Hand, Foot and Mouth DiseasePhase 4NCT03893747
Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
A Phase 4 study testing The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor, The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor and The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor in people with Hand, Foot and Mouth Disease, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one… 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?
- The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor, The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor and The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 1 May 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 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 6-35 months
- Subjects who have been clinically judged to be healthy by the researcher after being asked about the medical history and related physical examination
- The subjects' guardians agree the requirements of the protocol and the relevant follow up visits
- The subjects' guardians agree and sign the informed consent
- Subjects who have no relocation or long-term travel plan within one year and are able to comply with the requirements of the clinical trial protocol.
Who cannot join
- Subject who has a medical history of HFMD caused by EV71 or has been vaccinated with EV71 vaccine
- Subject that has a history of allergies to vaccines or vaccine ingredients, and has serious side effects on vaccines, such as allergies, urticaria, dyspnea, vascular neuroedema or abdominal pain
- Subject who has congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Subject who has a history of epilepsy, convulsion or convulsion, or a family history of mental illness
- Subject who has autoimmune disease or immune deficiency, or whose parents and siblings have autoimmune disease or immune deficiency
- Subject who has a history of asthma, vascular and neuroedema, diabetes or malignant tumor
Show all 23Show fewer
- Subject who has a thyroid resection history, or received treatment due to thyroid disease in the past 12 months
- Subject who has an abnormal coagulation function (such as coagulation factor deficiency, coagulant disease, platelet abnormality) or obvious bruising or clotting disorder which was diagnosed by doctors.
- Asplenia, functional asplenia, or splenectomy due to any circumstances
- Acute onset of various acute or chronic diseases in the last 7 days
- Immunosuppressant therapy, antiallergic therapy, cytotoxicity therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-dermatitis) in the past 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of other research medicines or vaccines in last 1 month
- Any prior administration of attenuated live vaccine in last 15 days
- Any prior administration of subunit or inactivated vaccines in last 7 days
- Under the anti-TB prevention or therapy
- Underarm temperature > 37.0 ℃ for fever before vaccination
- Other factors that are not suitable for clinical trials according to the judgment of researchers
- Have severe allergic reaction after first dose
- Have severe adverse reactions related to first dose
- Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
- Acute infection or illness
- Other factors that are not suitable for clinical trials according to the judgment of researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor, The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor, The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor, The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor, The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
- 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 of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactorBiological
500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactorBiological
500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactorBiological
500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactorBiological
500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactorBiological
500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactorBiological
500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
| Study group | Role | What they receive |
|---|---|---|
| the first batch vaccine producted by 40 L reactor | Experimental | 500 subjects will be randomly received the first batch vaccine producted by 40 L reactor Receives: Biological: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor |
| the second batch vaccine producted by 40 L reactor | Experimental | 500 subjects will be randomly received the second batch vaccine producted by 40 L reactor Receives: Biological: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor |
| the third batch vaccine producted by 40 L reactor | Experimental | 500 subjects will be randomly received the third batch vaccine producted by 40 L reactor Receives: Biological: The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor |
| the first batch vaccine producted by 150 L reactor | Experimental | 500 subjects will be randomly received the first batch vaccine producted by 150 L reactor Receives: Biological: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor |
| the second batch vaccine producted by 150 L reactor | Experimental | 500 subjects will be randomly received the second batch vaccine producted by 150 L reactor Receives: Biological: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor |
| the third batch vaccine proudected by 150 L reactor | Experimental | 500 subjects will be randomly received the third batch vaccine producted by 150 L reactor Receives: Biological: The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of different batches for geometric mean titre(GMT) after vaccination
Consistency of different batches for GMT of EV-A71 neutralizing antibody on 56 day after vaccination
Measured: 56 days after vaccination
Incidence and severity of adverse reactions/adverse events after each dose
Incidence and severity of adverse reactions/adverse events within 1 month after each dose
Measured: 1 month after each dose
Secondary outcomes (7)
Incidence of sever adverse events after vaccination
Incidence of sever adverse events within 13 months after vaccination
Measured: 13 months after vaccination
GMTof EV-A71 neutralizing antibody on day 56 after vaccination
GMTof EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Measured: 56 days after vaccination
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Measured: 56 days after vaccination
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Measured: 56 days after vaccination
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Measured: 56 days after vaccination
GMTof EV-A71 neutralizing antibody on month 13 after vaccination
GMTof EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
Measured: 13 months after vaccination
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
Measured: 13 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Apr 2019
- Primary completion1 May 2020
- Study completion1 May 2020
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Wuhan Institute of Biological Products Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893747
- Sponsor's protocol ID
- JSVCT048-2
- Status last verified
- May 2021
- First submitted
- 26 Mar 2019
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
- ClinicalTrials.gov ID
- NCT03893747
- Acronym / sponsor ID
- JSVCT048-2
- Conditions
- Hand, Foot and Mouth Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Wuhan Institute of Biological Products Co., Ltd
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 28 Mar 2019 (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.
