AzTrials
AzTrials

Hand, Foot and Mouth DiseasePhase 4NCT03274102

Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines

A Phase 4 study testing Concomitant administration of EV71 vaccine with EPI vaccines, Single injection of EPI vaccine and EV71 Vaccine only 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
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine. Read more about this study

Who is it for?
Ages 6 to 6 monthsHealthy volunteers can take part
Conditions the study is for
Hand, Foot and Mouth Disease
What is being tested?
Concomitant administration of EV71 vaccine with EPI vaccines, Single injection of EPI vaccine and EV71 Vaccine only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
1 siteChina
Study dates
22 Apr 2017to 1 Nov 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 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy volunteers aged 6 months
  • Finished two doses of vaccination (0,1 month) of hepatitis B vaccine prior to study entry
  • Proven legal identity
  • 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

Who cannot join

  • Finished all the three doses vaccination (0,1,6 month) of hepatitis B vaccine prior to study entry
  • Prior vaccination of meningococcal polysaccharide vaccine
  • Prior vaccination of EV71 vaccine
  • Unable to receive vaccination on both arms
  • History of hand foot and mouth disease
  • Previously tested HBsAg positive
Show all 28Show fewer
  • Mother of the subject had been previously tested HBsAg positive
  • History of asthma; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc
  • Congenital malformation, developmental disorders, genetic defects
  • Autoimmune disease or immunodeficiency/immunosuppressive
  • Severe nervous system disease or mental illness
  • 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) within 6 month prior to study entry
  • Receipt of blood product (e.g., immunoglobulin) within 3 months prior to study entry
  • Receipt of any other investigational medicine(s) within 30 days prior to study entry
  • Receipt of any live attenuated vaccine within 14 days prior to study entry
  • Receipt of any subunit vaccine or inactivated vaccine within 7 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 judgement of investigators
  • Subjects with one of the following 1 to 3 conditions are forbidden to continue vaccination, while the other study steps could be carried out based on the judgement of investigator; for subjects with one of the following 4 to 5 conditions, whether to continue vaccination are determined by the investigator; for subjects with one of the following 6 to 7 conditions, vaccination may be delayed in the time window specified in the study:
  • Any serious adverse event that has a causal relationship with the investigated vaccine (except the group II)
  • Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination, except the group II )
  • Any confirmed or suspected autoimmune disease or immunodeficiency disease (e.g., HIV infection)
  • New chronic diseases or acute stage of chronic diseases
  • Other reactions (including severe pain, severe swelling, severe activity limitation, persistent hyperthermia, severe headache or other systemic or local reactions) determined by the investigators
  • Acute diseases (moderate or severe diseases with or without fever)
  • Axillary temperature> 37.0 ℃

Trial locations and contacts

1 site in 1 country.

China1 site

  • Dongguan Municipal Center for Disease Control and Prevention

    Dongguan, Guangdong, 523129

Other trials in China

About this study

Official title: A Randomized, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Recombinant Hepatitis B Vaccine/Group A Meningococcal Polysaccharide Vaccine

The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine.

Read the detailed description

This study is an open-label, single-center, randomized, comparative phase IV clinical trial. The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine manufactured by Sinovac (Beijing) Vaccine Technology Co., Ltd. with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine. 780 healthy infants of 6 months old as participants are randomly assigned into three experimental groups in the ratio 1:1:1. The group I receive EV71 Vaccine (first dose)\& recombinant hepatitis B vaccine on day 0 and EV71 vaccine (second dose)\& Group A meningococcal polysaccharide vaccine on day 30. The group II receive recombinant hepatitis B vaccine on day 0 and Group A meningococcal polysaccharide vaccine on day 30. The group III receive the first and second dose of EV71 Vaccine on day 0 and day 30 respectively.

Being tested
Concomitant administration of EV71 vaccine with EPI vaccines, Single injection of EPI vaccine, EV71 Vaccine only
Keywords
Inactivated Enterovirus Type 71 (EV71) Vaccine, Concomitant vaccination, 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.

