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

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

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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
    • Jiangsu
      • ZhenJiang, Jiangsu, China
        • Jurong

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
Time Frame: 28 days after first vaccination
to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination
28 days after first vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of systemic and local adverse reactions after the first vaccination
Time Frame: 28 days 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
Frequency of systemic and local adverse reactions after the second vaccination
Time Frame: 28 days 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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Biotech Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yue-Mei Hu, BS, Jiangsu Center for Diseases 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-EV71-3002

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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