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NCT00772889

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

Completed Phase 3 Results posted Last updated 31 July 2018
What this trial tests

Phase 3 trial testing Influenza vaccine GSK2186877A in Influenza in 971 participants. Completed in 15 December 2009.

Timeline
9 October 2008
Primary endpoint
15 December 2009
15 December 2009

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment971
Start date9 October 2008
Primary completion15 December 2009
Estimated completion15 December 2009
Sites29 locations across Belgium, United States, Germany, Norway

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

19 and older, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Any ecchymosis
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2
Fluarix Elderly Group3
Fluarix Young Group1
Grade 3 ecchymosis
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Any pain
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group159
Fluarix Elderly Group49
Fluarix Young Group122
Grade 3 pain
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Any redness
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group57
Fluarix Elderly Group10
Fluarix Young Group9
Grade 3 redness
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group3
Fluarix Elderly Group0
Fluarix Young Group0
Any swelling
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group23
Fluarix Elderly Group6
Fluarix Young Group7
Grade 3 swelling
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Duration of Solicited Local AEs Primary · Day 0-6

Duration was defined as number of days with any grade of local symptoms.

Ecchymosis
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group6.56.0 – 7.0
Fluarix Elderly Group5.03.0 – 5.0
Fluarix Young Group2.02.0 – 2.0
Pain
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group2.01.0 – 7.0
Fluarix Young Group2.01.0 – 5.0
Redness
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group3.01.0 – 7.0
Fluarix Elderly Group2.01.0 – 7.0
Fluarix Young Group1.01.0 – 6.0
Swelling
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group1.51.0 – 5.0
Fluarix Young Group1.01.0 – 3.0
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Primary · 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.

Any arthralgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group44
Fluarix Elderly Group20
Fluarix Young Group11
Grade 3 arthralgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group1
Related arthralgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group25
Fluarix Elderly Group8
Fluarix Young Group9
Any fatigue
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group72
Fluarix Elderly Group37
Fluarix Young Group39
Grade 3 fatigue
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1
Fluarix Elderly Group2
Fluarix Young Group2
Related fatigue
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group40
Fluarix Elderly Group17
Fluarix Young Group28
Any gastrointestinal symptoms
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group26
Fluarix Elderly Group18
Fluarix Young Group9
Grade 3 gastrointestinal symptoms
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1
Fluarix Elderly Group1
Fluarix Young Group0
Duration of Solicited General AEs Primary · Day 0-6

Duration was defined as number of days with any grade of general symptoms.

Arthralgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group3.01.0 – 7.0
Fluarix Young Group2.01.0 – 7.0
Fatigue
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group2.01.0 – 7.0
Fluarix Young Group2.01.0 – 7.0
Gastrointestinal symptoms
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 5.0
Fluarix Elderly Group2.01.0 – 7.0
Fluarix Young Group2.01.0 – 7.0
Headache
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1.01.0 – 6.0
Fluarix Elderly Group2.01.0 – 7.0
Fluarix Young Group1.01.0 – 5.0
Myalgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group3.01.0 – 7.0
Fluarix Young Group2.01.0 – 7.0
Shivering
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1.01.0 – 7.0
Fluarix Elderly Group1.51.0 – 5.0
Fluarix Young Group2.01.0 – 5.0
Fever
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1.01.0 – 1.0
Fluarix Elderly Group1.01.0 – 1.0
Fluarix Young Group3.03.0 – 3.0
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Primary · 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.

Any AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group45
Fluarix Elderly Group47
Fluarix Young Group38
Grade 3 AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group3
Fluarix Elderly Group8
Fluarix Young Group1
Related AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group8
Fluarix Elderly Group5
Fluarix Young Group3
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 Primary · 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.

Any MAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group17
Fluarix Elderly Group22
Fluarix Young Group9
Grade 3 MAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group3
Fluarix Elderly Group6
Fluarix Young Group1
Related MAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group1
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20 Primary · 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.

GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 Primary · 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.

Any SAEs
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group3
Fluarix Elderly Group4
Fluarix Young Group0
Related SAEs
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 Secondary · 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 a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.

