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

NCT ID: NCT07297186

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2023-04-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

study group

600 participants

Group Type: EXPERIMENTAL

sIPV

Intervention Type: BIOLOGICAL

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

control group

600 participants

Group Type: ACTIVE_COMPARATOR

wIPV

Intervention Type: BIOLOGICAL

wIPVs were developed by Sanofi Pasteur

Interventions

sIPV

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

Intervention Type: BIOLOGICAL

wIPV

wIPVs were developed by Sanofi Pasteur

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 89 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Minhai Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2017L00935

Identifier Type: -

Identifier Source: org_study_id