Hand Foot and Mouth DiseasePhase 4NCT02889497
Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months
A Phase 4 study testing the first batch vaccine, the second batch vaccine and the third batch vaccine in people with Hand Foot and Mouth Disease, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
Trial summary
This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be… 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?
- the first batch vaccine, the second batch vaccine and the third batch vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,900 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2019
- 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 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8 Months to 71 Months (Healthy Children or Infants)；
- Providing the subjects' legal identity certificate (birth certificate , residence booklet or ID card) and vaccination certificate, legal guardians can provide legal identity proof (resident booklet or ID card) so that the doctor can determine the subject identity to complete recruitment program；
- The subjects' guardians are able to understand and sign the informed consent voluntary. Guardians have the ability to use the thermometer ,dividing ruler and can fill out the Diary card ,follow-up card according to requirements；
- Persist for a 24 months visit.If doubtful HFMD case happen，the subject's guardian should send the subject to the medical institutions at above the county level and report this case to the investigator.The subjects who participate immunogenicity observation group can receive sample collection including blood，throat swab or anal awab according to program requirements.
Who cannot join
- Subject with clinical diagnosis or suspect HFMD（Especially the history of herpangina）；
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine；
- History of seizures,convulsions or twitching ;Family history of progressive neurological disease；
- Autoimmune disease or immunologic deficiency.Any prior administration of immunodepressant in last 6month；
- History of asthma，thyroid ablation，angioneurotic edema, diabetes mellitus or malignant tumour；
- Alienia，functional asplenia，or any condition that cause asplenia or splenectomy；
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- Diagnosed coagulation abnormalities (such as clotting factor deficiency, coagulation disorders, platelet disorder) or significant bruising or blood clotting disorder；
- Any acute disease or chronic disease attack in last 7 days；
- Any prior administration of blood products in last 3 month；
- Any prior administration of attenuated live vaccine in last 15 days , subunit or inactivated vaccines in last 7 days；
- Fever before vaccination, axillary temperature ﹥37.0℃；
- Attend Other vaccine or drug clinical trials concurrent in 6 months；
- Any condition that in the opinion of the investigator。
- Any exclusion criteria for the first dose happens after been enrolled；
- Newly HFMD diagnosed patients after been enrolled；
- Any condition that in the opinion of the investigator or ethics committee think should be eliminated.
About this study
This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.
- Conditions
- Hand Foot and Mouth Disease
- Being tested
- the first batch vaccine, the second batch vaccine, the third batch vaccine
- Keywords
- vaccine, safety, immunogenicity
- 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.
the first batch vaccineBiological
the second batch vaccineBiological
the third batch vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| 300 subjects receive the first batch vaccine | Experimental | 300 subjects will be randomly received the first batch vaccine Receives: Biological: the first batch vaccine |
| 300 subjects receive the second batch vaccine | Experimental | 300 subjects will be randomly received the second batch vaccine Receives: Biological: the second batch vaccine |
| 300 subjects receive the third batch vaccine | Experimental | 300 subjects will be randomly received the third batch vaccine Receives: Biological: the third batch vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months.
Adverse reactions associated with vaccine will be observed in Children Aged 6-71 Months after 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: 24 months
Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination.
The seroconversion rate of EV71 antibodies will be evaluated in serum at days 0 and 56.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20,900 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
- NCT02889497
- Sponsor's protocol ID
- cycdc2016-6
- Status last verified
- Aug 2016
- First submitted
- 31 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months
- ClinicalTrials.gov ID
- NCT02889497
- Acronym / sponsor ID
- cycdc2016-6
- Conditions
- Hand Foot and Mouth Disease
- Keywords
- vaccine, safety, immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20,900 participants (estimated)
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 5 Sep 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 study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 300 subjects receive the first batch vaccine | Experimental | Biological: the first batch vaccine300 subjects will be randomly received the first batch vaccine |
| 300 subjects receive the second batch vaccine | Experimental | Biological: the second batch vaccine300 subjects will be randomly received the second batch vaccine |
| 300 subjects receive the third batch vaccine | Experimental | Biological: the third batch vaccine300 subjects will be randomly received the third batch vaccine |
Who may qualify
- Ages
- 6 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 8 Months to 71 Months (Healthy Children or Infants)；
- Providing the subjects' legal identity certificate (birth certificate , residence booklet or ID card) and vaccination certificate, legal guardians can provide legal identity proof (resident booklet or ID card) so that the doctor can determine the subject identity to complete recruitment program；
- The subjects' guardians are able to understand and sign the informed consent voluntary. Guardians have the ability to use the thermometer ,dividing ruler and can fill out the Diary card ,follow-up card according to requirements；
- Persist for a 24 months visit.If doubtful HFMD case happen，the subject's guardian should send the subject to the medical institutions at above the county level and report this case to the investigator.The subjects who participate immunogenicity observation group can receive sample collection including blood，throat swab or anal awab according to program requirements.
Key exclusion criteria (16 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 |
|---|---|---|
| the first batch vaccine | Biological | 300 subjects receive the first batch vaccine |
| the second batch vaccine | Biological | 300 subjects receive the second batch vaccine |
| the third batch vaccine | Biological | 300 subjects receive the third batch vaccine |
Primary outcome
Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months.
Time frame: 24 months
Adverse reactions associated with vaccine will be observed in Children Aged 6-71 Months after 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.
Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination.
Time frame: 56 days
The seroconversion rate of EV71 antibodies will be evaluated in serum at days 0 and 56.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing the first batch vaccine, the second batch vaccine and the third batch vaccine in people with Hand Foot and Mouth Disease, 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 4 inclusion and 16 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 7 Sep 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?
Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months. (time frame: 24 months). The study lists 2 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 7 Sep 2016.