Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Adults.

GlaxoSmithKline1 site in 1 country726 target enrollmentJuly 30, 2009

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: GlaxoSmithKline
Enrollment: 726
Locations: 1
Primary Endpoint: Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.

Registry

clinicaltrials.gov

Start Date

July 30, 2009

End Date

October 5, 2009

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
•A man or woman 65 years of age or older at the time of vaccination.
•Written informed consent obtained from the subject.
•Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.

Exclusion Criteria

•Any confirmed or suspected influenza illness within the last 6 months.
•Previous vaccination against influenza with any seasonal vaccine since December
•Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, 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 a vaccine not foreseen by the study protocol up to Visit
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Outcomes

Primary Outcomes

Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains

Time Frame: At Days 0 and 21

Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.

Secondary Outcomes

Number of Subjects Seroprotected for the 3 Vaccine Strains(At Days 0 and 21)
Duration of Solicited Local and General Symptoms(During the 7-day post-vaccination period)
Number of Subjects Reporting Adverse Events of Specific Interest (AESI)(During the 21-day post-vaccination period)
Number of Subjects Seropositive Against the 3 Vaccine Strains(At Days 0 and 21)
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms(During the 7-day post-vaccination period)
Number of Subjects Seroconverted for the 3 Vaccine Strains(At Day 21)
Seroconversion Factor for the 3 Vaccine Strains(At Day 21)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 21-day post-vaccination period)
Number of Subjects Reporting Serious Adverse Events (SAEs)(During the entire study period (up to Day 21))