Clinical trial NCT03147560: Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
Official title: Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polio
Keywords: Immunogenicity
Safety
Sabin IPV
bOPV
Lead sponsor: Zhejiang Provincial Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
Collaborators: name: China National Biotec Group Company Limited
First posted: 2017-05-10
Enrollment: 528
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: seroconversion rate
timeFrame: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
Secondary outcomes:
measure: safety: rate of adverse events
timeFrame: At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
measure: neutralizing antibody titer
timeFrame: Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Chunan Center for Disease Control and Prevention
state: Zhejiang
city: Quzhou
country: China
facility: Longyou Center for Disease Control and Prevention
state: Zhejiang
Study officials:
References:
citation: 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.