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Hand, Foot and Mouth DiseasePhase 4NCT03278132

Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine

A Phase 4 study testing EV71 vaccine in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd 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 study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination Read more about this study

Who is it for?
Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for
Hand, Foot and Mouth Disease
What is being tested?
EV71 vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
16 Jul 2017to 15 Sep 2017
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 6 to 35 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy volunteers aged 6-35 months old
  • Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
  • Proven legal identity

Who cannot join

  • For subjects with any of the following conditions, vaccination should not be administrated:
  • History of hand foot and mouth disease
  • Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, pain, etc
  • Severe chronic diseases
  • Thrombocytopenia or hemorrhagic disease
  • Immunodeficiency disease or receipt of immunosuppressant treatment
Show all 21Show fewer
  • Uncontrolled epilepsy or progressive neurological disorders(e.g. Guillain-Barre syndrome)
  • Acute disease or acute stage of chronic disease prior to the study entry
  • History of thyroidectomy, thyroid disease within 12 months prior to the study entry
  • Asplenia or functional asplenia
  • Axillary temperature >37.0 ℃
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the judgment of investigators
  • Subjects with any of the following conditions are forbidden to continue the 2nd dose of vaccination:
  • Any serious adverse event that has a causal relationship with the investigated vaccine
  • Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination
  • Any confirmed or suspected autoimmune disease or immunodeficiency disease (e.g., HIV infection)
  • Other reactions (including severe pain, severe swelling, severe activity limitation, persistent hyperthermia, severe headache or other systemic or local reactions)determined by the investigators
  • For subjects suffering from acute disease or acute stage of chronic disease , whether to continue vaccination depends on themselves
  • Subjects with the following conditions may receive vaccination in delayed time or withdraw from the study depending on the judgment of investigator
  • Acute disease (moderate or severe disease with or without fever) in case of vaccination
  • Axillary temperature > 37.0 °C

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shangyu District Center for Disease Control and Prevention

    Shaoxing, Zhejiang, 312300

Other trials in China

About this study

Official title: A Phase IV Open-labelled, Single-centered, Stratified-randomized Clinical Trial in Zhejiang Province to Evaluate the Safety and Immunogenicity of EV71 Vaccine Developed by Sinovac Biotech Co., Ltd.

The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination

Read the detailed description

This study is an open-labelled, single-centered, stratified-randomized, phase IV clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine (developed by Sinovac Biotech Co., Ltd.) in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different times after vaccination. The enrolled subjects in this study receive two doses of EV71 vaccine with 1-month interval between doses. To evaluate safety of the vaccine, subjects will be observed for 30 days after the injection for the potential adverse events. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the neutralizing antibody detection prior to vaccination, 10/20/30 days after the 1st dose and 30 days after the 2nd dose vaccination. All subjects will receive blood sampling for three times. Subjects will be randomly assigned to receive blood sampling at 10/20/30 days after 1st dose injection, with a ratio of 1: 1: 1.

Being tested
EV71 vaccine
Keywords
Inactivated Enterovirus Type 71 (EV71) Vaccine, Safety, Immunogenicity, Infant
Medical subject headings
Hand, Foot and Mouth Disease

What participants receive

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

  • EV71 vaccineBiological

    Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.

Study groups in NCT03278132
Study groupRoleWhat they receive
EV71 vaccine & blood sampling (0, 10,60)ExperimentalThis group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 10, and 60 respectively for EV71 neutralizing antibody detection.
Receives: Biological: EV71 vaccine
EV71 vaccine & blood sampling (0, 20,60)ExperimentalThis group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 20, and 60 respectively for EV71 neutralizing antibody detection.
Receives: Biological: EV71 vaccine
EV71 vaccine& blood sampling (0, 30, 60)ExperimentalThis group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 30, and 60 respectively for EV71 neutralizing antibody detection.
Receives: Biological: EV71 vaccine

What is being measured

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

  1. The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination

    Immunogenicity indicator

    Measured: 30 days

Secondary outcomes (6)

  1. The seroconversion rate of EV71 neutralizing antibody 10, 20 and 30 days after the first dose vaccination

    Immunogenicity indicator

    Measured: 10,20,and 30 days

  2. The seropositive rate of EV71 neutralizing antibody 10, 20, 30, and 60 days after the first dose vaccination

    Immunogenicity indicator

    Measured: 10, 20,30,and 60 days

  3. GMT and GMT increase fold of EV71 neutralizing antibody 10,20,30,and 60 days after the first dose vaccination

    Immunogenicity indicator

    Measured: 10,20，30，and 60 days

  4. Incidence of unsolicited local or systemic adverse events within 3 days after each dose

    Safety indicator

    Measured: 3 days

  5. Incidence of unsolicited adverse events within 30 days after each dose

    Safety indicator

    Measured: 30 days

  6. Incidence of the serious adverse events within 60 days after the first dose vaccination

    Safety indicator

    Measured: 60 days

Timeline

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

  1. First posted11 Sep 2017
  2. Study start16 Jul 2017
  3. Primary completion15 Sep 2017
  4. Study completion15 Sep 2017

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03278132
Sponsor's protocol ID
PRO-EV71-4011
Status last verified
Dec 2018
First submitted
7 Sep 2017
Last updated
2 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang S, Zeng J, Zhang X, Gan Z, Fan J, Chen Y, Liang Z, Hu X, Zeng G, Lv H. Short-term dynamic changes in neutralizing antibodies against enterovirus 71 after vaccination. Hum Vaccin Immunother. 2020 Jul 2;16(7):1595-1601. doi: 10.1080/21645515.2020.1711678. Epub 2020 Jan 24.

    PubMed 31977278

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EV71 vaccine in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd 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?

The sponsor lists 3 inclusion and 21 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 2 Jan 2019. 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 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?

The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination (time frame: 30 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 NCT03278132, 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 2 Jan 2019.

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