InfluenzaPhase 3NCT00760617

Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older

A Phase 3 study testing GSK Bio's influenza vaccine GSK2186877A and Fluarix in people with Influenza, run by GlaxoSmithKline at 25 sites in 3 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 study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. This protocol posting deals with objectives \& outcome measures of the extension phase at year 1. 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?: GSK Bio's influenza vaccine GSK2186877A and Fluarix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 526 participants
Where: 25 sitesin 3 countries
Study dates: 6 Oct 2008to 15 May 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
Written informed consent obtained from the subject.
Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Female subjects must be of non-childbearing potential.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
Vaccination against influenza since January 2008 with a seasonal influenza vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of hypersensivity to a previous dose of influenza vaccine.

Show all 12Show fewer

History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed 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 first administration of the study vaccine or planned administration during the study.
Any medical conditions in which IM injections are contraindicated.
Lactating female, female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

25 sites in 3 countries.

Country

City, postcode or hospital

25 sites in 3 countries

Germany20 sites

GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Berlin, 10435
GSK Investigational Site
Berlin, 12627
GSK Investigational Site
Berlin, 13347
GSK Investigational Site
Berlin, 13359
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Dresden, Saxony, 01067
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Freital, Saxony, 01705
GSK Investigational Site
Güglingen, Baden-Wurttemberg, 74363
GSK Investigational Site
Hamburg, 22335
GSK Investigational Site
Hamburg, 22415
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624
GSK Investigational Site
Rudersberg, Baden-Wurttemberg, 73635
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Wolmirstedt, Saxony-Anhalt, 39326

Other trials in Germany

Sweden3 sites

GSK Investigational Site
Eskilstuna, SE-631 88
GSK Investigational Site
Karlskrona, SE-371 41
GSK Investigational Site
Uppsala, SE-751 85

Other trials in Sweden

Netherlands2 sites

GSK Investigational Site
Rotterdam, 3001 DC
GSK Investigational Site
Rotterdam, 3011 EN

Other trials in Netherlands

About this study

Official title: Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects.

The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 1. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).

Conditions: Influenza
Being tested: GSK Bio's influenza vaccine GSK2186877A, Fluarix
Keywords: Influenza, 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.

GSK Bio's influenza vaccine GSK2186877ABiological
Intramuscular (IM) administration, 1 dose
FluarixBiological
Intramuscular (IM) administration, 1 dose

Study groups in NCT00760617
Study group	Role	What they receive
New generation influenza vaccine GSK2186877A Group	Experimental	Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A Receives: Biological: GSK Bio's influenza vaccine GSK2186877A
Fluarix elderly Group	Active comparator	Subjects aged ≥65 years received 1 dose of Fluarix vaccine Receives: Biological: Fluarix
Fluarix young Group	Active comparator	Subjects aged 18-40 years received 1 dose of Fluarix vaccine Receives: Biological: 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 was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Measured: Day 0-6
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.
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 >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Measured: Day 0-6
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 adverse event (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 unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.
Measured: Day 0-20
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Measured: Day 0-20
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Measured: Day 21-179
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)
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 autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Measured: Day 0-179
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between 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 event assessed by the investigator as causally related to the study vaccination.
Measured: Day 0-20
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179
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 event assessed by the investigator as causally related to the study vaccination.
Measured: Day 21-179
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209
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 event assessed by the investigator as causally related to the study vaccination.
Measured: Day 180 to Day 209

Secondary outcomes (11)

Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: At Day 0 and 21
HI Antibody Titers at Day 180
Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: Day 180
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21
Seropositivity was defined as 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: At Day 0 and 21
The Number of Subjects Seropositive to HI Antibodies at Day 180
Seropositivity was defined as 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 180
The Number of Subjects Seroconverted to HI Antibodies at Day 21
Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: Day 21
The Number of Subjects Seroconverted to HI Antibodies at Day 180
Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: Day 180
HI Antibody Seroconversion Factor (SCF) at Day 21
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: Day 21
HI Antibody SCF at Day 180
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: Day 180
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21
Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: At Day 0 and 21
The Number of Subjects Seroprotected to HI Antibodies at Day 180
Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: Day 180
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21
The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Measured: At Day 0 and 21

Timeline

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

6 Oct 200815 May 2009

First posted26 Sep 2008 (estimated)
Study start6 Oct 2008
Primary completion15 May 2009
Study completion15 May 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 526 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00760617
Sponsor's protocol ID: 111737
Status last verified: Oct 2016
First submitted: 25 Sep 2008
Last updated: 17 Aug 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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects.
ClinicalTrials.gov ID: NCT00760617
Acronym / sponsor ID: 111737
Conditions: Influenza
Keywords: Influenza, Elderly
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 526 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 6 Oct 2008
Primary completion: 15 May 2009 (actual)
Study completion: 15 May 2009 (actual)
First posted: 26 Sep 2008 (estimated)
Results: Posted 23 Apr 2012

Clinical summary

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

The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
New generation influenza vaccine GSK2186877A Group	Experimental	Biological: GSK Bio's influenza vaccine GSK2186877ASubjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
Fluarix elderly Group	Active comparator	Biological: FluarixSubjects aged ≥65 years received 1 dose of Fluarix vaccine
Fluarix young Group	Active comparator	Biological: FluarixSubjects aged 18-40 years received 1 dose of Fluarix vaccine

Who may qualify

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

Key inclusion criteria (5 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
Written informed consent obtained from the subject.
Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Female subjects must be of non-childbearing potential.

