A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.

Study Overview

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

Detailed Description

A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Shandong 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 (over 60 days and less than 90 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 (delivery before the 37th week of pregnancy).
2. Previous vaccination against polio.
3. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
4. History of polio.
5. History or family history of convulsions, seizures, encephalopathy, and neurological disorder.
6. History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine.
7. Individuals with immunodeficiency or receiving immunosuppression therapy.
8. Disturbance of coagulation diagnosed by doctor (e.g., coagulation factors deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder.
9. Known or suspected concomitant diseases include: respiratory disease, acute infection or active chronic disease, cardiovascular disease, liver and kidney disease, skin disease, mother with HIV infection.
10. Administration of blood or blood-related products or immunoglobulins (hepatitis B immunoglobulins is acceptable).
11. History of administration of live attenuated vaccines within 14 days.
12. History of administration of subunit or inactivated vaccines within 7 days.
13. Individuals with any acute diseases within 7 days, receiving antibiotics or antiviral therapy.
14. Fever within 3 days (Armpit temperature ≥38.0 ℃).
15. Use of any investigational product recently, or have any conditions that the investigator believes may affect the evaluation of the trial.

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; study group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants	Biological: sIPV+bOPV; 2+1 sequential" immunization program (sIPV-sIPV-bOPV)
Active Comparator: control group; control group: wIPV-wIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants	Biological: wIPV+bOPV; 2+1 sequential" immunization program (wIPV-wIPV-bOPV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody	Day 30 post full vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
GMT of poliovirus type I, type II and type III neutralizing antibody	Day 30 post full vaccination
GMI of poliovirus type I, type II and type III neutralizing antibody	Day 30 post full vaccination
The seropositive rates of poliovirus type I, type II and type III neutralizing antibody	Day 30 post full vaccination
The ratio of poliovirus type I, type II and type III neutralizing antibody titer ≥1:64	Day 30 post full vaccination
Incidence of adverse reactions/events	30 days after each dose of vaccination
Incidence of serious adverse events (SAE)	From the first immunization to 6 months after the last immunization

Collaborators and Investigators

• Sponsor: Beijing Minhai Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): April 12, 2024
• Study Completion (Actual): April 12, 2024

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: bOPV; sIPV; sequential immune
• 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: 2017L00935-2

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
• product manufactured in and exported from the U.S.: No