The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)
NCT ID: NCT01056705
Last Updated: 2016-08-02
Study Results
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Basic Information
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COMPLETED
PHASE2
500 participants
INTERVENTIONAL
2009-07-31
2010-08-31
Brief Summary
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Detailed Description
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Oral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2 5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type 3 32DU.
This is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart respectively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Cohort 1: Experiment Infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections;
Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
Cohort 2: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections;
Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.
Cohort 3: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections;
Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.
Cohort 4: Experiment infants
Biological: Oral Poliomyelitis Vaccine (OPV).3x0.1ml oral;
Oral Poliomyelitis Vaccine
Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.
Cohort 5: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Salk strains). 3x0.5ml intramuscular injections;
Inactivated Poliomyelitis Vaccine (Salk strains).
3x0.5ml intramuscular injections, one month apart.
Interventions
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Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.
Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.
Oral Poliomyelitis Vaccine
Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.
Inactivated Poliomyelitis Vaccine (Salk strains).
3x0.5ml intramuscular injections, one month apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
* Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
* Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
* Axillary temperature ≤37℃.
Exclusion Criteria
* Low platelet or bleeding disorder do not allow vaccination into the muscle;
* Have damaged or lower immunological function;
* Received blood, plasma or immunoglobulin treatment since birth;
* Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
* Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
* Have serious anaphylaxis or high fever, convulsion during first dose;
* Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
* Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
* Vaccinated with any other vaccine（except DTP）;
* Stop observation determined by investigator owing to occurring serious adverse event;
60 Days
90 Days
ALL
Yes
Sponsors
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Guangxi Center for Disease Control and Prevention
OTHER_GOV
National Institute for the Control of Pharmaceutical and Biological Products, China
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Guoyang Liao
Head of Biologicals No.5
Principal Investigators
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Liao Guoyang, PHD
Role: PRINCIPAL_INVESTIGATOR
Institute of Medical Biology, Chinese Academy of Medical Sciences
Li Rongcheng, MD
Role: PRINCIPAL_INVESTIGATOR
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Li Changgui, PHD
Role: PRINCIPAL_INVESTIGATOR
National Institute for the Control of Pharmaceutical and Biological Products, China
Locations
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Pingle Center for Disease Control and Prevention
Pingle County, Guangxi, China
Countries
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References
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Sun M, Li C, Xu W, Liao G, Li R, Zhou J, Li Y, Cai W, Yan D, Che Y, Ying Z, Wang J, Yang H, Ma Y, Ma L, Ji G, Shi L, Jiang S, Li Q. Immune Serum From Sabin Inactivated Poliovirus Vaccine Immunization Neutralizes Multiple Individual Wild and Vaccine-Derived Polioviruses. Clin Infect Dis. 2017 May 15;64(10):1317-1325. doi: 10.1093/cid/cix110.
Liao G, Li R, Li C, Sun M, Li Y, Chu J, Jiang S, Li Q. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial. J Infect Dis. 2012 Jan 15;205(2):237-43. doi: 10.1093/infdis/jir723. Epub 2011 Dec 8.
Other Identifiers
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SFDA2007L02021
Identifier Type: OTHER
Identifier Source: secondary_id
imbcams-02
Identifier Type: -
Identifier Source: org_study_id
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