Clinical trial NCT03893747: Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Official title: Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand, Foot and Mouth Disease
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Wuhan Institute of Biological Products Co., Ltd
First posted: 2019-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Exclusion Criteria for the second dose:

* 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

Primary outcomes:
measure: Consistency of different batches for geometric mean titre(GMT) after vaccination
timeFrame: 56 days after vaccination
measure: Incidence and severity of adverse reactions/adverse events after each dose
timeFrame: 1 month after each dose
Secondary outcomes:
measure: Incidence of sever adverse events after vaccination
timeFrame: 13 months after vaccination
measure: GMTof EV-A71 neutralizing antibody on day 56 after vaccination
timeFrame: 56 days after vaccination
measure: Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination
timeFrame: 56 days after vaccination
measure: Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination
timeFrame: 56 days after vaccination
measure: Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination
timeFrame: 56 days after vaccination
measure: GMTof EV-A71 neutralizing antibody on month 13 after vaccination
timeFrame: 13 months after vaccination
measure: Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination
timeFrame: 13 months after vaccination
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Fengcai Zhu
Study officials:
References: