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Trial record 13 of 31 for:    sinovac | China

Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273233
First Posted: January 10, 2011
Last Update Posted: March 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
January 7, 2011
January 10, 2011
March 15, 2013
December 2010
February 2011   (Final data collection date for primary outcome measure)
To evaluate the safety and tolerability of the inactivated Enterovirus Type 71 Vaccine in adults by different doses [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT01273233 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults
A Blinded, Randomized and Controlled Clinical Trial of An Inactivated Enterovirus Type 71 Vaccine in Healthy Adults
A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type 71 Vaccines in healthy adults
A total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they will be randomized to receive two different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine in adults
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Infection; Viral, Enterovirus
  • Biological: Inactivated Enterovirus Type 71 Vaccine
    A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
    Other Name: EV71 Vaccine
  • Other: Placebo
    Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
    Other Name: EV71 Vaccine
  • Experimental: Group 1: 200U EV71 vaccine
    12 adults received 3 doses of 200U EV71 vaccine 14 days apart
    Intervention: Biological: Inactivated Enterovirus Type 71 Vaccine
  • Experimental: Group 2: 400U EV71 vaccine
    12 adults received 3 doses of 400U EV71 vaccine 14 days apart
    Intervention: Biological: Inactivated Enterovirus Type 71 Vaccine
  • Placebo Comparator: Group 1: Placebo
    6 adults received 3 doses of placebo 14 days apart
    Intervention: Other: Placebo
  • Placebo Comparator: Group 2: Placebo
    6 adults received 3 doses of placebo 14 days apart
    Intervention: Other: Placebo
Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
February 2011
February 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy males and females, aged from 18 to 49 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 are able to understand and sign informed consents.

Exclusion Criteria:

  1. Histroy of Hand-foot-mouth Disease
  2. Women of lactation, pregnancy or about to be pregnant in 60 days
  3. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
  4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  5. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
  6. Epilepsy, seizures or convulsions history, or family history of mental illness
  7. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
  8. History of asthma, angioedema, diabetes or malignancy
  9. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  10. 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
  11. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
  12. Acute illness or acute exacerbation of chronic disease within the past 7 days
  13. 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)
  14. History of any blood products within 3 months
  15. Administration of any live attenuated vaccine within 28 days
  16. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
  17. Axillary temperature > 37.0 centigrade before vaccination
  18. Abnormal laboratory parameters before vaccination
  19. 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
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01273233
EV71-1001-Ia
Yes
Not Provided
Not Provided
Sinovac Biotech Co., Ltd
Sinovac Biotech Co., Ltd
Not Provided
Principal Investigator: Yan-ping Li, MD Guangxi Centers for Disease Control and Prevention
Sinovac Biotech Co., Ltd
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP