: December 6, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)