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

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

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

    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118

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.

-

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).
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:
  • Poliomyelitis(Live)Vaccine(Human Diploid Cell),Oral
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).
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:
  • Poliomyelitis(Live)Vaccine(Monkey Kidney Cell),Oral

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
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
Time Frame: up to 30 days
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
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.
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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