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

NCT06752174 | Completed Phase 3

• 1 other identifier: 2017L00935-2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Poliomyelitis

Keywords

sIPV; bOPV; sequential immune

Outcome Measures

Primary Outcomes (1)

• The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody

  Day 30 post full vaccination

Secondary Outcomes (6)

• 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

Study Arms (2)

study group

EXPERIMENTAL

study group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants

Biological: sIPV+bOPV

control group

ACTIVE COMPARATOR

control group: wIPV-wIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants

Biological: wIPV+bOPV

Interventions

sIPV+bOPV BIOLOGICAL

2+1 sequential" immunization program (sIPV-sIPV-bOPV)

study group

wIPV+bOPV BIOLOGICAL

2+1 sequential" immunization program (wIPV-wIPV-bOPV)

control group

Eligibility Criteria

• Age: 60 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy permanent residents aged 2 months (over 60 days and less than 90 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 (delivery before the 37th week of pregnancy).
• Previous vaccination against polio.
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
• History of polio.
• History or family history of convulsions, seizures, encephalopathy, and neurological disorder.
• History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine.
• Individuals with immunodeficiency or receiving immunosuppression therapy.
• Disturbance of coagulation diagnosed by doctor (e.g., coagulation factors deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder.
• 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.
• Administration of blood or blood-related products or immunoglobulins (hepatitis B immunoglobulins is acceptable).
• History of administration of live attenuated vaccines within 14 days.
• History of administration of subunit or inactivated vaccines within 7 days.
• Individuals with any acute diseases within 7 days, receiving antibiotics or antiviral therapy.
• Fever within 3 days (Armpit temperature ≥38.0 ℃).
• Use of any investigational product recently, or have any conditions that the investigator believes may affect the evaluation of the trial.

Sponsors & Collaborators

• Beijing Minhai Biotechnology Co., Ltd: lead

Study Sites (1)

Shandong Provincial Center for Diseases Control and Prevention

Jinan, Shandong, 250014, 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 12, 2024
• First Posted: December 30, 2024
• Study Start: March 8, 2023
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)