Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

March 13, 2013 updated by: Sinovac Biotech Co., Ltd

A Blinded, Randomized and Controlled Clinical Trial of An Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type 71 Vaccines in healthy adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they will be randomized to receive two different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine in adults

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China
        • GuangXi Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy males and females, aged from 18 to 49 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 are able to understand and sign informed consents.

Exclusion Criteria:

  1. Histroy of Hand-foot-mouth Disease
  2. Women of lactation, pregnancy or about to be pregnant in 60 days
  3. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
  4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  5. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
  6. Epilepsy, seizures or convulsions history, or family history of mental illness
  7. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
  8. History of asthma, angioedema, diabetes or malignancy
  9. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  10. 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
  11. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
  12. Acute illness or acute exacerbation of chronic disease within the past 7 days
  13. 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)
  14. History of any blood products within 3 months
  15. Administration of any live attenuated vaccine within 28 days
  16. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
  17. Axillary temperature > 37.0 centigrade before vaccination
  18. Abnormal laboratory parameters before vaccination
  19. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: 200U EV71 vaccine
12 adults received 3 doses of 200U EV71 vaccine 14 days apart
Biological: Inactivated Enterovirus Type 71 Vaccine
A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
Other Names:
  • EV71 Vaccine
Experimental: Group 2: 400U EV71 vaccine
12 adults received 3 doses of 400U EV71 vaccine 14 days apart
Biological: Inactivated Enterovirus Type 71 Vaccine
A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
Other Names:
  • EV71 Vaccine
Placebo Comparator: Group 1: Placebo
6 adults received 3 doses of placebo 14 days apart
Other: Placebo
Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
Other Names:
  • EV71 Vaccine
Placebo Comparator: Group 2: Placebo
6 adults received 3 doses of placebo 14 days apart
Other: Placebo
Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
Other Names:
  • EV71 Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of the inactivated Enterovirus Type 71 Vaccine in adults by different doses
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac Biotech Co., Ltd

Investigators

  • Principal Investigator: Yan-ping Li, MD, Guangxi Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EV71-1001-Ia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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