- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03147560
Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
September 10, 2019 updated by: Zhejiang Provincial Center for Disease Control and Prevention
The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
528
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China
- Chunan Center for Disease Control and Prevention
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Quzhou, Zhejiang, China
- longyou Center for Disease Control and Prevention
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- Participant is aged ≥ 60 days to ≤ 75 days.
- Participant without preventive inoculation of polio vaccine and previous history of Polio.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Body temperature ≤ 37.5℃.
Exclusion Criteria:
- Known allergy to any constituent of the vaccine.
- Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
- Known bleeding disorder.
- Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
- Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
- An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial.
- Participation in any other intervention clinical trial.
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV.
|
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose.
sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
|
Experimental: Group 2
The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV.
|
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose.
sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
|
Experimental: Group 3
The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV.
|
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose.
sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
seroconversion rate
Time Frame: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
|
any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies.
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seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety: rate of adverse events
Time Frame: At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
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the rate of adverse events.
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At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
|
neutralizing antibody titer
Time Frame: Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.
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Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2017
Primary Completion (Actual)
December 30, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
May 8, 2017
First Submitted That Met QC Criteria
May 9, 2017
First Posted (Actual)
May 10, 2017
Study Record Updates
Last Update Posted (Actual)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ZJCDC20170508
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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