InfluenzaPhase 1NCT00727428

Immunogenicity and Safety of GSK Biologicals' FluLaval® TF

A Phase 1 study testing FluLaval® TF in people with Influenza, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: FluLaval® TF
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteBelgium
Study dates: 5 Aug 2008to 17 Feb 2009
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 28Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: 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.

Conditions: Influenza
Being tested: FluLaval® TF
Keywords: FluLaval® TF, Safety, Immunogenicity, Influenza
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FluLaval® TFBiological
One IM injection.

Study groups in NCT00727428
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Biological: FluLaval® TF

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against each of the 3 vaccine influenza strains
Measured: Days 0 and 21
Seroconversion Rates (SCR)
Measured: Day 21
Seroprotection Rates (SPR)
Measured: Days 0 and 21
Seroconversion Factors (SCF)
Measured: Day 21

Secondary outcomes (3)

Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general signs and symptoms
Measured: 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
Measured: 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
Measured: During the entire study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 200817 Feb 2009

First posted4 Aug 2008 (estimated)
Study start5 Aug 2008
Primary completion29 Aug 2008
Study completion17 Feb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00727428
Sponsor's protocol ID: 112219
Status last verified: May 2017
First submitted: 1 Aug 2008
Last updated: 8 May 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT00727428
Acronym / sponsor ID: 112219
Conditions: Influenza
Keywords: FluLaval® TF, Safety, Immunogenicity, Influenza
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 5 Aug 2008 (actual)
Primary completion: 29 Aug 2008 (actual)
Study completion: 17 Feb 2009 (actual)
First posted: 4 Aug 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Group A	Experimental	Biological: FluLaval® TF

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (28 listed)

Acute disease at the time of enrollment.
Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:
Any confirmed or suspected immunosuppressive condition including:
History of renal impairment.
History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FluLaval® TFOne IM injection.	Biological	Group A

Primary outcome

Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against each of the 3 vaccine influenza strains
Time frame: Days 0 and 21
Seroconversion Rates (SCR)
Time frame: Day 21
Seroprotection Rates (SPR)
Time frame: Days 0 and 21
Seroconversion Factors (SCF)
Time frame: Day 21

3 secondary outcomes

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.
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.
Occurrence, intensity and investigator's assessment of relationship to vaccine of SAEs and medically attended events
Time frame: During the entire study period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
Results for study 112219 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FluLaval® TF in people with Influenza, run by GlaxoSmithKline at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against each of the 3 vaccine influenza strains (time frame: Days 0 and 21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00727428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.