Hand, Foot and Mouth DiseaseNCT05166044
Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai
An observational study of Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 6 sites in China.
Trial summary
This study is an open clinical trial of the EV71 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co.,Ltd.The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), Inactivated co-administration with other vaccines Read more about this study
- Who is it for?
- Ages 6 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- EV71 Inactivated Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 12,500 participants
- Where
- 6 sitesChina
- Study dates
- 4 Jan 2022to 10 Aug 2022
- Phase
- Observational
- 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 71 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: In this study,only children aged 6-71 months old who were judged by vaccination doctors to be eligible for vaccination and voluntary and self-funded completion of EV71 vaccine combined immunization with one of the other type I or II vaccines were enrolled.
Who may be able to join
- 6 months ≤ Age of enrollment ≤71 months;
- Voluntary and self-funded completion of EV71 vaccine combined immunization with one of the other type I or II vaccines;
- The subject and/or guardian can understand and voluntarily sign the informed consent form;
- Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes).
Who cannot join
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 4 recruiting
- Recruiting
Baoshan District Center for Disease Control and Prevention
Baoshan, Shanghai Municipality, 201900
Xiaojun Li, 13641812162
- Recruiting
Jing'an District Center for Disease Control and Prevention
Jing’an, Shanghai Municipality, 200040
Ping Yu, 13761361802
- Recruiting
Minhang District Center for Disease Control and Prevention
Minhang, Shanghai Municipality, 201100
Liping Zhang, 18019709387
- Completed
Putuo District Center for Disease Control and Prevention
Putuo, Shanghai Municipality, 200333
- Completed
Qingpu District Center for Disease Control and Prevention
Qingpu, Shanghai Municipality, 201799
- Recruiting
Xuhui District Center for Disease Control and Prevention
Xuhui, Shanghai Municipality, 200030
Jingyi liu, 13585770812
About this study
Official title: Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization With Other Vaccines in Shanghai
This study is an open clinical trial of the EV71 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co.,Ltd.The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), Inactivated co-administration with other vaccines
Read the detailed description
This study is an open clinical trial in children aged 6-71 months old. The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), inactivated co-administration with other vaccines.The EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 12500 subjects aged 6-71 months old were enrolled.All subjects received one dose of EV71 vaccine and one of other vaccines(such as MMR vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- EV71 Inactivated 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 Inactivated VaccineBiological
The EV71 vaccine was manufactured by Sinovac Biotech Co,And inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
| Study group | Role | What they receive |
|---|---|---|
| Safety group | All of the participants(N=12500) received one dose of EV71 vaccine and one of other vaccines(such as MMR vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time. Receives: Biological: EV71 Inactivated Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety index-incidence of local and systemic adverse reactions
Incidence of local and systemic adverse reactions 0 to 3 days after each dose of EV71 vaccine combined immunization with other vaccines (except live attenuated vaccines)
Measured: From 0 to 3 days after vaccination
Safety index-the incidence of local and systemic adverse reactions
The incidence of local and systemic adverse reactions 0 to 14 days after each dose of EV71 vaccine combined with live attenuated vaccine
Measured: From 0 to 14 days after vaccination
Safety index-The incidence of adverse reactions
The incidence of adverse reactions 0-30 days after vaccination of EV71 vaccine combined immunization with other vaccines.
Measured: From 0 to 30 days after vaccination
Safety index-Incidence of serious adverse reactions
Incidence of serious adverse reactions 0 to 30 days after vaccination of EV71 vaccine combined immunization with other vaccines.
Measured: From 0 to 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start4 Jan 2022
- Primary completion4 Jun 2022
- Study completion10 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linlin Wu, Master, Principal investigator, Shanghai Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166044
- Sponsor's protocol ID
- EV71-SH-2020-01
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization With Other Vaccines in Shanghai
- ClinicalTrials.gov ID
- NCT05166044
- Acronym / sponsor ID
- EV71-SH-2020-01
- Conditions
- Hand, Foot and Mouth Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,500 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 10 Aug 2022 (estimated)
- First posted
- 21 Dec 2021 (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.
This study is an open clinical trial of the EV71 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co.,Ltd.The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), Inactivated co-administration with other vaccines
Detailed description
This study is an open clinical trial in children aged 6-71 months old. The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), inactivated co-administration with other vaccines.The EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 12500 subjects aged 6-71 months old were enrolled.All subjects received one dose of EV71 vaccine and one of other vaccines(such as MMR vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety group | – | Biological: EV71 Inactivated VaccineAll of the participants(N=12500) received one dose of EV71 vaccine and one of other vaccines(such as MMR vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time. |
Who may qualify
- Ages
- 6 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- In this study,only children aged 6-71 months old who were judged by vaccination doctors to be eligible for vaccination and voluntary and self-funded completion of EV71 vaccine combined immunization with one of the other type I or II vaccines were enrolled.
Key inclusion criteria (4 listed)
- 6 months ≤ Age of enrollment ≤71 months;
- Voluntary and self-funded completion of EV71 vaccine combined immunization with one of the other type I or II vaccines;
- The subject and/or guardian can understand and voluntarily sign the informed consent form;
- Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes).
Key exclusion criteria (1 listed)
- -
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 Inactivated VaccineThe EV71 vaccine was manufactured by Sinovac Biotech Co,And inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection. | Biological | Safety group |
Primary outcome
Safety index-incidence of local and systemic adverse reactions
Time frame: From 0 to 3 days after vaccination
Incidence of local and systemic adverse reactions 0 to 3 days after each dose of EV71 vaccine combined immunization with other vaccines (except live attenuated vaccines)
Safety index-the incidence of local and systemic adverse reactions
Time frame: From 0 to 14 days after vaccination
The incidence of local and systemic adverse reactions 0 to 14 days after each dose of EV71 vaccine combined with live attenuated vaccine
Safety index-The incidence of adverse reactions
Time frame: From 0 to 30 days after vaccination
The incidence of adverse reactions 0-30 days after vaccination of EV71 vaccine combined immunization with other vaccines.
Safety index-Incidence of serious adverse reactions
Time frame: From 0 to 30 days after vaccination
Incidence of serious adverse reactions 0 to 30 days after vaccination of EV71 vaccine combined immunization with other vaccines.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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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.
Linlin Wu, Master principal investigator
Shanghai Center for Disease Control and Prevention
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 6 sites 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 1 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: status not confirmed, as of the sponsor's last update on 11 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 6 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linlin Wu, Master (13651849237, wulinlin@scdc.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety index-incidence of local and systemic adverse reactions (time frame: From 0 to 3 days after vaccination). 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?
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 11 Jul 2022.