Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
NCT ID: NCT03893747
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
3000 participants
INTERVENTIONAL
2019-04-01
2020-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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the first batch vaccine producted by 40 L reactor
500 subjects will be randomly received the first batch vaccine producted by 40 L reactor
The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
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 vaccine producted by 40 L reactor
500 subjects will be randomly received the second batch vaccine producted by 40 L reactor
The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
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 vaccine producted by 40 L reactor
500 subjects will be randomly received the third batch vaccine producted by 40 L reactor
The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
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 vaccine producted by 150 L reactor
500 subjects will be randomly received the first batch vaccine producted by 150 L reactor
The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
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 vaccine producted by 150 L reactor
500 subjects will be randomly received the second batch vaccine producted by 150 L reactor
The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
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 vaccine proudected by 150 L reactor
500 subjects will be randomly received the third batch vaccine producted by 150 L reactor
The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
Interventions
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The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
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 reactor
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 reactor
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 reactor
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 reactor
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 reactor
500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
* Acute infection or illness
* Other factors that are not suitable for clinical trials according to the judgment of researchers
6 Months
35 Months
ALL
Yes
Sponsors
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Wuhan Institute of Biological Products Co., Ltd
INDUSTRY
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Locations
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Fengcai Zhu
Nanjing, , China
Countries
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Other Identifiers
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JSVCT048-2
Identifier Type: -
Identifier Source: org_study_id
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