Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine

April 16, 2008 updated by: Sinovac Biotech Co., Ltd

Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial

A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).

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.

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.
57

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 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
    • Beijing
      • Beijing, Beijing, China
        • China-Japan Friendship Hospital

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

19 years to 61 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Had received two-dose priming vaccination in previous phase I trial
  • Be able to show legal identity card for the sake of recruitment
  • Be able to understand and sign the informed consent.

Exclusion Criteria:

  • Woman： Who breast-feeding or planning to become pregnant during the study
  • Any history of allergic reactions to vaccines or eggs
  • Autoimmune disease or immunodeficiency
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes
  • Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  • Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
  • Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
  • Guillain-Barre Syndrome
  • Women subjects with positive urinary pregnancy test
  • Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months
  • History of any blood products administration within 3 months before the dosing
  • Administration of any other investigational research agents within 30 days before the dosing
  • Administration of any live attenuated vaccine within 30 days before the dosing
  • Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
  • Be receiving anti-TB prophylaxis or therapy currently
  • Axillary temperature >37.0 centigrade at the time of dosing
  • Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
  • 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: Non-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: No.1: 1.25 ug
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
Experimental: No.2: 2.5 ug
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
Experimental: No.3: 5.0 ug
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
Experimental: No. 4: 10 ug
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection

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
Time Frame
HI antibody Neutralization antibody
Time Frame: 15 and 30 days after the booster dose
15 and 30 days after the booster dose

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
Time Frame
local adverse reactions systemic adverse reactions temperature
Time Frame: 3 days after booster dose
3 days after booster dose

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention, China

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.
January 1, 2007

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.
March 1, 2007

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.
March 1, 2008

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).
April 15, 2008

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.
April 16, 2008

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.
April 17, 2008

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.
April 17, 2008

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.
April 16, 2008

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.
April 1, 2008

More Information

Terms related to this study

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-PanFlu-1002

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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