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Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

This study has been completed.
Sponsor:
Information provided by:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01273246
First received: January 7, 2011
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).


Condition Intervention Phase
Hand-foot-mouth Disease
Infection; Viral, Enterovirus
 Biological: 100U inactivated Enterovirus Type 71 Vaccine
Biological: 200U inactivated Enterovirus Type 71 Vaccine
Biological: 400U inactivated Enterovirus Type 71 Vaccine
Biological: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    All adverse events were records. Blood cell and biochemistry were performed.


Secondary Outcome Measures:
  • To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    virus neutralization assays were performed.


Enrollment: 132
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Children Group 1: 200U EV71 vaccine
12 children received 3 doses of 200U EV71 vaccine 28 days apart
 Biological: 200U inactivated Enterovirus Type 71 Vaccine
Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: EV71 vaccine
Placebo Comparator: Children Group 1: Placebo
6 children received 3 doses of placebo 28 days apart
 Biological: Placebo
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: Placebo
Experimental: Children Group 2: 400U EV71 vaccine
12 children received 3 doses of 400U EV71 vaccine 28 days apart
 Biological: 400U inactivated Enterovirus Type 71 Vaccine
Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: EV71 vaccine
Placebo Comparator: Children Group 2: Placebo
6 children received 3 doses of placebo 28 days apart
 Biological: Placebo
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: Placebo
Experimental: Infants Group 1: 100U EV71 vaccine
24 infants received 3 doses of 100U EV71 vaccine 28 days apart
 Biological: 100U inactivated Enterovirus Type 71 Vaccine
Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: EV71 vaccine
Placebo Comparator: Infants Group 1: Placebo
8 infants received 3 doses of placebo 28 days apart
 Biological: Placebo
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: Placebo
Experimental: Infants Group 2: 200U EV71 vaccine
24 infants received 3 doses of 200U EV71 vaccine 28 days apart
 Biological: 200U inactivated Enterovirus Type 71 Vaccine
Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: EV71 vaccine
Placebo Comparator: Infants Group 2: Placebo
8 infants received 3 doses of placebo 28 days apart
 Biological: Placebo
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: Placebo
Experimental: Infants Group 3: 400U EV71 vaccine
24 infants received 3 doses of 400U EV71 vaccine 28 days apart
 Biological: 400U inactivated Enterovirus Type 71 Vaccine
Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: EV71 vaccine
Placebo Comparator: Infants Group 3: Placebo
8 infants received 3 doses of placebo 28 days apart
 Biological: Placebo
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Name: Placebo

Detailed Description:

36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine

  Eligibility

Ages Eligible for Study:   6 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Provided legal identification for the sake of recruitment.
  3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
  4. Birth weight more than 2500 grams

Exclusion Criteria:

  1. Histroy of Hand-foot-mouth Disease
  2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
  3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
  5. Epilepsy, seizures or convulsions history, or family history of mental illness
  6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
  7. History of asthma, angioedema, diabetes or malignancy
  8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  9. 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
  10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
  11. Acute illness or acute exacerbation of chronic disease within the past 7 days
  12. 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)
  13. History of any blood products within 3 months
  14. Administration of any live attenuated vaccine within 28 days
  15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
  16. Axillary temperature > 37.0 centigrade before vaccination
  17. Abnormal laboratory parameters before vaccination
  18. 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: NCT01273246

Locations
China, Guangxi
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Yan-pin Li, MD Guangxi Centers for Disease 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: Wei-Dong Yin, Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01273246     History of Changes
Other Study ID Numbers: EV71-1001-Ib
Study First Received: January 7, 2011
Last Updated: July 21, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013