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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250014
- Shandong Provincial Center for Diseases Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 ℃
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: study group
study group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants
|
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
|
2+1 sequential" immunization program (wIPV-wIPV-bOPV)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody
Time Frame: Day 30 post full vaccination
|
Day 30 post full vaccination
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
GMT of poliovirus type I, type II and type III neutralizing antibody
Time Frame: Day 30 post full vaccination
|
Day 30 post full vaccination
|
|
GMI of poliovirus type I, type II and type III neutralizing antibody
Time Frame: Day 30 post full vaccination
|
Day 30 post full vaccination
|
|
The seropositive rates of poliovirus type I, type II and type III neutralizing antibody
Time Frame: Day 30 post full vaccination
|
Day 30 post full vaccination
|
|
The ratio of poliovirus type I, type II and type III neutralizing antibody titer ≥1:64
Time Frame: Day 30 post full vaccination
|
Day 30 post full vaccination
|
|
Incidence of adverse reactions/events
Time Frame: 30 days after each dose of vaccination
|
30 days after each dose of vaccination
|
|
Incidence of serious adverse events (SAE)
Time Frame: From the first immunization to 6 months after the last immunization
|
From the first immunization to 6 months after the last immunization
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2017L00935-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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