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An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01507857
First received: January 2, 2012
Last updated: November 27, 2013
Last verified: March 2013

January 2, 2012
November 27, 2013
January 2012
March 2013   (final data collection date for primary outcome measure)
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination [ Time Frame: From 28 days after the second vaccination to one year ] [ Designated as safety issue: No ]
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Same as current
Complete list of historical versions of study NCT01507857 on ClinicalTrials.gov Archive Site
  • The GMT of anti-EV71 antibodies in serum after second vaccination [ Time Frame: 28 days after first vaccination ] [ Designated as safety issue: No ]
    to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination
  • The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination [ Time Frame: 7 and 13 months after second vaccination ] [ Designated as safety issue: No ]
    to evaluate the immune persistence of anti-EV71 antibodies in serum
  • Frequency of systemic and local adverse reactions after the first vaccination [ Time Frame: 28 days after the first vaccination ] [ Designated as safety issue: Yes ]
    Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine
  • Frequency of systemic and local adverse reactions after the second vaccination [ Time Frame: 28 days after the second vaccination ] [ Designated as safety issue: Yes ]
    Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine
Same as current
Not Provided
Not Provided
 
An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
A Multicentered, Double - Blind, Randomized, and Placebo - Controlled Clinical Trial With Inactivated Enterovirus Type 71 (EV71) Vaccines

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

The phase II study of inactivated vaccine (vero cell) against EV71 has completed on Dec 2011 in China. The data from the phase I and II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. In order to evaluate the efficacy of the vaccine against Hand, Foot and Mouth disease caused by EV71, and to further explore the safety profile of this vaccine in expending infant population, a phase III clinical trial is planed to conduct.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Hand, Foot and Mouth Disease
  • Biological: 400U /0.5ml EV71 vaccine
    inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
    Other Name: EV71 vaccine
  • Biological: 0/0.5ml placebo
    0/0.5ml placebo, two doses, 28 days interval
    Other Name: placebo
  • Experimental: 400U /0.5ml in infants
    inactivated vaccine(vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
    Intervention: Biological: 400U /0.5ml EV71 vaccine
  • Placebo Comparator: 0/0.5ml placebo in infants
    0/0.5ml placebo in 5000 infants aged 6-35 months old on day0,28
    Intervention: Biological: 0/0.5ml placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10077
March 2013
March 2013   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • 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 14 days
  • Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 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
Both
6 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01507857
PRO-EV71-3001
Yes
Sinovac Biotech Co., Ltd
Sinovac Biotech Co., Ltd
Not Provided
Principal Investigator: Hua Wang, BS Jiangsu Center for Diseases 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