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Completed

NCT Number: NCT02231632

The Immunogenicity and Safety 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)

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Key information

Conditions

Poliomyelitis Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

2 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Kunming, Yunnan, 650118, China

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Live attenuated Poliomyelitis vaccine (Human Diploid Cell)

Biological

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

Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)

Biological

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

Primary outcomes

  1. 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 .

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Other

Collaborators

  • Guangxi Center for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 4, 2014
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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