Status:
COMPLETED
Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Infection, Viral, Enterovirus
Eligibility:
All Genders
6-35 years
Phase:
PHASE2
Brief Summary
A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.
Eligibility Criteria
Inclusion
- 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
- History 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT01421121
Start Date
June 1 2011
End Date
December 1 2011
Last Update
November 27 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China