InfluenzaPhase 3NCT01884519

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

A Phase 3 study testing Fluarix/Influsplit SSW® (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 SSW 2013/2014, containing the three vaccine influenza strains (two A strains and one B strain) 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 SSW® (2013-2014 season)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 4 sitesGermany
Study dates: 1 Jul 2013to 2 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.

Show all 10Show fewer

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 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.

Show all 21Show fewer

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, 01307
GSK Investigational Site
Freiberg, Saxony, 09599
GSK Investigational Site
Freital, Saxony, 01705
GSK Investigational Site
Schmiedeberg, Saxony, 01762

Other trials in Germany

About this study

Official title: Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2013/2014 in People 18 Years of Age and Above

Conditions: Influenza
Being tested: Fluarix/Influsplit SSW® (2013-2014 season)
Keywords: Elderly, Influenza, Safety, Adults, Immunogenicity
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 SSW® (2013-2014 season)Biological
1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm

Study groups in NCT01884519
Study group	Role	What they receive
Fluarix/Influsplit 18-60 Years Group	Experimental	Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. Receives: Biological: Fluarix/Influsplit SSW® (2013-2014 season)
Fluarix/Influsplit > 60 Years Group	Experimental	Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. Receives: Biological: Fluarix/Influsplit SSW® (2013-2014 season)

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/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Measured: At Day 0 and Day 21
Number of Subjects Who Were Seroprotected for Anti-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/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Measured: At Day 0 and Day 21
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 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/Christchurch/16/2010 (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/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Measured: At Day 21
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Measured: At Day 21

Secondary outcomes (10)

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/Christchurch/16/2010 (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 2 influenza seasons prior to season 2012/2013.
Measured: At Days 0 and 21
Number of Subjects Who Were Seroprotected for Anti-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/Christchurch/16/2010 (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 2 influenza seasons prior to season 2012/2013.
Measured: At Day 0 and Day 21
Number of Seroconverted Subjects for Anti-HA 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 ≥ 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/Christchurch/16/2010 (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 2 influenza seasons prior to season 2012/2013.
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/Christchurch/16/2010 (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 2 influenza seasons prior to season 2012/2013.
Measured: At 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
Duration of Solicited Local Symptoms.
Duration was defined as number of days with any grade of local symptoms.
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 [axillary 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 = axillary temperature above 39.0°C
Measured: During the 4-day (Days 0-3) post-vaccination period
Duration of Solicited General Symptoms.
Duration was defined as number of days with any grade of general symptoms.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related 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. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Measured: During the 21-day (Days 0-20) post-vaccination period
Number of Subjects Reporting Any and Related 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 and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (Days 0-180)

Timeline

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

1 Jul 20132 Aug 2013

First posted24 Jun 2013 (estimated)
Study start1 Jul 2013
Primary completion2 Aug 2013
Study completion2 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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01884519
Sponsor's protocol ID: 200160
Other IDs: 2013-000855-42
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: Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2013/2014 in People 18 Years of Age and Above
ClinicalTrials.gov ID: NCT01884519
Acronym / sponsor ID: 200160
Conditions: Influenza
Keywords: Elderly, Influenza, Safety, Adults, Immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Jul 2013
Primary completion: 2 Aug 2013 (actual)
Study completion: 2 Aug 2013 (actual)
First posted: 24 Jun 2013 (estimated)
Results: Posted 1 Dec 2014

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 18-60 Years Group	Experimental	Biological: Fluarix/Influsplit SSW® (2013-2014 season)Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Fluarix/Influsplit > 60 Years Group	Experimental	Biological: Fluarix/Influsplit SSW® (2013-2014 season)Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid 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 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 SSW® (2013-2014 season)1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm	Biological	Fluarix/Influsplit 18-60 Years Group, Fluarix/Influsplit > 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 Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 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/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 21
A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 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/Christchurch/16/2010 (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/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
Time frame: At Day 21
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

10 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 21
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 0 and Day 21
Number of Seroconverted Subjects for Anti-HA 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 Reporting Any and Grade 3 Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Duration of 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
Duration of Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the 21-day (Days 0-20) post-vaccination period
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: During the entire study period (Days 0-180)

Results and safety

Results posted to the registry on 1 Dec 2014, 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 18-60 Years Group	60	60
Fluarix/Influsplit > 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 Day 0 and Day 21. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Fluarix/Influsplit 18-60 Years Group n = 60	Fluarix/Influsplit > 60 Years Group n = 60
H1N1, Day 0	27.3 (20.3 to 36.8)	15.7 (12.1 to 20.4)
H1N1, Day 21	444.6 (335.6 to 588.9)	197.0 (142.6 to 272.1)
H3N2, Day 0	15.8 (11.9 to 21.1)	14.2 (11.0 to 18.4)
H3N2, Day 21	73.8 (57.8 to 94.2)	80.0 (58.4 to 109.5)
Yamagata, Day 0	105.0 (83.6 to 131.8)	95.2 (77.5 to 116.9)
Yamagata, Day 21	424.6 (347.6 to 518.8)	327.5 (266.2 to 402.9)

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 Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.

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

Measure	Fluarix/Influsplit 18-60 Years Group n = 60	Fluarix/Influsplit > 60 Years Group n = 60
H1N1, Day 0	25	14
H1N1, Day 21	58	56
H3N2, Day 0	12	12
H3N2, Day 21	50	44
Yamagata, Day 0	53	55
Yamagata, Day 21	60	60

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

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

Measure	Fluarix/Influsplit 18-60 Years Group n = 60	Fluarix/Influsplit > 60 Years Group n = 60
H1N1	44	46
H3N2	31	29
Yamagata	30	23

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	Fluarix/Influsplit 18-60 Years Group n = 60	Fluarix/Influsplit > 60 Years Group n = 60
H1N1	16.3 (10.8 to 24.5)	12.6 (8.7 to 18.2)
H3N2	4.7 (3.4 to 6.4)	5.6 (4.0 to 7.9)
Yamagata	4.0 (3.1 to 5.3)	3.4 (2.7 to 4.3)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: From Day 0 to Day 180; 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%)	47 of 60 (78.3%)	Not reported
Fluarix/Influsplit > 60 Years Group	0 of 60 (0%)	24 of 60 (40%)	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 SSW® (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 1 Dec 2014). 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 Day 0 and Day 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 NCT01884519.

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.