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CompletedNCT01507857Updated Nov 28, 2013

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

A Phase 3 interventional study of 400U /0.5ml EV71 vaccine and 0/0.5ml placebo in Hand, Foot and Mouth Disease, sponsored by Sinovac Biotech Co., Ltd. Completed at 3 sites in China. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-28.

Sponsored by Sinovac Biotech Co., Ltd · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
10,077
Allocation
Randomized
Ages
6 Months to 35 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hand, Foot and Mouth Disease

Keywords

  • EV71 vaccine
  • HFMD
  • efficacy
  • EV71 associated disease
03

In context

Foot-and-Mouth Disease

46 studies on the registry are indexed under Foot-and-Mouth Disease; 6 are open to participants now.

This study's enrollment of 10,077 is above the median of 410 across 38 interventional studies indexed under Foot-and-Mouth Disease.

Browse Foot-and-Mouth Disease studies →

Lead sponsor

Sinovac Biotech Co., Ltd is the lead sponsor of 89 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 35 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
10,077 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Biological400U /0.5ml EV71 vaccine

    inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval

    Also known as: EV71 vaccine

  • Biological0/0.5ml placebo

    0/0.5ml placebo, two doses, 28 days interval

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From 28 days after the second vaccination to one year

Secondary outcomes

  1. 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

    Time frame: 28 days after first vaccination

  2. 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

    Time frame: 7 and 13 months after second vaccination

  3. 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

    Time frame: 28 days after the first vaccination

  4. 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

    Time frame: 28 days after the second vaccination

07

Study locations

3 sites
  • Ganyu
    Lianyungang, Jiangsu, China
  • Taixing
    Taizhou, Jiangsu, China
  • Sheyang CDC
    Yancheng, Jiangsu, China
08

References and documents

Publications

  • 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. PubMed 24571754 ↗
  • 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. PubMed 22992566 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01507857
Lead sponsor
Sinovac Biotech Co., Ltd
Responsible party
Sponsor
First posted
Jan 11, 2012
Start date
Jan 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Nov 28, 2013

Study contacts

Hua Wang, BS
principal investigator · Jiangsu Center for Diseases Control and Prevention

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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