Phase III Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell)

A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell) Conducted in Healthy Infants Aged Two Months.

The study aimed to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine in infants aged two months (60~89 days).

Study Overview

• Status: Completed
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: sIPV; Biological: wIPV

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Provincial Center for Diseases Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy permanent residents aged 2 months (60~89 days);
2. Infant's legal guardians agree to sign the informed consent forms voluntarily;
3. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
4. Armpit temperature ≤ 37.0 ℃

Exclusion Criteria:

1. preterm birth (gestational age < 37 weeks);
2. the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
3. had a history of poliomyelitis;
4. had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders;
5. had known hypersensitivity to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination;
6. had immunodeficiency or receipt of immunosuppressive therapy;
7. diagnosed coagulation disorders (including factor deficiencies, coagulopathies, platelet abnormalities) or evidence of significant bruising/bleeding diathesis;
8. had known or investigator-suspected concurrent acute or active chronic diseases (including respiratory, cardiovascular, hepatic, renal, or dermatological conditions) or acute infection, or maternal HIV infection;
9. occurrence of fever (axillary temperature ≥ 38.0 °C) within the 3 days preceding enrollment;
10. had acute illness requiring systemic antibiotic or antiviral treatment within the 7 days preceding enrollment;
11. administration of blood products within the 3 months preceding enrollment;
12. had receipt of any live attenuated vaccine within the 14 days preceding enrollment;
13. had receipt of any inactivated or subunit vaccine within the 7 days preceding enrollment;
14. had recent administration of any other experimental product and any other condition deemed by the investigator as potentially interfering with the assessment of trial outcomes.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; 600 participants	Biological: sIPV; sIPVs were developed by Biominhai (Beijing Minhai Biotechnology Co. Ltd.)
Active Comparator: control group; 600 participants	Biological: wIPV; wIPVs were developed by Sanofi Pasteur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies	30 days after the primary immunization

Collaborators and Investigators

• Sponsor: Beijing Minhai Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 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: 2017L00935

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