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Completed

NCT Number: NCT07297186

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

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).

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Key information

Age range

60 day–89 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 ℃

Exclusion criteria

  • 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.

Treatment and study plan

sIPV

Biological

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

wIPV

Biological

wIPVs were developed by Sanofi Pasteur

Primary outcomes

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

    Time frame: 30 days after the primary immunization

Sponsors and collaborators

Lead sponsor

Beijing Minhai Biotechnology Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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