Enterovirus InfectionsPhase 4NCT04091880

Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine

A Phase 4 study testing EV71 vaccine and influenza vaccine, EV71 vaccine and influenza vaccine in people with Enterovirus Infections and Influenza, run by China National Biotec Group Company Limited 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

Subjects will be recruited and divided into 3 groups: 1. Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine; 2. Control Group A (378 subjects): EV71 vaccine only; 3. Read more about this study

Who is it for?: Ages 6 to 11 monthsHealthy volunteers can take part
Conditions the study is for: Enterovirus Infections, Influenza
What is being tested?: EV71 vaccine and influenza vaccine, EV71 vaccine and influenza vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,134 participants
Where: 1 siteChina
Study dates: 26 Sep 2019to 10 Aug 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 6 to 11 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

subjects aged from 6-11 months old at the date of recruitment;
with informed consent signed by parent(s) or guardians;
parent(s) or guardians are able to attend all planned clinical appointments and comply with all study instructions;
subjects not receive any vaccination within 14 days at the date of recruitment;
subjects have not been vaccinated with EV71 vaccine, seasonal flu vaccine;
subjects with no medical history of EV71 infection;
axillary temperature ≤37.0℃

Who cannot join

subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
allergic to any ingredient of vaccine or with allergy history to any vaccine;
subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
administration of immunoglobulins within 30 days prior to this study;
acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
have a clearly diagnosed history of thrombocytopenia or other coagulopathy,

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may cause contraindications for subcutaneous injection;
any serious chronic illness, acute infectious diseases, or respiratory diseases;
severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
any kind of infectious, purulent, or allergic skin diseases;
any other factor that makes the investigator determines the subject is unsuitable for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhejiang provincial center for disease control and prevention
Hangzhou, Zhejiang, 310051

Other trials in China

About this study

Official title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated

Subjects will be recruited and divided into 3 groups:

Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine;
Control Group A (378 subjects): EV71 vaccine only;
Control Group B (378 subjects): influenza vaccine only;

All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Read the detailed description

To further evaluate the feasibility of simultaneously administration of EV71 vaccine and flu vaccine, we design this clinical trial to test its immunogenicity and safety. 1134 subjects aged from 6 to 11 months old are divided into one experimental group and two control groups (control group A and B).

378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously. Blood samples are collected before the first vaccination, and one month following the second vaccination.

378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination.

378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination.

To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

Conditions: Enterovirus Infections, Influenza
Being tested: EV71 vaccine and influenza vaccine, EV71 vaccine, influenza vaccine
Keywords: EV71 vaccine, influenza vaccine, simultaneously administration
Medical subject headings: Enterovirus Infections, Influenza, Human

What participants receive

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

EV71 vaccine and influenza vaccineBiological
simultaneously administrated with EV71 vaccine and influenza vaccine
EV71 vaccineBiological
administrated with EV71 vaccine only
influenza vaccineBiological
administrated with influenza vaccine only

Study groups in NCT04091880
Study group	Role	What they receive
experimental group	Experimental	378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously. Receives: Biological: EV71 vaccine and influenza vaccine
control group A	Active comparator	378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart). Receives: Biological: EV71 vaccine
control group B	Active comparator	378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart). Receives: Biological: influenza vaccine

What is being measured

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

Seroconversion rate I
the rate of positive seroconversion against EV71
Measured: Baseline (before vaccination) and 1 month after the last dose
Seroconversion rate II
the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses
Measured: Baseline (before vaccination ) and 1 month after the last dose
Geometric mean titer (GMT) I
Measure neutralizing antibody titers against EV71
Measured: Baseline (before vaccination) and 1 month after the last dose
Geometric mean titer (GMT) II
Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses
Measured: Baseline (before vaccination) and 1 month after the last dose

Secondary outcomes (1)

adverse events following vaccination
analyse the numbers and rates of participants who experience adverse events following immunization
Measured: 6 months

