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

NCT01507857 | Completed Phase 3 DMC

• 1 other identifier: PRO-EV71-3001
• Study Type: interventional
• Target: 10,077
• Locations: 1 country
• Sites: 3

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.

Conditions

Hand, Foot and Mouth Disease

Keywords

EV71 vaccine; HFMD; efficacy; EV71 associated disease

Outcome Measures

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

  From 28 days after the second vaccination to one year

Secondary Outcomes (4)

• The GMT of anti-EV71 antibodies in serum after second vaccination

  28 days after first vaccination

• The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination

  7 and 13 months after second vaccination

• Frequency of systemic and local adverse reactions after the first vaccination

  28 days after the first vaccination

• Frequency of systemic and local adverse reactions after the second vaccination

  28 days after the second vaccination

Study Arms (2)

400U /0.5ml in infants

EXPERIMENTAL

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

0/0.5ml placebo in infants

PLACEBO COMPARATOR

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

Biological: 0/0.5ml placebo

Interventions

400U /0.5ml EV71 vaccine BIOLOGICAL

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

Also known as: EV71 vaccine

400U /0.5ml in infants

0/0.5ml placebo BIOLOGICAL

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

Also known as: placebo

0/0.5ml placebo in infants

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (3)

Ganyu

Lianyungang, Jiangsu, China

Location

Taixing

Taizhou, Jiangsu, China

Location

Sheyang CDC

Yancheng, Jiangsu, China

Location

Related Publications (2)

• 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.

  PMID: 24571754 DERIVED

• 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.

  PMID: 22992566 DERIVED

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Hua Wang, BS

  Jiangsu Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 11, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 28, 2013

Record last verified: 2013-03

Locations

CN (3)