InfluenzaPhase 3NCT01878812

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older

A Phase 3 study testing Fluarix/Influsplit Tetra® (2013-2014 season) in people with Influenza, run by GlaxoSmithKline at 4 sites in Germany.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra containing the four influenza strains (two A strains and two B strains) for the 2013/2014 season. 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?: Fluarix/Influsplit Tetra® (2013-2014 season)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 4 sitesGermany
Study dates: 11 Jul 2013to 5 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 the investigator believes can and will comply with the requirements of the protocol.
A male or female aged 18 years or above at the time of vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering 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 vaccination.

Who cannot join

Participation in previous year's Fluarix registration study (116663).
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 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 the six months prior to vaccination. Inhaled and topical steroids are allowed.
Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
Administration of an influenza vaccine within the twelve months preceding the study vaccination.

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Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine during the entire study period.
Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
Acute disease and/or fever at the time of enrollment.
Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or clinically serious.
History of chronic alcohol consumption and/or drug abuse.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of Guillain-Barré syndrome.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex.
Anaphylaxis following the administration of vaccine(s).
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular injection unsafe.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

GSK Investigational Site
Dresden, Saxony, 01097
GSK Investigational Site
Dresden, Saxony, 01099
GSK Investigational Site
Dresden, Saxony, 01129
GSK Investigational Site
Dresden, Saxony, 01309

Other trials in Germany

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine (GSK2321138A) Fluarix/Influsplit Tetra® (2013/2014 Season) in Adults 18 Years of Age and Older

Conditions: Influenza
Being tested: Fluarix/Influsplit Tetra® (2013-2014 season)
Keywords: Immunogenicity, Influenza, Adults, Safety, Elderly
Medical subject headings: Influenza, Human

What participants receive

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

Fluarix/Influsplit Tetra® (2013-2014 season)Biological
1 dose administered intramuscularly in the deltoid region of non-dominant arm

Study groups in NCT01878812
Study group	Role	What they receive
Fluarix/Influsplit Tetra® Adult Group	Experimental	Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix/Influsplit Tetra® (2013-2014 season)
Fluarix/Influsplit Tetra® Elderly Group	Experimental	Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix/Influsplit Tetra® (2013-2014 season)

What is being measured

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

Anti-HI Antibody Titers Against 4 Strains of Influenza Disease
The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).
Measured: At Days 0 and 21
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.
Measured: At Day 21
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.
Measured: At Day 21
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.
Measured: At Day 21
Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.
Measured: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

Secondary outcomes (10)

Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Number of Days of Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value.
Measured: During the entire study period (Days 0 to 21)
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Number of Days of Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. The number of days is expressed as a mean value.
Measured: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: At Days 0 and 21
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.
Measured: At Days 0 and 21
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.
Measured: At Day 21
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.
Measured: At Day 21
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.
Measured: At Day 21

Timeline

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

11 Jul 20135 Aug 2013

First posted17 Jun 2013 (estimated)
Study start11 Jul 2013
Primary completion5 Aug 2013
Study completion5 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: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01878812
Sponsor's protocol ID: 200188
Other IDs: 2013-001094-25
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' Quadrivalent Split Virion Influenza Vaccine (GSK2321138A) Fluarix/Influsplit Tetra® (2013/2014 Season) in Adults 18 Years of Age and Older
ClinicalTrials.gov ID: NCT01878812
Acronym / sponsor ID: 200188
Conditions: Influenza
Keywords: Immunogenicity, Influenza, Adults, Safety, Elderly
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 11 Jul 2013 (actual)
Primary completion: 5 Aug 2013 (actual)
Study completion: 5 Aug 2013 (actual)
First posted: 17 Jun 2013 (estimated)
Results: Posted 12 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
Fluarix/Influsplit Tetra® Adult Group	Experimental	Biological: Fluarix/Influsplit Tetra® (2013-2014 season)Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix/Influsplit Tetra® Elderly Group	Experimental	Biological: Fluarix/Influsplit Tetra® (2013-2014 season)Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, 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 the investigator believes can and will comply with the requirements of the protocol.
A male or female aged 18 years or above at the time of vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
Female subjects of non-childbearing potential may be enrolled in the study.

