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Hand, Foot and Mouth DiseasePhase 4NCT03873740

Immunogenicity and Safety of Two Different Commercial EV71 Vaccines

A Phase 4 study testing EV71 inactived vaccine（Vero cells） and EV71 inactived vaccine（Human diploid cells） 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 sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months. 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 inactived vaccine（Vero cells） and EV71 inactived vaccine（Human diploid cells）
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
6 Nov 2018to 23 Jan 2019
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 volunteer aged 6-35 months;
  • Proven legal identity;
  • Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study.

Who cannot join

  • Prior vaccination with EV71 vaccine;
  • 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;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
  • Autoimmune diseases or immunodeficiency/immunosuppression;
  • Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis;
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  • History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
  • Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months;
  • Receipt of any of the following products:
  • Blood product within 3 months prior to study entry;
  • Any live attenuated vaccine within 14 days prior to study entry;
  • Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  • Any other study drugs within 30 days prior to study entry;
  • Acute disease or acute stage of chronic disease within 7 days prior to study entry;
  • Axillary temperature > 37.0℃;
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Rushan City Center for Disease Control and Prevention

    Xiacun, Shandong, 264500

Other trials in China

About this study

Official title: A Opened，Randomized and Controlled Trial to Evaluate the Immunity and Safety of Sequential Vaccination of Two Different Commercial EV71 Inactived Vaccines in Healthy Infants Aged 6-35 Months

The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.

Read the detailed description

This study is a opened,randomized and controlled phase Ⅳ clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months. EV71 inactived vaccines(Vero cells）was manufactured by Sinovac Biotech Co., Ltd and EV71 inactived vaccines(Human diploid cells）was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.300 infants aged between 6-35 months will be randomly assigned into experimental group in the ratio 1:1:1:1.The experimental group 1 received two doses EV71 inactived vaccines(Vero cells）on day 0 and 30. The experimental group 2 received two doses EV71 inactived vaccines (Human diploid cells）on day 0 and 30. The experimental group 3 received one dose EV71 inactived vaccines (Vero cells）on day 0 and one dose EV71 inactived vaccines (Human diploid cells）on day 30.The experimental group 4 received one dose EV71 inactived vaccines (Human diploid cells）on day 0 and one dose EV71 inactived vaccines (Vero cells）on day 30. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the EV71 neutralizing antibody detection prior to vaccination and 30 days after the 2nd dose vaccination.

Being tested
EV71 inactived vaccine（Vero cells）, EV71 inactived vaccine（Human diploid cells）
Keywords
Inactivated Enterovirus Type 71 (EV71) Vaccine, Sequential vaccination, Immunity, Safety
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 inactived vaccine（Vero cells）Biological

    The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.

  • EV71 inactived vaccine（Human diploid cells）Biological

    The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Study groups in NCT03873740
Study groupRoleWhat they receive
Single vaccine group AExperimentalThis group receive two doses injection of EV71 inactived vaccines(Vero cells) on Day 0 and 30, and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.
Receives: Biological: EV71 inactived vaccine（Vero cells）
Single vaccine group BExperimentalThis group receive two doses injection of EV71 inactived vaccines(human diploid cells)on Day 0 and 30, two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Receives: Biological: EV71 inactived vaccine（Human diploid cells）
Sequential vaccination group AExperimentalOne dose injection of EV71 inactived vaccines(Vero cells) on Day 0，following one dose of EV71 vaccine(EV71 inactived vaccines(human diploid cells), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
Receives: Biological: EV71 inactived vaccine（Vero cells）; Biological: EV71 inactived vaccine（Human diploid cells）
Sequential vaccination group BExperimentalOne dose injection of EV71 inactived vaccines(human diploid cells)on Day 0，following one does of EV71 vaccine(Sinovac Vaccine Technology Co., Ltd), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
Receives: Biological: EV71 inactived vaccine（Vero cells）; Biological: EV71 inactived vaccine（Human diploid cells）

What is being measured

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

  1. The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8.

    Subjects whose pre-immune EV71 antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune EV71 antibody level ≥ 4 folds are considered seroconverted

    Measured: 30 days after two doses

Secondary outcomes (6)

  1. The incidences of adverse reactions after each does

    After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. Unsolicited adverse events on day 0-30 were also reported. Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE).

    Measured: 0-30 days after each dose

  2. The incidence of solicited local and general adverse events after each does

    After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE).

    Measured: 0-7 days after each dose

  3. Incidence of serious adverse events (SAEs) during the period of safety monitoring

    Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose.

    Measured: 0-30 days after each dose

  4. EV71 neutralizing antibody positive rate of each group after two doses.

    Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive.

    Measured: 30 days after two doses

  5. The Geometric mean titer (GMT) of the EV71 neutralizing antibody

    The GMT 30 days of each group after two doses.

    Measured: 30 days after two doses

  6. The geometric mean fold increase (GMI) of the EV71 neutralizing antibody

    The GMI 30 days of each group after two doses.

    Measured: 30 days after two doses

Timeline

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

  1. First posted13 Mar 2019
  2. Study start6 Nov 2018
  3. Primary completion21 Jan 2019
  4. Study completion23 Jan 2019

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03873740
Sponsor's protocol ID
EV71-SD-2018-01
Status last verified
Mar 2019
First submitted
2 Mar 2019
Last updated
29 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu Q, Cao Q, Yang W, Liu X, Liu H, Tian X, Li J, Fang X, Jia N, Zeng G, Xu A. Interchangeability of two Enterovirus 71 inactivated vaccines in Chinese children: A phase IV, open-label, and randomized controlled trial. Vaccine. 2020 Mar 10;38(12):2671-2677. doi: 10.1016/j.vaccine.2020.02.013. Epub 2020 Feb 14.

    PubMed 32067817

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EV71 inactived vaccine（Vero cells） and EV71 inactived vaccine（Human diploid cells） 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 17 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 29 Jul 2021. 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 rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8. (time frame: 30 days after two doses). 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 NCT03873740, 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 29 Jul 2021.

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