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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01636245
First received: July 5, 2012
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Hand, Foot and Mouth Disease
Biological: three consecutive lots of EV71 vaccine
Biological: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen [ Time Frame: 28 days after first vaccination ] [ Designated as safety issue: No ]
    to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination


Secondary Outcome Measures:
  • Frequency of systemic and local adverse reactions after the first vaccination [ Time Frame: 28 days after the first vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 28 days after the second vaccination ] [ Designated as safety issue: Yes ]
    Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine


Enrollment: 1400
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lot 1
inactivated vaccine (Lot 1) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
Biological: three consecutive lots of EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Other Name: Vaccine groups
Experimental: Lot 2
inactivated vaccine (Lot 2) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
Biological: three consecutive lots of EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Other Name: Vaccine groups
Experimental: Lot 3
inactivated vaccine (Lot 3) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
Biological: three consecutive lots of EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Other Name: Vaccine groups
Placebo Comparator: Placebo
Placebo in 350 infants aged 6 months to 5 years old on day 0,28
Biological: placebo
placebo, two doses, 28 days interval
Other Name: Control group

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636245

Locations
China, Jiangsu
Jurong
ZhenJiang, Jiangsu, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Yue-Mei Hu, BS Jiangsu Center for Diseases Control and Prevention
  More Information

No publications provided by Sinovac Biotech Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01636245     History of Changes
Other Study ID Numbers: PRO-EV71-3002
Study First Received: July 5, 2012
Last Updated: March 13, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sinovac Biotech Co., Ltd:
71 vaccine
HFMD
consistency of three consecutive lots
immunogenicity

Additional relevant MeSH terms:
Enterovirus Infections
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 14, 2014