Seasonal InfluenzaPhase 4NCT04133584
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
A Phase 4 study testing EV71 +SIV, EV71 and SIV in people with Seasonal Influenza and Hand, Foot and Mouth Disease, run by Zhejiang Provincial Center for Disease Control and Prevention at 1 site in China.
Trial summary
The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) Read more about this study
- Who is it for?
- Ages 6 to 11 months
- Conditions the study is for
- Seasonal Influenza, Hand, Foot and Mouth Disease
- What is being tested?
- EV71 +SIV, EV71 and SIV
- 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
- 16 Sep 2019to 30 Nov 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
- No healthy volunteers
- Child
Who may be able to join
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- Participant is aged ≥ 6 month to <12 months.
- Participant without preventive inoculation of Enterovirus 71 Vaccine ,seasonal influenza vaccine vaccine and previous history of Enterovirus.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Body temperature ≤ 37.0#.
Who cannot join
- Known allergy to any constituent of the vaccine.
- Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
- Known bleeding disorder.
- Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
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- Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
- An acute illness with or without fever (temperature ≥ 38.0#) in the 3 days preceding enrollment in the trial.
- Participation in any other intervention clinical trial.
- 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
1 site in 1 country.
About this study
Official title: Multiple Centers, Randomized, and Control Trail on the Immunogenicity and Safety of the Simultaneously Vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and Seasonal Influenza Vaccine(SIV)
The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)
Read the detailed description
Main subjects:
The seroconversion rate for each antigen when EV71 is administrated with SIV
Secondary subjects:
The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV
- Conditions
- Seasonal Influenza, Hand, Foot and Mouth Disease
- Being tested
- EV71 +SIV, EV71, SIV
- Keywords
- Immunogenicity, Safety, Enterovirus 71 Vaccine, seasonal influenza vaccine
- 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 +SIVBiological
Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.
EV71Biological
Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last
SIVBiological
Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last
| Study group | Role | What they receive |
|---|---|---|
| Group 1 EV71 +SIV | Experimental | Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart Receives: Biological: EV71 +SIV |
| Group 2 EV71 | Active comparator | Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart Receives: Biological: EV71 |
| Group 3 SIV | Active comparator | Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart Receives: Biological: SIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity evaluation
The positive rate of antibody
Measured: change from baseline antibody concentration at 28 days after the last dose
Secondary outcomes (1)
safety evaluation: The occurrence of adverse events
The occurrence of adverse events
Measured: up to 30 days after every injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start16 Sep 2019
- Primary completion30 Jun 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal InfluenzaStudies 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
- None (open label)
- Enrolment
- 1,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- China National Biotec Group Company Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133584
- Sponsor's protocol ID
- ZJCDC20190918
- Status last verified
- Jul 2022
- First submitted
- 18 Sep 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Centers, Randomized, and Control Trail on the Immunogenicity and Safety of the Simultaneously Vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and Seasonal Influenza Vaccine(SIV)
- ClinicalTrials.gov ID
- NCT04133584
- Acronym / sponsor ID
- ZJCDC20190918
- Conditions
- Seasonal Influenza, Hand, Foot and Mouth Disease
- Keywords
- Immunogenicity, Safety, Enterovirus 71 Vaccine, seasonal influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,134 participants (actual)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Collaborators
- China National Biotec Group Company Limited
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 21 Oct 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.
The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)
Detailed description
Main subjects:
The seroconversion rate for each antigen when EV71 is administrated with SIV
Secondary subjects:
The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 EV71 +SIV | Experimental | Biological: EV71 +SIVGive 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart |
| Group 2 EV71 | Active comparator | Biological: EV71Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart |
| Group 3 SIV | Active comparator | Biological: SIVGive 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart |
Who may qualify
- Ages
- 6 to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- Participant is aged ≥ 6 month to <12 months.
- Participant without preventive inoculation of Enterovirus 71 Vaccine ,seasonal influenza vaccine vaccine and previous history of Enterovirus.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Body temperature ≤ 37.0#.
Key exclusion criteria (10 listed)
- Known allergy to any constituent of the vaccine.
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 +SIVGive 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose. | Biological | Group 1 EV71 +SIV |
| EV71Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last | Biological | Group 2 EV71 |
| SIVGive 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last | Biological | Group 3 SIV |
Primary outcome
immunogenicity evaluation
Time frame: change from baseline antibody concentration at 28 days after the last dose
The positive rate of antibody
1 secondary outcome
safety evaluation: The occurrence of adverse events
Time frame: up to 30 days after every injection
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 13 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EV71 +SIV, EV71 and SIV in people with Seasonal Influenza and Hand, Foot and Mouth Disease, run by Zhejiang Provincial Center for Disease Control and Prevention 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 5 inclusion and 10 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 13 Jul 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?
immunogenicity evaluation (time frame: change from baseline antibody concentration at 28 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2022.