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Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine

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ClinicalTrials.gov Identifier: NCT01636245
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Study Description
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Brief Summary:
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Biological: three consecutive lots of EV71 vaccine Biological: placebo Phase 3

Detailed Description:
The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : February 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Lot 1
inactivated vaccine (Lot 1) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
 Biological: three consecutive lots of EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Other Name: Vaccine groups
Experimental: Lot 2
inactivated vaccine (Lot 2) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
 Biological: three consecutive lots of EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Other Name: Vaccine groups
Experimental: Lot 3
inactivated vaccine (Lot 3) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
 Biological: three consecutive lots of EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Other Name: Vaccine groups
Placebo Comparator: Placebo
Placebo in 350 infants aged 6 months to 5 years old on day 0,28
 Biological: placebo
placebo, two doses, 28 days interval
Other Name: Control group


Outcome Measures
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Primary Outcome Measures :
  1. The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen [ Time Frame: 28 days after first vaccination ]
    to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination


Secondary Outcome Measures :
  1. Frequency of systemic and local adverse reactions after the first vaccination [ Time Frame: 28 days after the first vaccination ]
    Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine

  2. Frequency of systemic and local adverse reactions after the second vaccination [ Time Frame: 28 days after the second vaccination ]
    Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636245


Locations
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China, Jiangsu
Jurong
ZhenJiang, Jiangsu, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Yue-Mei Hu, BS Jiangsu Center for Diseases Control and Prevention
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01636245    
Other Study ID Numbers: PRO-EV71-3002
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by Sinovac Biotech Co., Ltd:
71 vaccine
HFMD
consistency of three consecutive lots
immunogenicity
Additional relevant MeSH terms:
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Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Stomatognathic Diseases
Coxsackievirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs