Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
1 other identifier
interventional
528
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2017
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2017
CompletedFirst Submitted
Initial submission to the registry
May 8, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2017
CompletedSeptember 12, 2019
September 1, 2019
8 months
May 8, 2017
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
seroconversion rate
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.
seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
Secondary Outcomes (2)
safety: rate of adverse events
At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
neutralizing antibody titer
Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.
Study Arms (3)
Group 1
EXPERIMENTALThe sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV.
Group 2
EXPERIMENTALThe sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV.
Group 3
EXPERIMENTALThe sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV.
Interventions
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.
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.
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
You may qualify if:
- 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℃.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chunan Center for Disease Control and Prevention
Hangzhou, Zhejiang, China
Longyou Center for Disease Control and Prevention
Quzhou, Zhejiang, China
Related Publications (1)
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.
PMID: 32442523DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2017
First Posted
May 10, 2017
Study Start
May 2, 2017
Primary Completion
December 30, 2017
Study Completion
December 30, 2017
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share