- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01510366
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV) (IPV)
The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Study Overview
Status
Conditions
Detailed Description
The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.
Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.
This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Guangxi
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Guilin, Guangxi, China, 530400
- Pingle Center for Disease Prevention and Control
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Nanning, Guangxi, China, 530400
- Bingyang Center for Disease Prevention and Control
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females, age from 60 days to 90 days;
- 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:
- Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
- 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.
Exclusion Criteria for doses 2 and 3
- Have serious anaphylaxis or high fever, convulsion during first dose;
- Have any circus of Exclusion Criteria after Eligible for study;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.
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Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
Other Names:
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Experimental: Cohort 2:
Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.
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Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Time Frame: fours year
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Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.
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fours year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Time Frame: One year
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Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination
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One year
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Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV
Time Frame: 30-60 days after third dose immunization
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One dose of tOPV was given after one month of third dose of IPV.
The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge.
And determine the excretion rates of polioviruses.
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30-60 days after third dose immunization
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yanping Li, MD, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- Principal Investigator: Changgui Li, PHD, National Institute for the Control of Pharmaceutical and Biological Products, China
- Principal Investigator: Guoyang Liao, PH.D, Institute of Medical Biology, Chinese Academy of Medical Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Neuromuscular Diseases
- Central Nervous System Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Myelitis
- Neuroinflammatory Diseases
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- IMBCAMS-03
- 2011L01484 (Other Identifier: China state food and drug adminstration)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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