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PoliomyelitisPhase 2/3NCT02231632

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

A Phase 2/3 study testing Live attenuated Poliomyelitis vaccine (Human Diploid Cell) and Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell) in people with Poliomyelitis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell) Read more about this study

Who is it for?
Ages 2 to 4 monthsHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
Live attenuated Poliomyelitis vaccine (Human Diploid Cell) and Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteChina
Study dates
Jan 2011to Aug 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 4 months
  • All sexes
  • Healthy volunteers accepted
  • Child

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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Trial locations and contacts

1 site in 1 country.

China1 site

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

    Kunming, Yunnan, 650118

Other trials in China

About this study

Official title: 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)

Read the 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 .

Conditions
Poliomyelitis
Being tested
Live attenuated Poliomyelitis vaccine (Human Diploid Cell), Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)
Keywords
Poliomyelitis, Vaccine, Safety, efficacy
Medical subject headings
Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Live attenuated Poliomyelitis vaccine (Human Diploid Cell)Biological

    Also called Poliomyelitis（Live）Vaccine(Human Diploid Cell),Oral

    6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).

  • Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)Biological

    Also called Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral

    6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).

Study groups in NCT02231632
Study groupRoleWhat they receive
Live attenuated Poliomyelitis vaccine (human diploid cell)Experimental6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).
Receives: Biological: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)
Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),OralExperimental6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).
Receives: Biological: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 .

    Measured: up to 90 days

Secondary outcomes (2)

  1. 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.

    Measured: up to 30 days

  2. 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.

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2014 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02231632
Sponsor's protocol ID
Yangjingsi2014
Status last verified
Oct 2023
First submitted
1 Aug 2014
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Live attenuated Poliomyelitis vaccine (Human Diploid Cell) and Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell) in people with Poliomyelitis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

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