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

Primary Purpose

Hand, Foot and Mouth Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
400U /0.5ml EV71 vaccine
0/0.5ml placebo
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand, Foot and Mouth Disease focused on measuring EV71 vaccine, HFMD, efficacy, EV71 associated disease

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ganyu
  • Taixing
  • Sheyang CDC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

400U /0.5ml in infants

0/0.5ml placebo in infants

Arm Description

inactivated vaccine(vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28

0/0.5ml placebo in 5000 infants aged 6-35 months old on day0,28

Outcomes

Primary Outcome Measures

The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination
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
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
to evaluate the immune persistence of anti-EV71 antibodies in serum
Frequency of systemic and local adverse reactions after the first vaccination
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
Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine

Full Information

First Posted
January 2, 2012
Last Updated
November 27, 2013
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01507857
Brief Title
An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Official Title
A Multicentered, Double - Blind, Randomized, and Placebo - Controlled Clinical Trial With Inactivated Enterovirus Type 71 (EV71) Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot and Mouth Disease
Keywords
EV71 vaccine, HFMD, efficacy, EV71 associated disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10077 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400U /0.5ml in infants
Arm Type
Experimental
Arm Description
inactivated vaccine(vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
Arm Title
0/0.5ml placebo in infants
Arm Type
Placebo Comparator
Arm Description
0/0.5ml placebo in 5000 infants aged 6-35 months old on day0,28
Intervention Type
Biological
Intervention Name(s)
400U /0.5ml EV71 vaccine
Other Intervention Name(s)
EV71 vaccine
Intervention Description
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Intervention Type
Biological
Intervention Name(s)
0/0.5ml placebo
Other Intervention Name(s)
placebo
Intervention Description
0/0.5ml placebo, two doses, 28 days interval
Primary Outcome Measure Information:
Title
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination
Description
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Time Frame
From 28 days after the second vaccination to one year
Secondary Outcome Measure Information:
Title
The GMT of anti-EV71 antibodies in serum after second vaccination
Description
to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination
Time Frame
28 days after first vaccination
Title
The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination
Description
to evaluate the immune persistence of anti-EV71 antibodies in serum
Time Frame
7 and 13 months after second vaccination
Title
Frequency of systemic and local adverse reactions after the first vaccination
Description
Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine
Time Frame
28 days after the first vaccination
Title
Frequency of systemic and local adverse reactions after the second vaccination
Description
Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine
Time Frame
28 days after the second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Wang, BS
Organizational Affiliation
Jiangsu Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ganyu
City
Lianyungang
State/Province
Jiangsu
Country
China
Facility Name
Taixing
City
Taizhou
State/Province
Jiangsu
Country
China
Facility Name
Sheyang CDC
City
Yancheng
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24571754
Citation
Zhu F, Xu W, Xia J, Liang Z, Liu Y, Zhang X, Tan X, Wang L, Mao Q, Wu J, Hu Y, Ji T, Song L, Liang Q, Zhang B, Gao Q, Li J, Wang S, Hu Y, Gu S, Zhang J, Yao G, Gu J, Wang X, Zhou Y, Chen C, Zhang M, Cao M, Wang J, Wang H, Wang N. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med. 2014 Feb 27;370(9):818-28. doi: 10.1056/NEJMoa1304923.
Results Reference
derived
PubMed Identifier
22992566
Citation
Chong P, Hsieh SY, Liu CC, Chou AH, Chang JY, Wu SC, Liu SJ, Chow YH, Su IJ, Klein M. Production of EV71 vaccine candidates. Hum Vaccin Immunother. 2012 Dec 1;8(12):1775-83. doi: 10.4161/hv.21739. Epub 2012 Sep 19.
Results Reference
derived

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

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