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Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

This study has been completed.
Sponsor:
Information provided by:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01273246
First received: January 7, 2011
Last updated: July 21, 2011
Last verified: July 2011

January 7, 2011
July 21, 2011
January 2011
June 2011   (final data collection date for primary outcome measure)
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
All adverse events were records. Blood cell and biochemistry were performed.
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01273246 on ClinicalTrials.gov Archive Site
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
virus neutralization assays were performed.
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.

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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • Hand-foot-mouth Disease
  • Infection; Viral, Enterovirus
  • 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
    Other Name: EV71 vaccine
  • Biological: 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
    Other Name: EV71 vaccine
  • Biological: 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
    Other Name: EV71 vaccine
  • Biological: 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
    Other Name: Placebo
  • Experimental: Children Group 1: 200U EV71 vaccine
    12 children received 3 doses of 200U EV71 vaccine 28 days apart
    Intervention: Biological: 200U inactivated Enterovirus Type 71 Vaccine
  • Placebo Comparator: Children Group 1: Placebo
    6 children received 3 doses of placebo 28 days apart
    Intervention: Biological: Placebo
  • Experimental: Children Group 2: 400U EV71 vaccine
    12 children received 3 doses of 400U EV71 vaccine 28 days apart
    Intervention: Biological: 400U inactivated Enterovirus Type 71 Vaccine
  • Placebo Comparator: Children Group 2: Placebo
    6 children received 3 doses of placebo 28 days apart
    Intervention: Biological: Placebo
  • Experimental: Infants Group 1: 100U EV71 vaccine
    24 infants received 3 doses of 100U EV71 vaccine 28 days apart
    Intervention: Biological: 100U inactivated Enterovirus Type 71 Vaccine
  • Placebo Comparator: Infants Group 1: Placebo
    8 infants received 3 doses of placebo 28 days apart
    Intervention: Biological: Placebo
  • Experimental: Infants Group 2: 200U EV71 vaccine
    24 infants received 3 doses of 200U EV71 vaccine 28 days apart
    Intervention: Biological: 200U inactivated Enterovirus Type 71 Vaccine
  • Placebo Comparator: Infants Group 2: Placebo
    8 infants received 3 doses of placebo 28 days apart
    Intervention: Biological: Placebo
  • Experimental: Infants Group 3: 400U EV71 vaccine
    24 infants received 3 doses of 400U EV71 vaccine 28 days apart
    Intervention: Biological: 400U inactivated Enterovirus Type 71 Vaccine
  • Placebo Comparator: Infants Group 3: Placebo
    8 infants received 3 doses of placebo 28 days apart
    Intervention: Biological: 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
132
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 11 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01273246
EV71-1001-Ib
Yes
Wei-Dong Yin, Sinovac Biotech Co., Ltd
Sinovac Biotech Co., Ltd
Not Provided
Principal Investigator: Yan-pin Li, MD Guangxi Centers for Disease Control and Prevention
Sinovac Biotech Co., Ltd
July 2011

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