InfluenzaPhase 3NCT00772889

Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

A Phase 3 study testing Influenza vaccine GSK2186877A and GSK Biologicals' Fluarix™ in people with Influenza, run by GlaxoSmithKline at 29 sites in 4 countries.

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 observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516). Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza vaccine GSK2186877A and GSK Biologicals' Fluarix™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 971 participants
Where: 29 sitesin 4 countries
Study dates: 9 Oct 2008to 15 Dec 2009
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 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study
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 2 months after completion of the vaccination series.

Who cannot join

Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Any vaccination against influenza since January 2008 with any seasonal influenza vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Show all 15Show fewer

History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccines.
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
Acute disease at the time of enrolment.
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.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
Any medical conditions in which intramuscular injections are contraindicated.
Pregnant or lactating females.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

29 sites in 4 countries.

Country

City, postcode or hospital

29 sites in 4 countries

Germany12 sites

GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Berlin, 10365
GSK Investigational Site
Berlin, 10367
GSK Investigational Site
Berlin, 12687
GSK Investigational Site
Berlin, 13086
GSK Investigational Site
Berlin, 13507
GSK Investigational Site
Haag, Bavaria, 83527
GSK Investigational Site
Höhenkirchen-Siegertsbrunn, Bavaria, 85635
GSK Investigational Site
Langquaid, Bavaria, 84085
GSK Investigational Site
Leipzig, Saxony, 04129
GSK Investigational Site
Messkirch, Baden-Wurttemberg, 88605
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562

Other trials in Germany

United States9 sites

GSK Investigational Site
Carnegie, Pennsylvania, 15106
GSK Investigational Site
Chaska, Minnesota, 55318
GSK Investigational Site
Clearwater, Florida, 33761
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Erie, Pennsylvania, 16506
GSK Investigational Site
Milford, Massachusetts, 01757
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Poughkeepsie, New York, 12601
GSK Investigational Site
Somers Point, New Jersey, 08244

Other trials in United States

Norway7 sites

GSK Investigational Site
Bekkestua, 1319
GSK Investigational Site
Bergen, 5094
GSK Investigational Site
Elverum, 2408
GSK Investigational Site
Fredrikstad, N-1601
GSK Investigational Site
Hamar, 2317
GSK Investigational Site
Haugesund, 5528
GSK Investigational Site
Skien, 3717

Other trials in Norway

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

Conditions: Influenza
Being tested: Influenza vaccine GSK2186877A, GSK Biologicals' Fluarix™
Keywords: Elderly, Vaccine, 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.

Influenza vaccine GSK2186877ABiological
One intramuscularly injection at Day 0
GSK Biologicals' Fluarix™Biological
One intramuscularly injection at Day 0

Study groups in NCT00772889
Study group	Role	What they receive
New generation influenza vaccine GSK2186877A Group	Experimental	Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A. Receives: Biological: Influenza vaccine GSK2186877A
Fluarix elderly Group	Active comparator	Subjects aged ≥66 years received one dose of Fluarix vaccine. Receives: Biological: GSK Biologicals' Fluarix™
Fluarix young Group	Active comparator	Subjects aged 19-43 years received one dose of Fluarix vaccine. Receives: Biological: GSK Biologicals' Fluarix™

What is being measured

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

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.
Measured: Day 0-6
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
Measured: Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.
Measured: Day 0-6
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Measured: Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited 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. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.
Measured: Day 0-20
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Measured: Day 0-20
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.
Measured: Day 0-20
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: Day 0-20

Secondary outcomes (8)

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Measured: Day 21-179
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Measured: Day 21-364.
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: Day 0-21
The Number of Subjects Seropositive to HI Antibodies
A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: Day 0-21
The Number of Subjects Seroprotected by HI Antibodies
A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: Day 0-21
The Number of Subjects Seroconverted to HI Antibodies
A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 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 included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: At Day 21
HI Antibody Seroconversion Factors (SCF)
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: At Day 21
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: Day 21-364

Timeline

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

9 Oct 200815 Dec 2009

First posted15 Oct 2008 (estimated)
Study start9 Oct 2008
Primary completion15 Dec 2009
Study completion15 Dec 2009

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 971 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772889
Sponsor's protocol ID: 111738
Status last verified: Apr 2017
First submitted: 10 Oct 2008
Last updated: 31 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this 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 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly
ClinicalTrials.gov ID: NCT00772889
Acronym / sponsor ID: 111738
Conditions: Influenza
Keywords: Elderly, Vaccine, Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 971 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Oct 2008
Primary completion: 15 Dec 2009 (actual)
Study completion: 15 Dec 2009 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 24 Apr 2012

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
New generation influenza vaccine GSK2186877A Group	Experimental	Biological: Influenza vaccine GSK2186877ASubjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
Fluarix elderly Group	Active comparator	Biological: GSK Biologicals' Fluarix™Subjects aged ≥66 years received one dose of Fluarix vaccine.
Fluarix young Group	Active comparator	Biological: GSK Biologicals' Fluarix™Subjects aged 19-43 years received one dose of Fluarix vaccine.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study
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 2 months after completion of the vaccination series.

