Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
NCT ID: NCT04386707
Last Updated: 2021-08-18
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
PHASE3
1300 participants
INTERVENTIONAL
2020-05-11
2020-10-20
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
DOUBLE
Study Groups
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Experimental Vaccine-lot 1
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Experimental Vaccine-lot 2
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Experimental Vaccine-lot 3
sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Control Vaccine
Wild strain IPV (wIPV）manufactured by Sanofi Pasteur S.A.
Three doses control wIPV at the schedule of 2,3,4 months of age
Three doses control wIPV at the schedule of 2,3,4 months of age
Interventions
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Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Three doses control wIPV at the schedule of 2,3,4 months of age
Three doses control wIPV at the schedule of 2,3,4 months of age
Eligibility Criteria
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Inclusion Criteria
* legal identity;
* Informed consent form has been signed by guardians.
Exclusion Criteria
* Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc.;
* Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
* Autoimmune disease or immunodeficiency/immunosuppression;
* Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders;
* Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
* Receipt of immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis);
* Receipt of blood products prior to this study;
* Receipt of other study drugs within 30 days prior to this study;
* Receipt of live attenuated vaccines within 14 days prior to this study;
* Receipt of subunit or inactivated vaccines within 7 days prior to this study;
* Acute diseases or acute exacerbation of chronic diseases within recent 7 days;
* Axillary temperature \>37.0℃;
* Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
60 Days
89 Days
ALL
Yes
Sponsors
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Sinovac Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yan Zheng, Master
Role: PRINCIPAL_INVESTIGATOR
Yunnan Provincial Center for Disease Control and Prevention
Locations
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Yanshan County Center for Disease Control and Prevention
Wenshan, Yunnan, China
Qiubei County Center for Disease Control and Prevention
Wenshan, Yunnan, China
Mile City Center for Disease Control and Prevention
Yisa, Yunnan, China
Gejiu County Center for Disease Control and Prevention
Yisa, Yunnan, China
Countries
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Other Identifiers
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PRO-sIPV-3002
Identifier Type: -
Identifier Source: org_study_id
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