This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| the first batch vaccine producted by 40 L reactor | Experimental | Biological: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor500 subjects will be randomly received the first batch vaccine producted by 40 L reactor |
| the second batch vaccine producted by 40 L reactor | Experimental | Biological: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor500 subjects will be randomly received the second batch vaccine producted by 40 L reactor |
| the third batch vaccine producted by 40 L reactor | Experimental | Biological: The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor500 subjects will be randomly received the third batch vaccine producted by 40 L reactor |
| the first batch vaccine producted by 150 L reactor | Experimental | Biological: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor500 subjects will be randomly received the first batch vaccine producted by 150 L reactor |
| the second batch vaccine producted by 150 L reactor | Experimental | Biological: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor500 subjects will be randomly received the second batch vaccine producted by 150 L reactor |
| the third batch vaccine proudected by 150 L reactor | Experimental | Biological: The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor500 subjects will be randomly received the third batch vaccine producted by 150 L reactor |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 6-35 months
- Subjects who have been clinically judged to be healthy by the researcher after being asked about the medical history and related physical examination
- The subjects' guardians agree the requirements of the protocol and the relevant follow up visits
- The subjects' guardians agree and sign the informed consent
- Subjects who have no relocation or long-term travel plan within one year and are able to comply with the requirements of the clinical trial protocol.
Key exclusion criteria (23 listed)
- Subject who has a medical history of HFMD caused by EV71 or has been vaccinated with EV71 vaccine
- Subject that has a history of allergies to vaccines or vaccine ingredients, and has serious side effects on vaccines, such as allergies, urticaria, dyspnea, vascular neuroedema or abdominal pain
- Subject who has congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Subject who has a history of epilepsy, convulsion or convulsion, or a family history of mental illness
- Subject who has autoimmune disease or immune deficiency, or whose parents and siblings have autoimmune disease or immune deficiency
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 of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor | Biological | the first batch vaccine producted by 40 L reactor |
| The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor | Biological | the second batch vaccine producted by 40 L reactor |
| The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor | Biological | the third batch vaccine producted by 40 L reactor |
| The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor | Biological | the first batch vaccine producted by 150 L reactor |
| The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor | Biological | the second batch vaccine producted by 150 L reactor |
| The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor | Biological | the third batch vaccine proudected by 150 L reactor |
Primary outcome
Consistency of different batches for geometric mean titre(GMT) after vaccination
Time frame: 56 days after vaccination
Consistency of different batches for GMT of EV-A71 neutralizing antibody on 56 day after vaccination
Incidence and severity of adverse reactions/adverse events after each dose
Time frame: 1 month after each dose
Incidence and severity of adverse reactions/adverse events within 1 month after each dose
7 secondary outcomes
Incidence of sever adverse events after vaccination
Time frame: 13 months after vaccination
GMTof EV-A71 neutralizing antibody on day 56 after vaccination
Time frame: 56 days after vaccination
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination
Time frame: 56 days after vaccination
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination
Time frame: 56 days after vaccination
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination
Time frame: 56 days after vaccination
GMTof EV-A71 neutralizing antibody on month 13 after vaccination
Time frame: 13 months after vaccination
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination
Time frame: 13 months after 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 24 May 2021.
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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.
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 The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor, The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor and The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor in people with Hand, Foot and Mouth Disease, run by Jiangsu Province Centers for Disease Control and Prevention 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 23 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 24 May 2021. 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?
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?
Consistency of different batches for geometric mean titre(GMT) after vaccination (time frame: 56 days after vaccination). 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 24 May 2021.