Back to resultsThe Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
Primary Purpose
Poliomyelitis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Live attenuated Poliomyelitis vaccine (Human Diploid Cell)
Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)
Sponsored by
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Poliomyelitis, Vaccine, Safety, efficacy
Eligibility Criteria
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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Sites / Locations
- Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Live attenuated Poliomyelitis vaccine (human diploid cell)
Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated
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 .
Secondary Outcome Measures
The frequency of all the adverse events in vaccine group and placebo group
compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine groups.
Change of seroconversion from baseline to 3 months
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.
Full Information
NCT ID
NCT02231632
First Posted
August 1, 2014
Last Updated
October 7, 2023
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Guangxi Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02231632
Brief Title
The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
Official Title
Phase 2/3 Clinical Trial to Assess the Safety and Immunogenicity of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Guangxi Center for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Poliomyelitis, Vaccine, Safety, efficacy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Live attenuated Poliomyelitis vaccine (human diploid cell)
Arm Type
Experimental
Arm Description
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).
Arm Title
Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Live attenuated Poliomyelitis vaccine (Human Diploid Cell)
Other Intervention Name(s)
Poliomyelitis（Live）Vaccine(Human Diploid Cell),Oral
Intervention Description
6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
Intervention Type
Biological
Intervention Name(s)
Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)
Other Intervention Name(s)
Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral
Intervention Description
6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
Primary Outcome Measure Information:
Title
Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated
Description
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 .
Time Frame
up to 90 days
Secondary Outcome Measure Information:
Title
The frequency of all the adverse events in vaccine group and placebo group
Description
compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine groups.
Time Frame
up to 30 days
Title
Change of seroconversion from baseline to 3 months
Description
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.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qihan Li, Ph.D
Organizational Affiliation
Institude of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jingsi Yang
Organizational Affiliation
Institude of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rongcheng Li
Organizational Affiliation
Guangxi Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
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