Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Hand, Foot and Mouth Disease
About this trial
This is an interventional prevention trial for Hand, Foot and Mouth Disease
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
Sites / Locations
- Fengcai Zhu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
the first batch vaccine producted by 40 L reactor
the second batch vaccine producted by 40 L reactor
the third batch vaccine producted by 40 L reactor
the first batch vaccine producted by 150 L reactor
the second batch vaccine producted by 150 L reactor
the third batch vaccine proudected by 150 L reactor
500 subjects will be randomly received the first batch vaccine producted by 40 L reactor
500 subjects will be randomly received the second batch vaccine producted by 40 L reactor
500 subjects will be randomly received the third batch vaccine producted by 40 L reactor
500 subjects will be randomly received the first batch vaccine producted by 150 L reactor
500 subjects will be randomly received the second batch vaccine producted by 150 L reactor
500 subjects will be randomly received the third batch vaccine producted by 150 L reactor