Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Study Details
Study Description
Brief 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 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: the first batch vaccine producted by 40 L reactor 500 subjects will be randomly received the first batch vaccine producted by 40 L reactor |
Biological: 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
|
Experimental: the second batch vaccine producted by 40 L reactor 500 subjects will be randomly received the second batch vaccine producted by 40 L reactor |
Biological: 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
|
Experimental: the third batch vaccine producted by 40 L reactor 500 subjects will be randomly received the third batch vaccine producted by 40 L reactor |
Biological: 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
|
Experimental: the first batch vaccine producted by 150 L reactor 500 subjects will be randomly received the first batch vaccine producted by 150 L reactor |
Biological: 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
|
Experimental: the second batch vaccine producted by 150 L reactor 500 subjects will be randomly received the second batch vaccine producted by 150 L reactor |
Biological: 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
|
Experimental: the third batch vaccine proudected by 150 L reactor 500 subjects will be randomly received the third batch vaccine producted by 150 L reactor |
Biological: 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
|
Outcome Measures
Primary Outcome Measures
- Consistency of different batches for geometric mean titre(GMT) after vaccination [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 [1 month after each dose]
Incidence and severity of adverse reactions/adverse events within 1 month after each dose
Secondary Outcome Measures
- Incidence of sever adverse events after vaccination [13 months after vaccination]
Incidence of sever adverse events within 13 months after vaccination
- GMTof EV-A71 neutralizing antibody on day 56 after vaccination [56 days after vaccination]
GMTof EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
- Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination [56 days after vaccination]
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
- Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination [56 days after vaccination]
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
- Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination [56 days after vaccination]
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
- GMTof EV-A71 neutralizing antibody on month 13 after vaccination [13 months after vaccination]
GMTof EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
- Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination [13 months after vaccination]
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy children aged 6-35 months
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Subjects who have been clinically judged to be healthy by the researcher after being asked about the medical history and related physical examination
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The subjects' guardians agree the requirements of the protocol and the relevant follow up visits
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The subjects' guardians agree and sign the informed consent
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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:
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Subject who has a medical history of HFMD caused by EV71 or has been vaccinated with EV71 vaccine
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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
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Subject who has congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
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Subject who has a history of epilepsy, convulsion or convulsion, or a family history of mental illness
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Subject who has autoimmune disease or immune deficiency, or whose parents and siblings have autoimmune disease or immune deficiency
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Subject who has a history of asthma, vascular and neuroedema, diabetes or malignant tumor
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Subject who has a thyroid resection history, or received treatment due to thyroid disease in the past 12 months
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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.
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Asplenia, functional asplenia, or splenectomy due to any circumstances
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Acute onset of various acute or chronic diseases in the last 7 days
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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
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Any prior administration of blood products in last 3 months
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Any prior administration of other research medicines or vaccines in last 1 month
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Any prior administration of attenuated live vaccine in last 15 days
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Any prior administration of subunit or inactivated vaccines in last 7 days
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Under the anti-TB prevention or therapy
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Underarm temperature > 37.0 ℃ for fever before vaccination
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Other factors that are not suitable for clinical trials according to the judgment of researchers
Exclusion Criteria for the second dose:
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Have severe allergic reaction after first dose
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Have severe adverse reactions related to first dose
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Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
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Acute infection or illness
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Other factors that are not suitable for clinical trials according to the judgment of researchers
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fengcai Zhu | Nanjing | China |
Sponsors and Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
- Wuhan Institute of Biological Products Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JSVCT048-2