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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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 .
Sponsor: Chinese Academy of Medical Sciences

Current Primary Outcome: 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 ]

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 .


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The frequency of all the adverse events in vaccine group and placebo group [ Time Frame: up to 30 days ]
    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 [ Time Frame: up 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.


Original Secondary Outcome: Same as current

Information By: Chinese Academy of Medical Sciences

Dates:
Date Received: August 1, 2014
Date Started: January 2011
Date Completion:
Last Updated: September 1, 2014
Last Verified: September 2014