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

Hand, Foot and Mouth Disease Clinical Trial

Official title:

A Multicentered, Double - Blind, Randomized, and Placebo - Controlled Clinical Trial With Inactivated Enterovirus Type 71 (EV71) Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507857
• Other study ID #: PRO-EV71-3001
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2012
• Last updated: November 27, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10077
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Biological:
• 400U /0.5ml EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
• 0/0.5ml placebo
0/0.5ml placebo, two doses, 28 days interval

Locations

Country	Name	City	State
China	Ganyu	Lianyungang	Jiangsu
China	Taixing	Taizhou	Jiangsu
China	Sheyang CDC	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	28 days after first vaccination	No
Secondary	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	7 and 13 months after second vaccination	No
Secondary	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	28 days after the first vaccination	Yes
Secondary	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	28 days after the second vaccination	Yes