Key exclusion criteria (15 listed)

Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Any vaccination against influenza since January 2008 with any seasonal influenza vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

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
Influenza vaccine GSK2186877AOne intramuscularly injection at Day 0	Biological	New generation influenza vaccine GSK2186877A Group
GSK Biologicals' Fluarix™One intramuscularly injection at Day 0	Biological	Fluarix elderly Group, Fluarix young Group

Primary outcome

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: Day 0-6
Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.
Duration of Solicited Local AEs
Time frame: Day 0-6
Duration was defined as number of days with any grade of local symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: Day 0-6
Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General AEs
Time frame: Day 0-6
Duration was defined as number of days with any grade of general symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Time frame: Day 0-20
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. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20
Time frame: Day 0-20
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20
Time frame: Day 0-20
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20
Time frame: Day 0-20
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.

8 secondary outcomes

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179
Time frame: Day 21-179
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364
Time frame: Day 21-364.
Haemagglutination Inhibition (HI) Antibody Titers
Time frame: Day 0-21
The Number of Subjects Seropositive to HI Antibodies
Time frame: Day 0-21
The Number of Subjects Seroprotected by HI Antibodies
Time frame: Day 0-21
The Number of Subjects Seroconverted to HI Antibodies
Time frame: At Day 21
HI Antibody Seroconversion Factors (SCF)
Time frame: At Day 21
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364
Time frame: Day 21-364

Results and safety

Results posted to the registry on 24 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Generation Influenza Vaccine GSK2186877A Group	375	353
Fluarix Elderly Group	393	375
Fluarix Young Group	203	187

Primary outcome: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

Time frame: Day 0-6. Count of participants. Unit: Participants

Measure	New Generation Influenza Vaccine GSK2186877A Group n = 375	Fluarix Elderly Group n = 392	Fluarix Young Group n = 203
Any ecchymosis	2	3	1
Grade 3 ecchymosis	0	0	0
Any pain	159	49	122
Grade 3 pain	0	0	0
Any redness	57	10	9
Grade 3 redness	3	0	0
Any swelling	23	6	7
Grade 3 swelling	0	0	0

Population analysed: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Primary outcome: Duration of Solicited Local AEs

Time frame: Day 0-6. Median (Full Range). Unit: Days

Measure	New Generation Influenza Vaccine GSK2186877A Group n = 159	Fluarix Elderly Group n = 49	Fluarix Young Group n = 122
Ecchymosis	6.5 (6.0 to 7.0)	5.0 (3.0 to 5.0)	2.0 (2.0 to 2.0)
Pain	2.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)	2.0 (1.0 to 5.0)
Redness	3.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)	1.0 (1.0 to 6.0)
Swelling	2.0 (1.0 to 7.0)	1.5 (1.0 to 5.0)	1.0 (1.0 to 3.0)

Population analysed: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.

Primary outcome: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

Time frame: Day 0-6. Count of participants. Unit: Participants

Measure	New Generation Influenza Vaccine GSK2186877A Group n = 375	Fluarix Elderly Group n = 392	Fluarix Young Group n = 203
Any arthralgia	44	20	11
Grade 3 arthralgia	0	0	1
Related arthralgia	25	8	9
Any fatigue	72	37	39
Grade 3 fatigue	1	2	2
Related fatigue	40	17	28
Any gastrointestinal symptoms	26	18	9
Grade 3 gastrointestinal symptoms	1	1	0

Population analysed: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Primary outcome: Duration of Solicited General AEs

Time frame: Day 0-6. Median (Full Range). Unit: Days

Measure	New Generation Influenza Vaccine GSK2186877A Group n = 72	Fluarix Elderly Group n = 38	Fluarix Young Group n = 39
Arthralgia	2.0 (1.0 to 7.0)	3.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)
Fatigue	2.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)
Gastrointestinal symptoms	2.0 (1.0 to 5.0)	2.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)
Headache	1.0 (1.0 to 6.0)	2.0 (1.0 to 7.0)	1.0 (1.0 to 5.0)
Myalgia	2.0 (1.0 to 7.0)	3.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)
Shivering	1.0 (1.0 to 7.0)	1.5 (1.0 to 5.0)	2.0 (1.0 to 5.0)
Fever	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	3.0 (3.0 to 3.0)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Generation Influenza Vaccine GSK2186877A Group	40 of 375 (10.7%)	218 of 375 (58.1%)	Not reported
Fluarix Elderly Group	43 of 393 (10.9%)	109 of 393 (27.7%)	Not reported
Fluarix Young Group	4 of 203 (2%)	133 of 203 (65.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this 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

29 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza vaccine GSK2186877A and GSK Biologicals' Fluarix™ in people with Influenza, run by GlaxoSmithKline at 29 sites in 4 countries.

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 15 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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany, United States, Norway, 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 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 24 Apr 2012). 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?

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) (time frame: Day 0-6). The study lists 8 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 NCT00772889.

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 31 Jul 2018.