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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01273246
Other study ID # EV71-1001-Ib
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2011
Est. completion date July 2011

Study information

Verified date July 2011
Source Sinovac Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date July 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 11 Years
Eligibility Inclusion Criteria: 1. 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 2. Provided legal identification for the sake of recruitment. 3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents. 4. Birth weight more than 2500 grams Exclusion Criteria: 1. Histroy of Hand-foot-mouth Disease 2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine 3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition 5. Epilepsy, seizures or convulsions history, or family history of mental illness 6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency 7. History of asthma, angioedema, diabetes or malignancy 8. History of thyroidectomy or thyroid disease that required medication within the past 12 months 9. 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 10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen 11. Acute illness or acute exacerbation of chronic disease within the past 7 days 12. 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) 13. History of any blood products within 3 months 14. Administration of any live attenuated vaccine within 28 days 15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days 16. Axillary temperature > 37.0 centigrade before vaccination 17. Abnormal laboratory parameters before vaccination 18. 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

Study Design


Intervention

Biological:
100U inactivated Enterovirus Type 71 Vaccine
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
200U inactivated Enterovirus Type 71 Vaccine
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
400U inactivated Enterovirus Type 71 Vaccine
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
Placebo
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

Locations

Country Name City State
China GuangXi Center for Diseases Control and Prevention Nanning Guangxi

Sponsors (1)

Lead Sponsor Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine virus neutralization assays were performed. 6 months
See also
  Status Clinical Trial Phase
Completed NCT01273233 - Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults Phase 1