Key exclusion criteria (12 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
Vaccination against influenza since January 2008 with a seasonal influenza vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

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
GSK Bio's influenza vaccine GSK2186877AIntramuscular (IM) administration, 1 dose	Biological	New generation influenza vaccine GSK2186877A Group
FluarixIntramuscular (IM) administration, 1 dose	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 was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Duration of Solicited Local AEs
Time frame: Day 0-6
Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.
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 >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom 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 adverse event (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 unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179
Time frame: Day 21-179
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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)
Time frame: Day 0-179
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 autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between 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 event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179
Time frame: Day 21-179
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 event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209
Time frame: Day 180 to Day 209
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 event assessed by the investigator as causally related to the study vaccination.

11 secondary outcomes

Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Time frame: At Day 0 and 21
HI Antibody Titers at Day 180
Time frame: Day 180
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21
Time frame: At Day 0 and 21
The Number of Subjects Seropositive to HI Antibodies at Day 180
Time frame: Day 180
The Number of Subjects Seroconverted to HI Antibodies at Day 21
Time frame: Day 21
The Number of Subjects Seroconverted to HI Antibodies at Day 180
Time frame: Day 180
HI Antibody Seroconversion Factor (SCF) at Day 21
Time frame: Day 21
HI Antibody SCF at Day 180
Time frame: Day 180
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21
Time frame: At Day 0 and 21
The Number of Subjects Seroprotected to HI Antibodies at Day 180
Time frame: Day 180
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21
Time frame: At Day 0 and 21

Results and safety

Results posted to the registry on 23 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	266	261
Fluarix Elderly Group	144	142
Fluarix Young Group	116	111

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 = 265	Fluarix Elderly Group n = 144	Fluarix Young Group n = 115
Any ecchymosis	2	2	1
Grade 3 ecchymosis	0	0	0
Any pain	108	18	61
Grade 3 pain	0	0	0
Any redness	43	5	3
Grade 3 redness	1	0	0
Any swelling	20	7	1
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 = 108	Fluarix Elderly Group n = 18	Fluarix Young Group n = 61
Ecchymosis	6.0 (6.0 to 6.0)	4.0 (2.0 to 6.0)	7.0 (7.0 to 7.0)
Pain	2.0 (1.0 to 7.0)	2.0 (1.0 to 6.0)	2.0 (1.0 to 7.0)
Redness	2.0 (1.0 to 7.0)	2.0 (2.0 to 3.0)	2.0 (1.0 to 2.0)
Swelling	2.0 (1.0 to 7.0)	3.0 (1.0 to 5.0)	2.0 (2.0 to 2.0)

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 = 265	Fluarix Elderly Group n = 144	Fluarix Young Group n = 115
Any arthralgia	30	6	10
Grade 3 arthralgia	0	0	0
Related arthralgia	20	5	7
Any fatigue	51	11	27
Grade 3 fatigue	1	0	2
Related fatigue	39	10	19
Any gastrointestinal symptoms	24	5	9
Grade 3 gastrointestinal symptoms	0	0	2

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 = 51	Fluarix Elderly Group n = 11	Fluarix Young Group n = 30
Arthralgia	2.0 (1.0 to 5.0)	1.5 (1.0 to 3.0)	3.0 (1.0 to 5.0)
Fatigue	2.0 (1.0 to 7.0)	2.0 (1.0 to 5.0)	2.0 (1.0 to 5.0)
Gastrointestinal symptoms	1.0 (1.0 to 7.0)	2.0 (1.0 to 6.0)	1.0 (1.0 to 3.0)
Headache	1.0 (1.0 to 7.0)	1.0 (1.0 to 3.0)	1.5 (1.0 to 4.0)
Myalgia	2.0 (1.0 to 4.0)	2.0 (2.0 to 5.0)	2.0 (1.0 to 6.0)
Shivering	1.0 (1.0 to 6.0)	2.0 (1.0 to 2.0)	1.0 (1.0 to 2.0)
Fever	1.0 (1.0 to 7.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 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	19 of 266 (7.1%)	160 of 266 (60.2%)	Not reported
Fluarix Elderly Group	7 of 144 (4.9%)	39 of 144 (27.1%)	Not reported
Fluarix Young Group	2 of 116 (1.7%)	80 of 116 (69%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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

25 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK Bio's influenza vaccine GSK2186877A and Fluarix in people with Influenza, run by GlaxoSmithKline at 25 sites in 3 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 12 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Germany, Sweden, Netherlands. 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 23 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 11 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 NCT00760617.

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 17 Aug 2018.