Enterovirus 71 VaccinePhase 4NCT02806531
Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old
A Phase 4 study testing two doses enterovirus 71 vaccine in people with Enterovirus 71 Vaccine, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
Trial summary
This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Enterovirus 71 Vaccine
- What is being tested?
- two doses enterovirus 71 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2018
- 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 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant and toddlers aged 6 and 35 months, meeting the criteria of receiving vaccine based on the judgement of caregivers at vaccination clinic. And The legal guardian are willing to vaccination at his own expense.
Who cannot join
- History of allergy to any vaccine ingredient or gentamycin;
- Fever, or acute disease, or acute stage of chronic disease;
- Having serious chronic diseases, or allergic constitution;
- Refusal of follow-up for safety concern.
About this study
This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.
- Conditions
- Enterovirus 71 Vaccine
- Being tested
- two doses enterovirus 71 vaccine
- Keywords
- vaccine, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two doses enterovirus 71 vaccineBiological
Two doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval.
| Study group | Role | What they receive |
|---|---|---|
| two doses enterovirus 71 vaccine | Experimental | Two doses of enterovirus 71 vaccine will be given in aged 6-35 months old, 28 days interval. Receives: Biological: two doses enterovirus 71 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of adverse reactions of enterovirus 71 Vaccine
Adverse reactions associated with vaccine will be observed in subjects after each vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterovirus 71 VaccineStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806531
- Sponsor's protocol ID
- cycdc2016-2
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old
- ClinicalTrials.gov ID
- NCT02806531
- Acronym / sponsor ID
- cycdc2016-2
- Conditions
- Enterovirus 71 Vaccine
- Keywords
- vaccine, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- First posted
- 20 Jun 2016 (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.
This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| two doses enterovirus 71 vaccine | Experimental | Biological: two doses enterovirus 71 vaccineTwo doses of enterovirus 71 vaccine will be given in aged 6-35 months old, 28 days interval. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infant and toddlers aged 6 and 35 months, meeting the criteria of receiving vaccine based on the judgement of caregivers at vaccination clinic. And The legal guardian are willing to vaccination at his own expense.
Key exclusion criteria (4 listed)
- History of allergy to any vaccine ingredient or gentamycin;
- Fever, or acute disease, or acute stage of chronic disease;
- Having serious chronic diseases, or allergic constitution;
- Refusal of follow-up for safety concern.
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 |
|---|---|---|
| two doses enterovirus 71 vaccineTwo doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval. | Biological | two doses enterovirus 71 vaccine |
Primary outcome
The rate of adverse reactions of enterovirus 71 Vaccine
Time frame: 28 days
Adverse reactions associated with vaccine will be observed in subjects after each vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
Related trials for Enterovirus 71 Vaccine
Active, not recruitingPhase 3
A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years
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Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
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Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
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Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
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RecruitingPhase 3
Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing two doses enterovirus 71 vaccine in people with Enterovirus 71 Vaccine, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
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 4 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 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 rate of adverse reactions of enterovirus 71 Vaccine (time frame: 28 days). 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 20 Jun 2016.