Clinical trial NCT00760617: Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older
Official title: Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Elderly
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
timeFrame: Day 0-6
measure: Duration of Solicited Local AEs
timeFrame: Day 0-6
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
timeFrame: Day 0-6
measure: Duration of Solicited General AEs
timeFrame: Day 0-6
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
timeFrame: Day 0-20
measure: Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20
timeFrame: Day 0-20
measure: Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179
timeFrame: Day 21-179
measure: Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)
timeFrame: Day 0-179
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20
timeFrame: Day 0-20
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179
timeFrame: Day 21-179
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209
timeFrame: Day 180 to Day 209
Secondary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
timeFrame: At Day 0 and 21
measure: HI Antibody Titers at Day 180
timeFrame: Day 180
measure: The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21
timeFrame: At Day 0 and 21
measure: The Number of Subjects Seropositive to HI Antibodies at Day 180
timeFrame: Day 180
measure: The Number of Subjects Seroconverted to HI Antibodies at Day 21
timeFrame: Day 21
measure: The Number of Subjects Seroconverted to HI Antibodies at Day 180
timeFrame: Day 180
measure: HI Antibody Seroconversion Factor (SCF) at Day 21
timeFrame: Day 21
measure: HI Antibody SCF at Day 180
timeFrame: Day 180
measure: The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21
timeFrame: At Day 0 and 21
measure: The Number of Subjects Seroprotected to HI Antibodies at Day 180
timeFrame: Day 180
measure: 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
timeFrame: At Day 0 and 21
Other outcomes:
Locations:
city: Gueglingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Rudersberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Wolmirstedt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: