Immunogenicity and Safety of GSK Biologicals' FluLaval® TF

May 5, 2017 updated by: GlaxoSmithKline

Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral®, Thimerosal-free (FluLaval® TF), in Adults 18 to 60 Years of Age.

The present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives & outcome measures of the primary phase/study.

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.
110

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

  • Belgium
      • Gent, Belgium, 9000
        • GSK Investigational Site

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • Male and female adults, 18 to 60 years of age.
  • Written informed consent obtained from the subject.
  • Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical or psychiatric conditions).
  • Access to a consistent means of telephone contact, which may be either in the home or at workplace, land line or mobile, but not a pay phone or other multiple-user device.

Exclusion Criteria:

  • Acute disease at the time of enrollment.

  • Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:

    • Requiring institution of new medical or surgical treatment within 1 month prior to study enrollment, or
    • Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or
    • Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
    • Hospitalization or an event fulfilling the definition of a SAE within 1 month prior to study enrollment.

  • Any confirmed or suspected immunosuppressive condition including:

    • History of human immunodeficiency virus (HIV) infection,
    • Cancer or treatment for cancer, within 3 years of study enrollment.
  • History of renal impairment.
  • History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
  • Complicated insulin-dependent diabetes mellitus.
  • Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
  • Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
  • Receipt of systemic glucocorticoidswithin 1 month of study enrollment, or chronic use of any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.
  • History of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
  • Presence of an active neurological disorder.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin
  • Receipt of an influenza vaccine during the 2007-8 influenza immunization season.
  • Administration of any vaccines within 30 days prior to study enrollment or during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or planned during the study.
  • Any known or suspected allergy to any constituent of FluLaval and/or any flu vaccines and/or history of anaphylactic-type reaction to consumption of eggs.
  • A history of severe adverse reaction to a previous influenza vaccination.
  • If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
  • Lactating/nursing female.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Group A
Biological: FluLaval® TF
One IM 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
Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against each of the 3 vaccine influenza strains
Time Frame: Days 0 and 21
Days 0 and 21
Seroconversion Rates (SCR)
Time Frame: Day 21
Day 21
Seroprotection Rates (SPR)
Time Frame: Days 0 and 21
Days 0 and 21
Seroconversion Factors (SCF)
Time Frame: Day 21
Day 21

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
Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general signs and symptoms
Time Frame: During the 4-day follow-up period after vaccination.
During the 4-day follow-up period after vaccination.
Occurrence, intensity, and investigator's assessment of relationship to vaccine of unsolicited local and general signs and symptoms
Time Frame: During the 21-day follow-up period after vaccination.
During the 21-day follow-up period after vaccination.
Occurrence, intensity and investigator's assessment of relationship to vaccine of SAEs and medically attended events
Time Frame: During the entire study period
During the entire study period

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.
GlaxoSmithKline

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 (Actual)

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.
August 5, 2008

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.
August 29, 2008

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 17, 2009

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).
August 1, 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.
August 1, 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.
August 4, 2008

Study Record Updates

Last Update Posted (Actual)

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.
May 8, 2017

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.
May 5, 2017

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.
May 1, 2017

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.
  • 112219

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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