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AzTrials

PolioPhase 4NCT04576910

Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China

A Phase 4 study testing vaccinated with Sabin IPV and vaccinated with bOPV in people with Polio and Vaccine Reaction, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites 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

This study is to evaluate the immunogenicity and safety of Sabin IPV or bOPV, given as a booster vaccination in children aged 4 years who were previously immunised with different sequential immunization history by Sabin IPV and bOPV, and to observe the antibody persistence three years after different primary… Read more about this study

Who is it for?
Ages 48 to 51 monthsHealthy volunteers can take part
Conditions the study is for
Polio, Vaccine Reaction
What is being tested?
vaccinated with Sabin IPV and vaccinated with bOPV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
387 participants
Where
2 sitesChina
Study dates
5 Nov 2020to 31 Dec 2021
Phase
Phase 4
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 48 to 51 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Participants aged ≥48 months to ≤ 51 months from preliminary study (NCT03147560) with sequential immunization history by Sabin IPV and bOPV.
  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
  • ≥ 14 days interval between the last vaccination.
  • Body temperature ≤ 37.2℃.

Who cannot join

  • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
  • Known allergy to any constituent of the vaccine.
  • Had 4 doses vaccination record of polio vaccine.
  • Known impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin .
  • Received non-specific immunoglobulin within 1 month.
  • An acute illness with fever (temperature ≥ 37.3℃) or any infectious diseases.
  • Patients with a well-diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications for injection.
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Chunan center for disease control and prevention

    Hangzhou, Zhejiang

  • Longyou Center for Disease Control and Prevention

    Quzhou, Zhejiang

Other trials in China

About this study

Official title: Immunogenicity and Safety of the Booster Dose of Polio Vaccine Immunization Using Sabin IPV or bOPV at Children Aged 4 Years With Different Three Sequential Schedules History by Sabin IPV or bOPV in China

This study is to evaluate the immunogenicity and safety of Sabin IPV or bOPV, given as a booster vaccination in children aged 4 years who were previously immunised with different sequential immunization history by Sabin IPV and bOPV, and to observe the antibody persistence three years after different primary sequential immunization with Sabin IPV or bOPV at age 2, 3 and 4 months.

Read the detailed description

This is a continuous study of preliminary trial (Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: NCT03147560) . The investigators will follow up previous participants at age 4 years old with different primary sequential immunization schedules at age 2, 3 and 4 months: sIPV-bOPV-bOPV , sIPV-sIPV-bOPV , or sIPV-sIPV-sIPV, and give the 4th doses of polio vaccine with Sabin IPV or bOPV. A pre-vaccination blood sample is taken for polio antibody determinations. Sabin IPV will be administrated for participants in the previous Group 1 (sIPV-bOPV-bOPV), and Sabin IPV or bOPV will be given for participants in the previous Group 2 (sIPV-sIPV-bOPV) and Group 3 (sIPV-sIPV-sIPV) after they were randomly divided into two subgroups. At least two active surveillance visits, during which staff visited the participants s at home (on days 3 and 30) will required after vaccination to collect adverse reaction data. Parents or legal guardians were instructed to contact investigators if they observed any possible vaccine-related adverse events or important medical events (such as serious illness, physical disability, or death). The second blood sample will be collected 28-60 days after the booster vaccination. The investigators will asess the immunogenicity by seroconversion rate and seropositivity after the booster vaccination, and evaluate the antibody persistence using seropositive rate and GMT in participants before the booster vaccination. Safety will assessed with the occurrence of adverse events reported across the study groups.

Being tested
vaccinated with Sabin IPV, vaccinated with bOPV
Keywords
Immunogenicity, Antibody persistence, Safety, Sabin IPV, bOPV
Medical subject headings
Poliomyelitis

