Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine

Hand, Foot and Mouth Disease Clinical Trial

Official title:

Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636245
• Other study ID #: PRO-EV71-3002
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2012
• Last updated: March 13, 2013
• Start date: July 2012
• Est. completion date: February 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 immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.

Description:

The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 5 Years

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

Locations

Country	Name	City	State
China	Jurong	ZhenJiang	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 GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen	to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination	28 days after first 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