Key exclusion criteria (21 listed)

Participation in previous year's Fluarix registration study (116663).
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 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 the six months prior to vaccination. Inhaled and topical steroids are allowed.
Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration 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
Fluarix/Influsplit Tetra® (2013-2014 season)1 dose administered intramuscularly in the deltoid region of non-dominant arm	Biological	Fluarix/Influsplit Tetra® Adult Group, Fluarix/Influsplit Tetra® Elderly Group

Primary outcome

Anti-HI Antibody Titers Against 4 Strains of Influenza Disease
Time frame: At Days 0 and 21
The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
Time frame: At Day 21
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
Time frame: At Day 21
The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
Time frame: At Day 21
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.
Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
Time frame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.

10 secondary outcomes

Number of Subjects With Solicited Local Symptoms
Time frame: During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Number of Days of Solicited Local Symptoms
Time frame: During the entire study period (Days 0 to 21)
Number of Subjects With Solicited General Symptoms
Time frame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Number of Days of Solicited General Symptoms
Time frame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Time frame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs).
Time frame: At Days 0 and 21
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status
Time frame: At Days 0 and 21
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status
Time frame: At Day 21
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status
Time frame: At Day 21
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status
Time frame: At Day 21

Results and safety

Results posted to the registry on 12 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
Fluarix/Influsplit Tetra® Adult Group	60	60
Fluarix/Influsplit Tetra® Elderly Group	57	57

Primary outcome: Anti-HI Antibody Titers Against 4 Strains of Influenza Disease

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

Measure	Fluarix/Influsplit Tetra® Adult Group n = 60	Fluarix/Influsplit Tetra® Elderly Group n = 56
Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56]	29.8 (20.7 to 42.8)	14.9 (10.9 to 20.4)
Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56]	13.1 (10.1 to 17.0)	13.5 (10.1 to 18.1)
Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56]	151.0 (111.3 to 204.7)	110.4 (88.5 to 137.6)
Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56]	58.5 (44.4 to 77.1)	56.6 (44.6 to 71.7)
Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56]	505.0 (400.1 to 637.4)	230.3 (160.7 to 330.2)
Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]	94.0 (74.1 to 119.3)	77.9 (58.5 to 103.9)
Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]	792.6 (661.6 to 949.5)	535.0 (442.2 to 647.2)
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]	346.9 (288.0 to 417.9)	239.2 (193.3 to 296.0)

Population analysed: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

Primary outcome: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

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

Measure	Fluarix/Influsplit Tetra® Adult Group n = 60	Fluarix/Influsplit Tetra® Elderly Group n = 56
Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56]	29	12
Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56]	60	49
Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56]	12	15
Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]	54	40
Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56]	56	52
Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]	60	56
Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56]	43	40
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]	60	55

Population analysed: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

Primary outcome: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease

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

Measure	Fluarix/Influsplit Tetra® Adult Group n = 60	Fluarix/Influsplit Tetra® Elderly Group n = 56
Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56]	48	43
Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]	41	27
Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]	35	32
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]	37	24

Population analysed: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

Primary outcome: Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease

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

Measure	Fluarix/Influsplit Tetra® Adult Group n = 60	Fluarix/Influsplit Tetra® Elderly Group n = 56
Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56]	17.0 (11.6 to 24.8)	15.4 (10.5 to 22.6)
Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]	7.2 (5.5 to 9.3)	5.8 (4.3 to 7.8)
Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]	5.3 (3.8 to 7.2)	4.8 (3.9 to 6.1)
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]	5.9 (4.4 to 7.9)	4.2 (3.2 to 5.7)

Population analysed: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluarix/Influsplit Tetra® Adult Group	0 of 60 (0%)	46 of 60 (76.7%)	Not reported
Fluarix/Influsplit Tetra® Elderly Group	0 of 57 (0%)	24 of 57 (42.1%)	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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluarix/Influsplit Tetra® (2013-2014 season) in people with Influenza, run by GlaxoSmithKline at 4 sites in Germany.

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 21 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 4 sites in Germany. 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 12 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?

Anti-HI Antibody Titers Against 4 Strains of Influenza Disease (time frame: At Days 0 and 21). The study lists 5 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 NCT01878812.

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.