Any MAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group89
Fluarix Elderly Group111
Fluarix Young Group55
Grade 3 MAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group22
Fluarix Elderly Group26
Fluarix Young Group14
Related MAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 Secondary · Day 21-364.

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.

Any AESI
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2
Fluarix Elderly Group0
Fluarix Young Group0
Grade 3 AESI
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Related AESI
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Haemagglutination Inhibition (HI) Antibody Titers Secondary · Day 0-21

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.

A/Brisbane strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group28.525.7 – 31.5
Fluarix Elderly Group22.920.7 – 25.3
Fluarix Young Group52.844.6 – 62.5
A/Brisbane strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group70.864.7 – 77.4
Fluarix Elderly Group51.947.0 – 57.2
Fluarix Young Group112.598.4 – 128.5
A/Uruguay strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group48.943.5 – 54.8
Fluarix Elderly Group29.225.7 – 33.1
Fluarix Young Group29.225.1 – 34.0
A/Uruguay strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group331.3296.7 – 370.0
Fluarix Elderly Group149.2131.1 – 169.9
Fluarix Young Group161.7137.8 – 189.8
B/Brisbane strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group169.1153.2 – 186.7
Fluarix Elderly Group157.4143.2 – 173.1
Fluarix Young Group196.4167.3 – 230.5
B/Brisbane strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group576.5526.5 – 631.1
Fluarix Elderly Group463.5422.0 – 509.1
Fluarix Young Group765.2682.3 – 858.1
The Number of Subjects Seropositive to HI Antibodies Secondary · Day 0-21

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.

A/Brisbane strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group336
Fluarix Elderly Group315
Fluarix Young Group186
A/Brisbane strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group364
Fluarix Elderly Group366
Fluarix Young Group193
A/Uruguay strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group344
Fluarix Elderly Group320
Fluarix Young Group167
A/Uruguay strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group368
Fluarix Elderly Group368
Fluarix Young Group191
B/Brisbane strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group366
Fluarix Elderly Group374
Fluarix Young Group192
B/Brisbane strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group368
Fluarix Elderly Group375
Fluarix Young Group194

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

New Generation Influenza Vaccine GSK2186877A Group
Serious: 40/375 (11%)
Deaths: —
Fluarix Elderly Group
Serious: 43/393 (11%)
Deaths: —
Fluarix Young Group
Serious: 4/203 (2%)
Deaths: —

Serious adverse events (92 terms)

ReactionSystemNew Generation Influenza V…Fluarix Elderly GroupFluarix Young Group
Hip fractureInjury, poisoning and procedural complications———
Myocardial infarctionCardiac disorders———
PneumoniaInfections and infestations———
Gastrointestinal haemorrhageGastrointestinal disorders———
Atrial fibrillationCardiac disorders———
Humerus fractureInjury, poisoning and procedural complications———
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders———
Chest painGeneral disorders———
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
AppendicitisInfections and infestations———
Tendon ruptureInjury, poisoning and procedural complications———
Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders———
Small intestinal obstructionGastrointestinal disorders———
Peripheral arterial occlusive diseaseVascular disorders———
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
Cerebral infarctionNervous system disorders———
UrosepsisInfections and infestations———
DiarrhoeaGastrointestinal disorders———
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
PyelonephritisInfections and infestations———
UrosepsisInfections and infestations———
Coronary artery occlusionCardiac disorders———
Pneumonia bacterialInfections and infestations———
SclerodermaMusculoskeletal and connective tissue disorders———
Other adverse events (9 terms — click to expand)

ReactionSystemNew Generation Influenza V…Fluarix Elderly GroupFluarix Young Group
PainGeneral disorders———
FatigueGeneral disorders———
MyalgiaGeneral disorders———
RednessGeneral disorders———
HeadacheGeneral disorders———
ArthralgiaGeneral disorders———
ShiveringGeneral disorders———
Gastrointestinal symptomsGeneral disorders———
SwellingGeneral disorders———

Most-reported serious reactions: Hip fracture, Myocardial infarction, Pneumonia, Gastrointestinal haemorrhage, Atrial fibrillation, Humerus fracture, Chronic obstructive pulmonary disease, Chest pain.

Data from ClinicalTrials.gov NCT00772889 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing