Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

Study Overview
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Brief Summary
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A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).

Detailed Description
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36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine

Official Title
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A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.

Conditions
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Hand-foot-mouth Disease, Infection; Viral, Enterovirus

Intervention / Treatment
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* Biological: 100U inactivated Enterovirus Type 71 Vaccine
* Biological: 200U inactivated Enterovirus Type 71 Vaccine
* Biological: 400U inactivated Enterovirus Type 71 Vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children Group 1: 200U EV71 vaccine<br>12 children received 3 doses of 200U EV71 vaccine 28 days apart | Biological: 200U inactivated Enterovirus Type 71 Vaccine<br>* Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>* Other names: EV71 vaccine;|
| Placebo Comparator: Children Group 1: Placebo<br>6 children received 3 doses of placebo 28 days apart | Biological: Placebo<br>* Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>|
| Experimental: Children Group 2: 400U EV71 vaccine<br>12 children received 3 doses of 400U EV71 vaccine 28 days apart | Biological: 400U inactivated Enterovirus Type 71 Vaccine<br>* Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>* Other names: EV71 vaccine;|
| Placebo Comparator: Children Group 2: Placebo<br>6 children received 3 doses of placebo 28 days apart | Biological: Placebo<br>* Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>|
| Experimental: Infants Group 1: 100U EV71 vaccine<br>24 infants received 3 doses of 100U EV71 vaccine 28 days apart | Biological: 100U inactivated Enterovirus Type 71 Vaccine<br>* Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>* Other names: EV71 vaccine;|
| Placebo Comparator: Infants Group 1: Placebo<br>8 infants received 3 doses of placebo 28 days apart | Biological: Placebo<br>* Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>|
| Experimental: Infants Group 2: 200U EV71 vaccine<br>24 infants received 3 doses of 200U EV71 vaccine 28 days apart | Biological: 200U inactivated Enterovirus Type 71 Vaccine<br>* Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>* Other names: EV71 vaccine;|
| Placebo Comparator: Infants Group 2: Placebo<br>8 infants received 3 doses of placebo 28 days apart | Biological: Placebo<br>* Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>|
| Experimental: Infants Group 3: 400U EV71 vaccine<br>24 infants received 3 doses of 400U EV71 vaccine 28 days apart | Biological: 400U inactivated Enterovirus Type 71 Vaccine<br>* Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>* Other names: EV71 vaccine;|
| Placebo Comparator: Infants Group 3: Placebo<br>8 infants received 3 doses of placebo 28 days apart | Biological: Placebo<br>* Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine | All adverse events were records. Blood cell and biochemistry were performed. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine | virus neutralization assays were performed. | 6 months |