InfluenzaPhase 3NCT01878825

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older

A Phase 3 study testing Fluviral™ in people with Influenza, run by GlaxoSmithKline at 1 site in Canada.

Completed

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

Trial summary

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults aged 18 years and older. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluviral™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteCanada
Study dates: 18 Jul 2013to 9 Aug 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female 18 years of age and older at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well-controlled chronic disease, as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

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Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination dose.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab etc.) within 6 months before study start, or planned administration during the study period.
Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period.
Clinically or virologically confirmed influenza infection within the 6 months preceding the study vaccination.

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Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required):
History of human immunodeficiency virus (HIV) infection,
Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
Acute disease and/or fever at the time of enrollment.
Acute disease is defined as the presence of a short term, moderate or severe illness, with or without fever.
Fever is defined as temperature ≥ 38.0°C/100.4°F for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral.
Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness. "Uncontrolled" is defined as:
Requiring institution of new medical or surgical treatment within one 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 one month prior to study enrollment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Subjects who participated in the registration trial [116664 (FLU Q-TIV-014)] for Fluviral™ 2012/2013 conducted in the 2012-2013 season.
Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
Any known or suspected allergy to any constituent of Fluviral™ and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
A history of severe adverse reaction to a previous influenza vaccination.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study or would make the intramuscular injection unsafe.

Trial locations and contacts

1 site in 1 country.

Canada1 site

GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1

Other trials in Canada

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older

Conditions: Influenza
Being tested: Fluviral™
Keywords: Immunogenicity, Trivalent, Safety, Adults, Elderly, 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.

Fluviral™Biological
1 dose administered intramuscularly in deltoid region of non-dominant arm.

Study groups in NCT01878825
Study group	Role	What they receive
Fluviral 18-60 Years Group	Experimental	Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluviral™
Fluviral >60 Years Group	Experimental	Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm Receives: Biological: Fluviral™

What is being measured

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

Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Measured: At Days 0 and 21
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Measured: At Day 21
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Measured: At Day 21
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Measured: At Days 0 and Day 21

Secondary outcomes (8)

Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.
Measured: At Days 0 and Day 21
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.
Measured: At Day 21
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.
Measured: At Day 21
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.
Measured: At Day 0 and Day 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [oral temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Measured: During the 21-day (Days 0-20) post-vaccination period
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Measured: During the entire study period (Days 0-20 post vaccination)

Timeline

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

18 Jul 20139 Aug 2013

First posted17 Jun 2013 (estimated)
Study start18 Jul 2013
Primary completion9 Aug 2013
Study completion9 Aug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01878825
Sponsor's protocol ID: 200190
Status last verified: Jun 2018
First submitted: 13 Jun 2013
Last updated: 7 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. 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 (GSK1536489A) Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older
ClinicalTrials.gov ID: NCT01878825
Acronym / sponsor ID: 200190
Conditions: Influenza
Keywords: Immunogenicity, Trivalent, Safety, Adults, Elderly, Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 18 Jul 2013
Primary completion: 9 Aug 2013 (actual)
Study completion: 9 Aug 2013 (actual)
First posted: 17 Jun 2013 (estimated)
Results: Posted 16 Jan 2015

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fluviral 18-60 Years Group	Experimental	Biological: Fluviral™Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluviral >60 Years Group	Experimental	Biological: Fluviral™Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female 18 years of age and older at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well-controlled chronic disease, as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.

Key exclusion criteria (28 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab etc.) within 6 months before study start, or planned administration during the study period.
Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period.

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
Fluviral™1 dose administered intramuscularly in deltoid region of non-dominant arm.	Biological	Fluviral 18-60 Years Group, Fluviral >60 Years Group

Primary outcome

Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains
Time frame: At Days 0 and 21
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 21
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 21
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Days 0 and Day 21
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

8 secondary outcomes

Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains
Time frame: At Days 0 and Day 21
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 21
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 21
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 0 and Day 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Time frame: During the 21-day (Days 0-20) post-vaccination period
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time frame: During the entire study period (Days 0-20 post vaccination)

Results and safety

Results posted to the registry on 16 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluviral 18-60 Years Group	60	60
Fluviral >60 Years Group	60	60

Primary outcome: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains

Time frame: At Days 0 and 21. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Fluviral 18-60 Years Group n = 59	Fluviral >60 Years Group n = 60
H1N1, Day 0	61.0 (41.2 to 90.5)	65.7 (48.6 to 88.9)
H1N1, Day 21	337.4 (260.9 to 436.3)	207.5 (163.3 to 263.5)
H3N2, Day 0	37.3 (26.9 to 51.6)	31.5 (23.3 to 42.7)
H3N2, Day 21	159.0 (124.1 to 203.8)	133.7 (101.5 to 176.2)
Yamagata, Day 0	200.0 (150.3 to 266.1)	159.0 (118.0 to 214.3)
Yamagata, Day 21	521.1 (417.9 to 649.8)	407.8 (328.9 to 505.7)

Population analysed: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Primary outcome: Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

Time frame: At Day 21. Number. Unit: Subjects

Measure	Fluviral 18-60 Years Group n = 59	Fluviral >60 Years Group n = 60
H1N1	32	22
H3N2	24	25
Yamagata	21	17

Primary outcome: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.

Time frame: At Day 21. Geometric mean (95% Confidence Interval). Unit: Fold increase

Measure	Fluviral 18-60 Years Group n = 59	Fluviral >60 Years Group n = 60
H1N1	5.5 (3.5 to 8.6)	3.2 (2.2 to 4.4)
H3N2	4.3 (3.0 to 6.1)	4.2 (3.0 to 6.0)
Yamagata	2.6 (1.9 to 3.5)	2.6 (1.9 to 3.5)

Primary outcome: Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

Time frame: At Days 0 and Day 21. Number. Unit: Subjects

Measure	Fluviral 18-60 Years Group n = 59	Fluviral >60 Years Group n = 60
H1N1, Day 0	41	44
H1N1, Day 21	59	59
H3N2, Day 0	37	33
H3N2, Day 21	56	54
Yamagata, Day 0	55	56
Yamagata, Day 21	59	60

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: From Day 0 to Day 20 post vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluarix/Influsplit 18-60 Years Group	0 of 60 (0%)	45 of 60 (75%)	Not reported
Fluarix/Influsplit > 60 Years Group	0 of 60 (0%)	23 of 60 (38.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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 3 study testing Fluviral™ in people with Influenza, run by GlaxoSmithKline at 1 site in Canada.

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 10 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 7 Sep 2018. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains (time frame: At 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 NCT01878825.

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 7 Sep 2018.