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

NCT07297186 | Completed Phase 3

• 1 other identifier: 2017L00935
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies

  30 days after the primary immunization

Study Arms (2)

study group

EXPERIMENTAL

600 participants

Biological: sIPV

control group

ACTIVE COMPARATOR

600 participants

Biological: wIPV

Interventions

sIPV BIOLOGICAL

sIPVs were developed by Biominhai (Beijing Minhai Biotechnology Co. Ltd.)

study group

wIPV BIOLOGICAL

wIPVs were developed by Sanofi Pasteur

control group

Eligibility Criteria

• Age: 60 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• preterm birth (gestational age \< 37 weeks);
• the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
• had a history of poliomyelitis;
• had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders;
• had known hypersensitivity to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination;
• had immunodeficiency or receipt of immunosuppressive therapy;
• diagnosed coagulation disorders (including factor deficiencies, coagulopathies, platelet abnormalities) or evidence of significant bruising/bleeding diathesis;
• 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;
• occurrence of fever (axillary temperature ≥ 38.0 °C) within the 3 days preceding enrollment;
• had acute illness requiring systemic antibiotic or antiviral treatment within the 7 days preceding enrollment;
• administration of blood products within the 3 months preceding enrollment;
• had receipt of any live attenuated vaccine within the 14 days preceding enrollment;
• had receipt of any inactivated or subunit vaccine within the 7 days preceding enrollment;
• 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.

Sponsors & Collaborators

• Beijing Minhai Biotechnology Co., Ltd: lead

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, 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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: August 21, 2017
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)