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

GlaxoSmithKline526 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

526

Conditions

Influenza

Interventions

GSK Bio's influenza vaccine GSK2186877ABIOLOGICAL

Intramuscular (IM) administration, 1 dose

FluarixBIOLOGICAL

Intramuscular (IM) administration, 1 dose

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Locations (25)

GSK Investigational Site

Güglingen, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Day 0-6

Duration of Solicited General AEs

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

Time frame: 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.

Time frame: Day 0-20

Data from ClinicalTrials.gov

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Rudersberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Augsburg, Bavaria, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

...and 15 more locations

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.

Time frame: Day 0-20

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

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.

Time frame: 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.

Time frame: Day 0-20

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179

Time frame: Day 21-179

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209

Time frame: Day 180 to Day 209

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

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.

Time frame: At Day 0 and 21