Hand, Foot and Mouth Disease (HFMD)Phase 4NCT03240744
The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)
A Phase 4 study testing Inactivated EV71 vaccine (human diploid cell, KMB-17) in people with Hand, Foot and Mouth Disease (HFMD), run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage. 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 (HFMD)
- What is being tested?
- Inactivated EV71 vaccine (human diploid cell, KMB-17)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2017to Oct 2020
- 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
- Healthy subjects (6-71 months old children) as established by medical history and clinical examination
- The subjects' legal guardian must be aware of this vaccines
- The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
- Subjects with temperature ≤ 37.0 ℃
- The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
- Persist for a 14-month visit (and receive blood, stool (or specimens by means of a swab) tests according to program requirements in immunogenicity observation group)
Who cannot join
- Allergy or serious side-effects to a vaccine or any ingredient of vaccine
- Epilepsy, seizures, convulsions, neurological illness
- Congenital or hereditary immunodeficiency
- Autoimmune disease
- Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
- Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
Show all 17Show fewer
- Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
- Acute illness or acute exacerbation of chronic disease in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of live-attenuated vaccine in last 15 days
- Any prior administration of subunit or inactivated vaccines in last 7 days
- Fever before vaccination, axillary temperature ﹥37.0 ℃
- The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
- Hypertension or hypotension. Systolic blood pressure ﹥140 mmHg and/ or diastolic blood pressure ﹥90 mmHg; systolic blood pressure ﹤90 mmHg and/or diastolic blood pressure ﹤60 mmHg
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- take part into other vaccine or drug clinical trials in last half year
Trial locations and contacts
1 site in 1 country.
China1 site
Hubei Province Center for Diseases Control and Prevention
Wuhan, Hubei
About this study
Official title: Study on Immunogenicity of Inactivated Enterovirus 71 (EV71) Vaccine (Human Diploid Cell, KMB-17) in Large-scale Healthy Children in China
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.
Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVc is to evaluated the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.
Read the detailed description
There are two parts of phase IVc clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old), within 56-day-post-immunized.
Second, to long-term immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).
- Conditions
- Hand, Foot and Mouth Disease (HFMD)
- Being tested
- Inactivated EV71 vaccine (human diploid cell, KMB-17)
- Keywords
- immunogenicity, safety, Hand, Foot and Mouth Disease (HFMD)
- 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.
Inactivated EV71 vaccine (human diploid cell, KMB-17)Biological
3.0 EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.
| Study group | Role | What they receive |
|---|---|---|
| vaccine (3.0EU) | Experimental | healthy children (6-71 months old) have been injected by inactivated EV71 vaccine (KMB-17) of 3.0 EU (neutralization antibodies titer unit; 100 U in phase III clinical trials, or 320 EU (Elisa assay unit) in phase I and II clinical trials) Receives: Biological: Inactivated EV71 vaccine (human diploid cell, KMB-17) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children
Bloods were obtained at 0 and 56 days after first vaccination. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.
Measured: at 28 days after finishing 2 doses immunization
Evaluate the antibody titers of anti-EV71 antibodies in serum of children
Bloods were obtained at 0 and 56 days after first vaccination. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.
Measured: at 28 days after finishing 2 doses immunization
Secondary outcomes (2)
Evaluate long-term of the seroconversion rate of anti-EV71 antibodies in serum of children
Bloods were obtained at 0, 28 and 56 days after first vaccination, and 180, 360 and 720 days after 2 doses immunization. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.
Measured: Up to 3 years after finishing 2 doses immunization
Evaluate long-term of the antibody titers of anti-EV71 antibodies in serum of children
Bloods were obtained at 0, 28 and 56 days after first vaccination, and 180, 360 and 720 days after 2 doses immunization. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.
Measured: Up to 3 years after finishing 2 doses immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start22 Jun 2017
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (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 Disease (HFMD)Studies 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
- Model description
- Inactivated EV71 vaccine (KMB-17 cells)
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Qihan Li, Chinese Academy of Medical Sciences
- Investigators
- Xuhua Guan, M.S., Principal investigator, Hubei Province Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240744
- Sponsor's protocol ID
- 2017-003-02
- Status last verified
- Apr 2017
- First submitted
- 22 Jun 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Immunogenicity of Inactivated Enterovirus 71 (EV71) Vaccine (Human Diploid Cell, KMB-17) in Large-scale Healthy Children in China
- ClinicalTrials.gov ID
- NCT03240744
- Acronym / sponsor ID
- 2017-003-02
- Conditions
- Hand, Foot and Mouth Disease (HFMD)
- Keywords
- immunogenicity, safety, Hand, Foot and Mouth Disease (HFMD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 7 Aug 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.
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.
Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVc is to evaluated the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.
Detailed description
There are two parts of phase IVc clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old), within 56-day-post-immunized.
Second, to long-term immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Inactivated EV71 vaccine (KMB-17 cells)
| Arm | Type | Receives |
|---|---|---|
| vaccine (3.0EU) | Experimental | Biological: Inactivated EV71 vaccine (human diploid cell, KMB-17)healthy children (6-71 months old) have been injected by inactivated EV71 vaccine (KMB-17) of 3.0 EU (neutralization antibodies titer unit; 100 U in phase III clinical trials, or 320 EU (Elisa assay unit) in phase I and II clinical trials) |
Who may qualify
- Ages
- 6 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy subjects (6-71 months old children) as established by medical history and clinical examination
- The subjects' legal guardian must be aware of this vaccines
- The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
- Subjects with temperature ≤ 37.0 ℃
- The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
Key exclusion criteria (17 listed)
- Allergy or serious side-effects to a vaccine or any ingredient of vaccine
- Epilepsy, seizures, convulsions, neurological illness
- Congenital or hereditary immunodeficiency
- Autoimmune disease
- Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
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 |
|---|---|---|
| Inactivated EV71 vaccine (human diploid cell, KMB-17)3.0 EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28. | Biological | vaccine (3.0EU) |
Primary outcome
Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children
Time frame: at 28 days after finishing 2 doses immunization
Bloods were obtained at 0 and 56 days after first vaccination. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.
Evaluate the antibody titers of anti-EV71 antibodies in serum of children
Time frame: at 28 days after finishing 2 doses immunization
Bloods were obtained at 0 and 56 days after first vaccination. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.
2 secondary outcomes
Evaluate long-term of the seroconversion rate of anti-EV71 antibodies in serum of children
Time frame: Up to 3 years after finishing 2 doses immunization
Evaluate long-term of the antibody titers of anti-EV71 antibodies in serum of children
Time frame: Up to 3 years after finishing 2 doses immunization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
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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.
Xuhua Guan, M.S. principal investigator
Hubei Province Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inactivated EV71 vaccine (human diploid cell, KMB-17) in people with Hand, Foot and Mouth Disease (HFMD), run by Chinese Academy of Medical Sciences 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 6 inclusion and 17 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 6 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.
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 seroconversion rate of anti-EV71 antibodies in serum of children (time frame: at 28 days after finishing 2 doses immunization). 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 6 Sep 2017.