Hand, Foot and Mouth DiseaseNCT03281174
Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine
An observational study of Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd. 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
- Type of treatment
- Vaccines
- How many people
- 343 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2017to 21 May 2017
- 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 35 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The studied subjects are infants aged 6-35 months old infants when enrolled into the phase III clinical trial, and they are children aged 6-8 years old five years after the EV71 vaccine /placebo injection.
Who may be able to join
- In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with 435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).
- The subjects in Sheyang immunogenicity subgroup with the following conditions were included in this study:
- 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
- Received at least one injection of EV71 vaccine or the placebo in the phase III clinical trial
- Finished the blood sampling 64 months after the vaccination
Who cannot join
- Received extra EV71 vaccination after the phase III clinical trial
- Refused to join the study
Trial locations and contacts
1 site in 1 country.
China1 site
Sheyang Center for Disease Control and Prevention
Yancheng, Jiangsu, 210009
About this study
Official title: Phase IV, Open-labelled, Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine
The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.
Read the detailed description
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014.
On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- Inactivated Enterovirus Type 71 (EV71) Vaccine, 5-year Immune Persistence
- 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.
| Study group | Role | What they receive |
|---|---|---|
| EV71 vaccine group | The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial. | |
| Placebo group | The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seropositive rate of EV71 neutralizing antibody-1
Calculated based on the cutoff value of 1:8
Measured: 5 years (64 months)
Secondary outcomes (3)
The seropositive rate of EV71 neutralizing antibody-2
Calculated based on the cutoff value of 1:16
Measured: 5 years (64 months)
The seropositive rate of EV71 neutralizing antibody-3
Calculated based on the cutoff value of 1:32
Measured: 5 years (64 months)
The GMT of EV71 neutralizing antibody
The GMT of EV71 neutralizing antibody 64 months after the first dose injection
Measured: 5 years (64 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start20 May 2017
- Primary completion21 May 2017
- Study completion21 May 2017
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 Hand, Foot and Mouth DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuemei Hu, Principal investigator, Jiangsu Provicial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281174
- Sponsor's protocol ID
- PRO-EV71-4007
- Status last verified
- Sep 2017
- First submitted
- 8 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu Y, Zeng G, Chu K, Zhang J, Han W, Zhang Y, Li J, Zhu F. Five-year immunity persistence following immunization with inactivated enterovirus 71 type (EV71) vaccine in healthy children: A further observation. Hum Vaccin Immunother. 2018 Jun 3;14(6):1517-1523. doi: 10.1080/21645515.2018.1442997. Epub 2018 Apr 11.
PubMed 29482422
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Open-labelled, Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine
- ClinicalTrials.gov ID
- NCT03281174
- Acronym / sponsor ID
- PRO-EV71-4007
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- Inactivated Enterovirus Type 71 (EV71) Vaccine, 5-year Immune Persistence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2017 (actual)
- Primary completion
- 21 May 2017 (actual)
- Study completion
- 21 May 2017 (actual)
- First posted
- 13 Sep 2017 (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 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.
Detailed description
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014.
On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV71 vaccine group | – | –The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial. |
| Placebo group | – | –The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The studied subjects are infants aged 6-35 months old infants when enrolled into the phase III clinical trial, and they are children aged 6-8 years old five years after the EV71 vaccine /placebo injection.
Key inclusion criteria (5 listed)
- In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with 435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).
- The subjects in Sheyang immunogenicity subgroup with the following conditions were included in this study:
- 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
- Received at least one injection of EV71 vaccine or the placebo in the phase III clinical trial
- Finished the blood sampling 64 months after the vaccination
Key exclusion criteria (2 listed)
- Received extra EV71 vaccination after the phase III clinical trial
- Refused to join the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The seropositive rate of EV71 neutralizing antibody-1
Time frame: 5 years (64 months)
Calculated based on the cutoff value of 1:8
3 secondary outcomes
The seropositive rate of EV71 neutralizing antibody-2
Time frame: 5 years (64 months)
The seropositive rate of EV71 neutralizing antibody-3
Time frame: 5 years (64 months)
The GMT of EV71 neutralizing antibody
Time frame: 5 years (64 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 13 Sep 2017.
- Derived from this study: PubMed 29482422Hu Y, Zeng G, Chu K, Zhang J, Han W, Zhang Y, Li J, Zhu F. Five-year immunity persistence following immunization with inactivated enterovirus 71 type (EV71) vaccine in healthy children: A further observation. Hum Vaccin Immunother. 2018 Jun 3;14(6):1517-1523. doi: 10.1080/21645515.2018.1442997. Epub 2018 Apr 11.
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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.
Yuemei Hu principal investigator
Jiangsu Provicial 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?
An observational study of 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 5 inclusion and 2 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 Sep 2017. 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.
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-1 (time frame: 5 years (64 months)). 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 NCT03281174, 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 13 Sep 2017; AzTrials last refreshed its copy on 29 Oct 2026.