Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
Hand-foot-mouth Disease, Infection; Viral, Enterovirus
About this trial
This is an interventional prevention trial for Hand-foot-mouth Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
- Provided legal identification for the sake of recruitment.
- Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
- Birth weight more than 2500 grams
Exclusion Criteria:
- Histroy of Hand-foot-mouth Disease
- Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
- Epilepsy, seizures or convulsions history, or family history of mental illness
- Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
- History of asthma, angioedema, diabetes or malignancy
- History of thyroidectomy or thyroid disease that required medication within the past 12 months
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
- Acute illness or acute exacerbation of chronic disease within the past 7 days
- Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- History of any blood products within 3 months
- Administration of any live attenuated vaccine within 28 days
- Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
- Axillary temperature > 37.0 centigrade before vaccination
- Abnormal laboratory parameters before vaccination
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Sites / Locations
- GuangXi Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Children Group 1: 200U EV71 vaccine
Children Group 1: Placebo
Children Group 2: 400U EV71 vaccine
Children Group 2: Placebo
Infants Group 1: 100U EV71 vaccine
Infants Group 1: Placebo
Infants Group 2: 200U EV71 vaccine
Infants Group 2: Placebo
Infants Group 3: 400U EV71 vaccine
Infants Group 3: Placebo
12 children received 3 doses of 200U EV71 vaccine 28 days apart
6 children received 3 doses of placebo 28 days apart
12 children received 3 doses of 400U EV71 vaccine 28 days apart
6 children received 3 doses of placebo 28 days apart
24 infants received 3 doses of 100U EV71 vaccine 28 days apart
8 infants received 3 doses of placebo 28 days apart
24 infants received 3 doses of 200U EV71 vaccine 28 days apart
8 infants received 3 doses of placebo 28 days apart
24 infants received 3 doses of 400U EV71 vaccine 28 days apart
8 infants received 3 doses of placebo 28 days apart