- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02231632
The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
October 7, 2023 updated by: Institute of Medical Biology, Chinese Academy of Medical Sciences
Phase 2/3 Clinical Trial to Assess the Safety and Immunogenicity of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)
Study Overview
Status
Completed
Conditions
Detailed Description
Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis(Live)Vaccine (Monkey Kidney Cell),Oral .
After its safety been proved in phase 1 clinical trail evaluation , the phase 2/3 trail was started in Guangxi Province, China during 2011-2012.
The purpose of this trial is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Yunnan
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Kunming, Yunnan, China, 650118
- Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 4 months (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:Only subjects fulfilling all of the following criteria will be eligible for the study:
- People aged from 2 months to 4 months old.
- The subjects or subjects' guardians are able to understand and sign the informed consent
- The subjects or subjects' guardians allow to comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
- The subjects have signed informed consent already
Exclusion Criteria:The subjects have never been vaccinated with any Poliomyelitis Vaccine.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Live attenuated Poliomyelitis vaccine (human diploid cell)
6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50,typeⅡnot lower than 5.0 lgCCID50,type Ⅲ not lower than 5.5 lgCCID50).
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6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
Other Names:
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Experimental: Poliomyelitis(Live)Vaccine(Monkey Kidney Cell),Oral
6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50,typeⅡnot lower than 5.0 lgCCID50,type Ⅲ not lower than 5.5 lgCCID50).
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6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated
Time Frame: up to 90 days
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20 children aged 4 years old and 20 infants aged 2 months were vaccinated with 3 dose of Live attenuated Poliomyelitis vaccine (human diploid cell).
Their faeces on day 0,7,30,60 and 90 were collected and incubated in L20B and RD cells for 2 generations, in order to separate and amplify poliovirus I-III Sabin strains in faeces of study objects .
Extract total viral RNA from the culture supernatants and detect virogene VP1 through RT-PCR and sequencing ,in order to test the genovariation of vaccinal I-III Sabin strains in faeces after vaccinated .
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up to 90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The frequency of all the adverse events in vaccine group and placebo group
Time Frame: up to 30 days
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compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine groups.
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up to 30 days
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Change of seroconversion from baseline to 3 months
Time Frame: up to 3 months
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Randomly chose 600 infants respectively from two study arms, get 2.5ml of the blood on the first day and 3 months during vaccination .Reciprocal antibody titers of at least 1:8, the lowest detectable titer, is considered to indicate seropositivity with regards to the presence of poliovirus neutralizing antibodies.
Seroconversion is defined as either seronegative participants (<1:8 titers) who become seropositive (≥1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32.
Chi-square tests will be used to test the statistical significance among seroconversion rates across study arms.
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up to 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Qihan Li, Ph.D, Institude of Medical Biology, Chinese Academy of Medical Sciences
- Study Director: Jingsi Yang, Institude of Medical Biology, Chinese Academy of Medical Sciences
- Principal Investigator: Rongcheng Li, Guangxi Provincial Center for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 1, 2014
First Submitted That Met QC Criteria
September 1, 2014
First Posted (Estimated)
September 4, 2014
Study Record Updates
Last Update Posted (Estimated)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 7, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
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
- Yangjingsi2014
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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