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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

NCT ID: NCT06752174

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2024-04-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Poliomyelitis

Keywords

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sIPV bOPV sequential immune

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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study group

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

Group Type EXPERIMENTAL

sIPV+bOPV

Intervention Type BIOLOGICAL

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

control group

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

Group Type ACTIVE_COMPARATOR

wIPV+bOPV

Intervention Type BIOLOGICAL

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

Interventions

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sIPV+bOPV

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

Intervention Type BIOLOGICAL

wIPV+bOPV

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Minhai Biotechnology Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shandong Provincial Center for Diseases Control and Prevention

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2017L00935-2

Identifier Type: -

Identifier Source: org_study_id