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
  Purpose

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.


Condition Intervention Phase
Hand, Foot and Mouth Disease
Biological: 400U /0.5ml EV71 vaccine
Biological: 0/0.5ml placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Multicentered, Double - Blind, Randomized, and Placebo - Controlled Clinical Trial With Inactivated Enterovirus Type 71 (EV71) Vaccines

Resource links provided by NLM:


Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 10077
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: 0/0.5ml placebo in infants
0/0.5ml placebo in 5000 infants aged 6-35 months old on day0,28
Biological: 0/0.5ml placebo
0/0.5ml placebo, two doses, 28 days interval
Other Name: placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507857

Locations
China, Jiangsu
Ganyu
Lianyungang, Jiangsu, China
Taixing
Taizhou, Jiangsu, China
Sheyang CDC
Yancheng, Jiangsu, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Hua Wang, BS Jiangsu Center for Diseases Control and Prevention
  More Information

No publications provided by Sinovac Biotech Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01507857     History of Changes
Other Study ID Numbers: PRO-EV71-3001
Study First Received: January 2, 2012
Last Updated: November 27, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sinovac Biotech Co., Ltd:
EV71 vaccine
HFMD
efficacy
EV71 associated disease

Additional relevant MeSH terms:
Enterovirus Infections
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 20, 2014