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NCT00760617

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

Completed Phase 3 Results posted Last updated 17 August 2018
What this trial tests

Phase 3 trial testing GSK Bio's influenza vaccine GSK2186877A in Influenza in 526 participants. Completed in 15 May 2009.

Timeline
6 October 2008
Primary endpoint
15 May 2009
15 May 2009

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment526
Start date6 October 2008
Primary completion15 May 2009
Estimated completion15 May 2009
Sites25 locations across Sweden, Netherlands, Germany

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 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 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.

Any ecchymosis
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2
Fluarix Elderly Group2
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 Group108
Fluarix Elderly Group18
Fluarix Young Group61
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 Group43
Fluarix Elderly Group5
Fluarix Young Group3
Grade 3 redness
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1
Fluarix Elderly Group0
Fluarix Young Group0
Any swelling
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group20
Fluarix Elderly Group7
Fluarix Young Group1
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 and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (\>) 20mm.

Ecchymosis
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group6.06.0 – 6.0
Fluarix Elderly Group4.02.0 – 6.0
Fluarix Young Group7.07.0 – 7.0
Pain
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group2.01.0 – 6.0
Fluarix Young Group2.01.0 – 7.0
Redness
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group2.02.0 – 3.0
Fluarix Young Group2.01.0 – 2.0
Swelling
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group3.01.0 – 5.0
Fluarix Young Group2.02.0 – 2.0
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 \>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.

Any arthralgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group30
Fluarix Elderly Group6
Fluarix Young Group10
Grade 3 arthralgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Related arthralgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group20
Fluarix Elderly Group5
Fluarix Young Group7
Any fatigue
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group51
Fluarix Elderly Group11
Fluarix Young Group27
Grade 3 fatigue
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1
Fluarix Elderly Group0
Fluarix Young Group2
Related fatigue
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group39
Fluarix Elderly Group10
Fluarix Young Group19
Any gastrointestinal symptoms
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group24
Fluarix Elderly Group5
Fluarix Young Group9
Grade 3 gastrointestinal symptoms
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group2
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 – 5.0
Fluarix Elderly Group1.51.0 – 3.0
Fluarix Young Group3.01.0 – 5.0
Fatigue
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 7.0
Fluarix Elderly Group2.01.0 – 5.0
Fluarix Young Group2.01.0 – 5.0
Gastrointestinal symptoms
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1.01.0 – 7.0
Fluarix Elderly Group2.01.0 – 6.0
Fluarix Young Group1.01.0 – 3.0
Headache
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1.01.0 – 7.0
Fluarix Elderly Group1.01.0 – 3.0
Fluarix Young Group1.51.0 – 4.0
Myalgia
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group2.01.0 – 4.0
Fluarix Elderly Group2.02.0 – 5.0
Fluarix Young Group2.01.0 – 6.0
Shivering
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1.01.0 – 6.0
Fluarix Elderly Group2.01.0 – 2.0
Fluarix Young Group1.01.0 – 2.0
Fever
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1.01.0 – 7.0
Fluarix Elderly Group1.01.0 – 1.0
Fluarix Young Group1.01.0 – 1.0
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Primary · 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.

Any AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group49
Fluarix Elderly Group20
Fluarix Young Group18
Grade 3 AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group6
Fluarix Elderly Group1
Fluarix Young Group4
Related AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group1
Fluarix Elderly Group2
Fluarix Young Group0
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.

Any AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group20
Fluarix Elderly Group8
Fluarix Young Group9
Grade 3 AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group4
Fluarix Elderly Group1
Fluarix Young Group1
Related AE(s)
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 Between Day 21 to 179 Primary · 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.

Any AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group103
Fluarix Elderly Group48
Fluarix Young Group33
Grade 3 AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group26
Fluarix Elderly Group8
Fluarix Young Group9
Related AE(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 Disease (AID) Primary · 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.

Any AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Grade 3 AE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Related AE(s)
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) Between 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 event assessed by the investigator as causally related to the study vaccination.

Any SAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group4
Fluarix Elderly Group2
Fluarix Young Group1
Related SAE(s)
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) Between Day 21 to Day 179 Primary · 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.

Any SAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group19
Fluarix Elderly Group7
Fluarix Young Group2
Related SAE(s)
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 180 to Day 209 Primary · 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.

Any SAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group3
Fluarix Young Group0
Related SAE(s)
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group0
Fluarix Elderly Group0
Fluarix Young Group0
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 Secondary · At Day 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.

A/Brisbane vaccine strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group27.924.7 – 31.6
Fluarix Elderly Group22.919.6 – 26.7
Fluarix Young Group43.233.9 – 54.9
A/Brisbane vaccine strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group74.666.7 – 83.3
Fluarix Elderly Group57.549.5 – 66.8
Fluarix Young Group164.7133.9 – 202.5
A/Uruguay vaccine strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group28.124.3 – 32.6
Fluarix Elderly Group22.819.0 – 27.4
Fluarix Young Group28.922.9 – 36.5
A/Uruguay vaccine strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group243.9213.5 – 278.7
Fluarix Elderly Group134.8107.9 – 168.4
Fluarix Young Group171.1141.0 – 207.7
B/Brisbane vaccine strain at Day 0
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group126.5111.5 – 143.5
Fluarix Elderly Group159.9136.1 – 188.0
Fluarix Young Group192.7150.6 – 246.7
B/Brisbane vaccine strain at Day 21
GroupValue95% CI
New Generation Influenza Vaccine GSK2186877A Group519.0467.1 – 576.6
Fluarix Elderly Group402.5344.2 – 470.6
Fluarix Young Group711.5611.2 – 828.2

Adverse events — posted to ClinicalTrials.gov

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.. 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: 19/266 (7%)
Deaths: —
Fluarix Elderly Group
Serious: 7/144 (5%)
Deaths: —
Fluarix Young Group
Serious: 2/116 (2%)
Deaths: —

Serious adverse events (48 terms)

ReactionSystemNew Generation Influenza V…Fluarix Elderly GroupFluarix Young Group
Cerebrovascular accidentNervous system disorders———
OsteoarthritisMusculoskeletal and connective tissue disorders———
Angina pectorisCardiac disorders———
PneumoniaInfections and infestations———
Cardiac failureCardiac disorders———
Central nervous system lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
ConcussionInjury, poisoning and procedural complications———
Facial bones fractureInjury, poisoning and procedural complications———
Locked-in syndromeNervous system disorders———
OsteoarthritisMusculoskeletal and connective tissue disorders———
PneumoniaInfections and infestations———
Postoperative wound infectionInfections and infestations———
Renal failure acuteRenal and urinary disorders———
Skin lacerationInjury, poisoning and procedural complications———
Testicular torsionReproductive system and breast disorders———
Transient ischaemic attackNervous system disorders———
Myocardial infarctionCardiac disorders———
Abortion spontaneousPregnancy, puerperium and perinatal conditions———
Anoxic encephalopathyNervous system disorders———
ArrhythmiaCardiac disorders———
Atrial fibrillationCardiac disorders———
Atrioventricular blockCardiac disorders———
Back painMusculoskeletal and connective tissue disorders———
Cardiac failureCardiac disorders———
Cartilage injuryInjury, poisoning and procedural complications———
Other adverse events (10 terms — click to expand)

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

Most-reported serious reactions: Cerebrovascular accident, Osteoarthritis, Angina pectoris, Pneumonia, Cardiac failure, Central nervous system lymphoma, Concussion, Facial bones fracture.

Data from ClinicalTrials.gov NCT00760617 adverse events section.

Sponsor's own description

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).

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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