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

Condition(s) targeted: Influenza Disease; Influenza Vaccines

Intervention: GSK Bio's influenza vaccine GSK2186877A (Biological); Fluarix (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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).

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

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

Duration of Solicited Local AEs

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

Duration of Solicited General AEs

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179

Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20

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

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

Secondary outcome:

Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21

HI Antibody Titers at Day 180

The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21

The Number of Subjects Seropositive to HI Antibodies at Day 180

The Number of Subjects Seroconverted to HI Antibodies at Day 21

The Number of Subjects Seroconverted to HI Antibodies at Day 180

HI Antibody Seroconversion Factor (SCF) at Day 21

HI Antibody SCF at Day 180

The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21

The Number of Subjects Seroprotected to HI Antibodies at 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

GSK Investigational Site, Berlin 10435, Germany

GSK Investigational Site, Berlin 12627, Germany

GSK Investigational Site, Berlin 13347, Germany

GSK Investigational Site, Berlin 13359, Germany

GSK Investigational Site, Hamburg 22335, Germany

GSK Investigational Site, Hamburg 22415, Germany

GSK Investigational Site, Rotterdam 3001 DC, Netherlands

GSK Investigational Site, Rotterdam 3011 EN, Netherlands

GSK Investigational Site, Eskilstuna SE-631 88, Sweden

GSK Investigational Site, Karlskrona SE-371 41, Sweden

GSK Investigational Site, Uppsala SE-751 85, Sweden

GSK Investigational Site, Gueglingen, Baden-Wuerttemberg 74363, Germany

GSK Investigational Site, Mannheim, Baden-Wuerttemberg 68161, Germany

GSK Investigational Site, Rudersberg, Baden-Wuerttemberg 73635, Germany

GSK Investigational Site, Weinheim, Baden-Wuerttemberg 69469, Germany

GSK Investigational Site, Augsburg, Bayern 86150, Germany

GSK Investigational Site, Essen, Nordrhein-Westfalen 45359, Germany

GSK Investigational Site, Koeln, Nordrhein-Westfalen 51069, Germany

GSK Investigational Site, Mainz, Rheinland-Pfalz 55131, Germany

GSK Investigational Site, Rhaunen, Rheinland-Pfalz 55624, Germany

GSK Investigational Site, Dresden, Sachsen 01067, Germany

GSK Investigational Site, Freital, Sachsen 01705, Germany

GSK Investigational Site, Leipzig, Sachsen 04103, Germany

GSK Investigational Site, Magdeburg, Sachsen-Anhalt 39112, Germany

GSK Investigational Site, Wolmirstedt, Sachsen-Anhalt 39326, Germany

Starting date: October 2008
Last updated: October 4, 2012