The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Phase 2/3 Clinical Trial to Assess the Safety and Immunogenicity of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)
* Biological: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live attenuated Poliomyelitis vaccine (human diploid cell)<br>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). | Biological: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)<br>* 6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).<br>* Other names: Poliomyelitis（Live）Vaccine(Human Diploid Cell),Oral;|
| Experimental: Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral<br>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). | Biological: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)<br>* 6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).<br>* Other names: Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral;|

What is the study measuring?
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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 | 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 . | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 30 days | 
| 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. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poliomyelitis, Vaccine, Safety, efficacy