  • Concomitant administration of EV71 vaccine with EPI vaccinesBiological

    1. The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.； the recombinant hepatitis B vaccine was manufactured by Shenzhen Kangtai Biological Products Co., Ltd; the Group A meningococcal polysaccharide vaccine was manufactured by Wuhan Institute of Biological Products Co., Ltd.
    2. The primary vaccination schedule of hepatitis B vaccine includes 3 doses with a schedule of 0,1,6 month, and subjects only receive 3rd vaccination in this study; the primary vaccination schedule of Group A meningococcal polysaccharide vaccine includes 2 doses with 3 months interval between doses, and subjects only receive 1st vaccination in this study

  • Single injection of EPI vaccineBiological

    1. The recombinant hepatitis B vaccine was manufactured by Shenzhen Kangtai Biological Products Co., Ltd; the Group A meningococcal polysaccharide vaccine was manufactured by Wuhan Institute of Biological Products Co., Ltd.
    2. The primary vaccination schedule of hepatitis B vaccine includes 3 doses with a schedule of 0,1,6 month, and subjects only receive 3rd vaccination in this study; the primary vaccination schedule of Group A meningococcal polysaccharide vaccine includes 2 doses with 3 months interval between doses, and subjects only receive 1st vaccination in this study

  • EV71 Vaccine onlyBiological

    The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.

Study groups in NCT03274102
Study groupRoleWhat they receive
Group I-EV71 vaccine and EPI vaccinesExperimentalConcomitant administration of EV71 vaccine with EPI vaccines: EV71 Vaccine (intramuscular injection,0.5ml,first dose)/recombinant hepatitis B vaccine（intramuscular injection,0.5ml）on day 0 and EV71 Vaccine (injection, 0.5ml,second dose)/ Group A meningococcal polysaccharide vaccine(subcutaneous injection, 150ug) on day 30.
Receives: Biological: Concomitant administration of EV71 vaccine with EPI vaccines
Group II-EPI vaccine onlyActive comparatorSingle injection of EPI vaccine: recombinant hepatitis B vaccine (intramuscular injection, 0.5ml) on day 0 and Group A meningococcal polysaccharide vaccine (subcutaneous injection,150ug) on day 30.
Receives: Biological: Single injection of EPI vaccine
Group III-EV71 vaccine onlyActive comparatorEV71 Vaccine only: the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 and day 30 respectively.
Receives: Biological: EV71 Vaccine only

What is being measured

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

  1. The seropositive rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody 1 month after 2 doses of vaccination

    Immunogenicity indicator

    Measured: 30 days after 2 doses of injection

Secondary outcomes (5)

  1. Incidence of solicited local or systemic adverse events within 7 days after each dose

    Safety indicator

    Measured: 7 days after each dose of injection

  2. Incidence of unsolicited local or systemic adverse events within 30 days after each dose

    Safety indicator

    Measured: 30 days after each dose of injection

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

    Safety indicator

    Measured: 60 days after the first dose injection

  4. The seroconversion rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody(SBA) 1 month after 2 doses of vaccination

    Immunogenicity indicator

    Measured: 30 days after 2 doses of injection

  5. EV71 neutralizing antibody GMT, anti-HBs GMC and SBA antibody GMT 1 month after 2 doses of vaccination

    Immunogenicity indicator

    Measured: 30 days after 2 doses of injection

Timeline

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

  1. First posted6 Sep 2017
  2. Study start22 Apr 2017
  3. Primary completion1 Nov 2017
  4. Study completion1 Nov 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
780 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03274102
Sponsor's protocol ID
PRO-EV71-4003
Status last verified
Dec 2018
First submitted
4 Sep 2017
Last updated
29 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Z, Liang Z, Zeng J, Zhang J, He P, Su J, Zeng Y, Fan R, Zhao D, Ma W, Zeng G, Zhang Q, Zheng H. Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial. J Infect Dis. 2019 Jul 2;220(3):392-399. doi: 10.1093/infdis/jiz129.

    PubMed 30891604

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Concomitant administration of EV71 vaccine with EPI vaccines, Single injection of EPI vaccine and EV71 Vaccine only 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 4 inclusion and 28 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 seropositive rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody 1 month after 2 doses of vaccination (time frame: 30 days after 2 doses of injection). 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 NCT03274102, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in