Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
NCT ID: NCT03147560
Last Updated: 2019-09-12
Study Results
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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COMPLETED
PHASE4
528 participants
INTERVENTIONAL
2017-05-02
2017-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1
The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV.
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.
Group 2
The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV.
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.
Group 3
The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
60 Days
75 Days
ALL
No
Sponsors
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China National Biotec Group Company Limited
INDUSTRY
Zhejiang Provincial Center for Disease Control and Prevention
OTHER_GOV
Responsible Party
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Locations
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Chunan Center for Disease Control and Prevention
Hangzhou, Zhejiang, China
Longyou Center for Disease Control and Prevention
Quzhou, Zhejiang, China
Countries
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References
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He H, Wang Y, Deng X, Yue C, Tang X, Li Y, Liu Y, Yin Z, Zhang G, Chen Z, Xie S, Wen N, An Z, Chen Z, Wang H. Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial. Lancet Infect Dis. 2020 Sep;20(9):1071-1079. doi: 10.1016/S1473-3099(19)30738-8. Epub 2020 May 19.
Other Identifiers
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ZJCDC20170508
Identifier Type: -
Identifier Source: org_study_id
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