What participants receive

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

  • vaccinated with Sabin IPVBiological

    the 4th dose of polio vaccination

  • vaccinated with bOPVBiological

    the 4th dose of polio vaccination

Study groups in NCT04576910
Study groupRoleWhat they receive
Group A("Sabin IPV+ bOPV+ bOPV"+Sabin IPV)ExperimentalGive the 4th doses of polio vaccine with Sabin IPV for participants in the Group 1 of preliminary study (NCT03147560).
Receives: Biological: vaccinated with Sabin IPV
Group B("Sabin IPV+ Sabin IPV+ bOPV"+bOPV)ExperimentalGive the 4th doses of polio vaccine with bOPV for participants in the Group 2 of preliminary study (NCT03147560) after randomization.
Receives: Biological: vaccinated with bOPV
Group C("Sabin IPV+ Sabin IPV+ bOPV"+Sabin IPV)ExperimentalGive the 4th doses of polio vaccine with Sabin IPV for participants in the Group 2 of preliminary study (NCT03147560) after randomization.
Receives: Biological: vaccinated with Sabin IPV
Group D("Sabin IPV+ Sabin IPV+ Sabin IPV"+bOPV)ExperimentalGive the 4th doses of polio vaccine with bOPV for participants in the Group 3 of preliminary study (NCT03147560) after randomization.
Receives: Biological: vaccinated with bOPV
Group E("Sabin IPV+ Sabin IPV+ Sabin IPV"+Sabin IPV)ExperimentalGive the 4th doses of polio vaccine with Sabin IPV for participants in the Group 3 of preliminary study (NCT03147560) after randomization.
Receives: Biological: vaccinated with Sabin IPV

What is being measured

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

  1. Seroconversion rates of the booster vaccination

    Defined as any positive antibody (titre ≥ 8) response in children who were seronegative prior to the vaccination, or at least a fourfold increase in type-specific antibody levels for children who had pre-existing positive antibodies

    Measured: before and 28-60 days after the booster dose (4 years old) of polio vaccine

  2. Persistence (tite rates) of antibodies against poliovirus 3 years after the primary 3 dose polio vaccine immunization

    The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus 3 years after the primary immunization with different sequential immunization schedules using sIPV or bOPV

    Measured: 3 years after the primary three doses of polio immunization(before the booster vaccination )

  3. Seroprotection rates after the booster vaccination

    The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus

    Measured: 28-60 days after the booster dose (4 years old) of polio vaccine

Secondary outcomes (3)

  1. Safety of the booster dose of polio vaccine immunization

    the occurrence of adverse events for the booster dose of Polio vaccine administered at age 4 using Sabin IPV or bOPV

    Measured: 30 days after the booster vaccination

  2. Antibody titers pesistence against poliovirus

    Geometric Mean Titres (GMTs) or Median antibody titers for three poliovirus types

    Measured: 3 years after the primary three doses of polio immunization(before the booster vaccination )

  3. Antibody titers against poliovirus after the booster immunization

    Geometric Mean Titres (GMTs) or Median antibody titers for three poliovirus types after the booster dose of Polio vaccine administered at age 4 using Sabin IPV or bOPV

    Measured: 28-60 days after the booster dose of polio vaccine given

Timeline

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

  1. First posted6 Oct 2020
  2. Study start5 Nov 2020
  3. Primary completion30 Jun 2021
  4. Study completion31 Dec 2021

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04576910
Sponsor's protocol ID
ZJCDC202002701
Status last verified
Mar 2022
First submitted
18 Sep 2020
Last updated
7 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tang X, Xiao Y, Deng X, Zhou Y, Chen H, Yan R, Zhu Y, Wang S, Wang H, Zhu X, Luo L, Liu Y, Yin Z, Zhang G, Chen Z, Jiang J, Yang X, He H. Immuno-persistence of the different primary polio vaccine schedules and immunogenicity of the booster dose by sabin inactivated or bivalent oral poliovirus vaccine in children aged 4 years: an open-label, randomised, controlled phase 4 trial in China. Lancet Reg Health West Pac. 2023 Mar 17;34:100725. doi: 10.1016/j.lanwpc.2023.100725. eCollection 2023 May.

    PubMed 37283972

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing vaccinated with Sabin IPV and vaccinated with bOPV in people with Polio and Vaccine Reaction, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites in China.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. 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 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Seroconversion rates of the booster vaccination (time frame: before and 28-60 days after the booster dose (4 years old) of polio vaccine). The study lists 3 primary outcomes in all. 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 NCT04576910, which also lists 1 linked publication.

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 7 Mar 2022.

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