Hand, Foot and Mouth DiseaseNCT02001233
A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
An observational study of Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 3 sites in China.
Trial summary
The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old. 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
- What is being tested?
- EV71 vaccine
- Type of treatment
- Vaccines
- How many people
- 10,077 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2013to Oct 2014
- 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: Healthy Chinese infants aged 6 to 35 months old
Who may be able to join
- All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.
Who cannot join
- subjects who refuse to continue in the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Ganyu
Lianyungang, Jiangsu, 222100
Taixing
Taizhou, Jiangsu, 225400
Sheyang
Yancheng, Jiangsu, 224300
About this study
Official title: An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine
The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.
Read the detailed description
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.
This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- EV71 vaccine
- Keywords
- EV71 vaccine, EV71-associated HFMD, efficacy, safety, 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.
EV71 vaccineBiological
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
| Study group | Role | What they receive |
|---|---|---|
| EV71 Vaccine | Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28 Receives: Biological: EV71 vaccine | |
| Placebo | placebo in 5000 infants aged 6-35 months old on day0,28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Measured: Within the second year after the second vaccination
Secondary outcomes (2)
The GMT of anti-EV71 antibodies in serum two years after second vaccination
to evaluate the immune persistence of anti-EV71 antibodies in serum
Measured: 26 months after second vaccination
Frequency of serious adverse events (SAEs) with the second year after the second vaccination
Frequency of serious adverse events in healthy infants during the oney-year follow-up period
Measured: within the second year after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionOct 2014
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 10,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng-Cai Zhu, BS, Principal investigator, Jiangsu Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001233
- Sponsor's protocol ID
- PRO-EV71-3003-0
- Status last verified
- May 2015
- First submitted
- 27 Nov 2013
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine
- ClinicalTrials.gov ID
- NCT02001233
- Acronym / sponsor ID
- PRO-EV71-3003-0
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- EV71 vaccine, EV71-associated HFMD, efficacy, safety, immune persistence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,077 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- 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 follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.
Detailed description
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.
This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV71 Vaccine | – | Biological: EV71 vaccineInactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28 |
| Placebo | – | –placebo in 5000 infants aged 6-35 months old on day0,28 |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy Chinese infants aged 6 to 35 months old
Key inclusion criteria (1 listed)
- All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.
Key exclusion criteria (1 listed)
- subjects who refuse to continue in 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EV71 vaccineinactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval | Biological | EV71 Vaccine |
Primary outcome
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
Time frame: Within the second year after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
2 secondary outcomes
The GMT of anti-EV71 antibodies in serum two years after second vaccination
Time frame: 26 months after second vaccination
Frequency of serious adverse events (SAEs) with the second year after the second vaccination
Time frame: within the second year after the second vaccination
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 26 May 2022.
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Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
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.
Feng-Cai Zhu, BS principal investigator
Jiangsu Center for Diseases Control and Prevention
3 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 3 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 1 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: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination (time frame: Within the second year after the second vaccination). 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 26 May 2022.