Timeline

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

26 Sep 201910 Aug 2021

First posted17 Sep 2019
Study start26 Sep 2019
Primary completion6 Jan 2020
Study completion10 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Enterovirus InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04091880
Sponsor's protocol ID: EV71-Flu-Combine-01
Status last verified: Oct 2022
First submitted: 15 Sep 2019
Last updated: 12 Oct 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen Y, Xiao Y, Ye Y, Jiang F, He H, Luo L, Chen H, Shi L, Mu Q, Chen W, Guo X, Zhang M, Li J, Guan Q, Chen Z, Yang X. Immunogenicity and safety of an inactivated enterovirus 71 vaccine coadministered with trivalent split-virion inactivated influenza vaccine: A phase 4, multicenter, randomized, controlled trial in China. Front Immunol. 2022 Dec 8;13:1080408. doi: 10.3389/fimmu.2022.1080408. eCollection 2022.
PubMed 36569946

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated
ClinicalTrials.gov ID: NCT04091880
Acronym / sponsor ID: EV71-Flu-Combine-01
Conditions: Enterovirus Infections, Influenza
Keywords: EV71 vaccine, influenza vaccine, simultaneously administration
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,134 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Zhejiang Provincial Center for Disease Control and Prevention, Henan Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Wuhan Institute of Biological Products Co., Ltd, Changchun Institute of Biological Products Co., Ltd., Peking University, National Institutes for Food and Drug Control, China
Study start: 26 Sep 2019 (actual)
Primary completion: 6 Jan 2020 (actual)
Study completion: 10 Aug 2021 (actual)
First posted: 17 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Subjects will be recruited and divided into 3 groups:

Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine;
Control Group A (378 subjects): EV71 vaccine only;
Control Group B (378 subjects): influenza vaccine only;

All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
experimental group	Experimental	Biological: EV71 vaccine and influenza vaccine378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously.
control group A	Active comparator	Biological: EV71 vaccine378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart).
control group B	Active comparator	Biological: influenza vaccine378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart).

Who may qualify

Ages: 6 to 11 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

subjects aged from 6-11 months old at the date of recruitment;
with informed consent signed by parent(s) or guardians;
parent(s) or guardians are able to attend all planned clinical appointments and comply with all study instructions;
subjects not receive any vaccination within 14 days at the date of recruitment;
subjects have not been vaccinated with EV71 vaccine, seasonal flu vaccine;

Key exclusion criteria (11 listed)

subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
allergic to any ingredient of vaccine or with allergy history to any vaccine;
subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
administration of immunoglobulins within 30 days prior to this study;
acute febrile disease(temperature ≥ 37.0°C) or infectious disease;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EV71 vaccine and influenza vaccinesimultaneously administrated with EV71 vaccine and influenza vaccine	Biological	experimental group
EV71 vaccineadministrated with EV71 vaccine only	Biological	control group A
influenza vaccineadministrated with influenza vaccine only	Biological	control group B

Primary outcome

Seroconversion rate I
Time frame: Baseline (before vaccination) and 1 month after the last dose
the rate of positive seroconversion against EV71
Seroconversion rate II
Time frame: Baseline (before vaccination ) and 1 month after the last dose
the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses
Geometric mean titer (GMT) I
Time frame: Baseline (before vaccination) and 1 month after the last dose
Measure neutralizing antibody titers against EV71
Geometric mean titer (GMT) II
Time frame: Baseline (before vaccination) and 1 month after the last dose
Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses

1 secondary outcome

adverse events following vaccination
Time frame: 6 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Derived from this study: PubMed 36569946Chen Y, Xiao Y, Ye Y, Jiang F, He H, Luo L, Chen H, Shi L, Mu Q, Chen W, Guo X, Zhang M, Li J, Guan Q, Chen Z, Yang X. Immunogenicity and safety of an inactivated enterovirus 71 vaccine coadministered with trivalent split-virion inactivated influenza vaccine: A phase 4, multicenter, randomized, controlled trial in China. Front Immunol. 2022 Dec 8;13:1080408. doi: 10.3389/fimmu.2022.1080408. eCollection 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hanqing He principal investigator

Zhejiang Provincial Center for Disease Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 11 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 12 Oct 2022. 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?

Seroconversion rate I (time frame: Baseline (before vaccination) and 1 month after the last dose). The study lists 4 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 NCT04091880, 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 12 Oct 2022.