Clinical trial NCT00772889: Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly
Official title: Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Elderly
Vaccine
Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 971
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).


Eligibility criteria: Inclusion Criteria:

* A male or female subject previously enrolled in study 109821 (NCT 00529516) in the \>= 65 years and 18-41 years of age groups and having received the study vaccine.
* Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* 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 30 days after vaccination.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Any vaccination against influenza since January 2008 with any seasonal influenza vaccine.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccines.
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by 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 administration of the study vaccine or planned administration during the study period.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
* Any medical conditions in which intramuscular injections are contraindicated.
* Pregnant or lactating females.
* 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 (MAEs) During Day 0 to Day 20
timeFrame: Day 0-20
measure: Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20
timeFrame: Day 0-20
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20
timeFrame: Day 0-20
Secondary outcomes:
measure: Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179
timeFrame: Day 21-179
measure: Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364
timeFrame: Day 21-364.
measure: Haemagglutination Inhibition (HI) Antibody Titers
timeFrame: Day 0-21
measure: The Number of Subjects Seropositive to HI Antibodies
timeFrame: Day 0-21
measure: The Number of Subjects Seroprotected by HI Antibodies
timeFrame: Day 0-21
measure: The Number of Subjects Seroconverted to HI Antibodies
timeFrame: At Day 21
measure: HI Antibody Seroconversion Factors (SCF)
timeFrame: At Day 21
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364
timeFrame: Day 21-364
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Chaska
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Somers Point
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Poughkeepsie
country: United States
facility: GSK Investigational Site
state: New York
city: Carnegie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Messkirch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Haag
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hoehenkirchen-Siegertsbrunn
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Langquaid
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Ruedersdorf
country: Germany
facility: GSK Investigational Site
state: Brandenburg
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: Berlin
country: Germany
facility: GSK Investigational Site
city: Bekkestua
country: Norway
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Elverum
country: Norway
facility: GSK Investigational Site
city: Fredrikstad
country: Norway
facility: GSK Investigational Site
city: Hamar
country: Norway
facility: GSK Investigational Site
city: Haugesund
country: Norway
facility: GSK Investigational Site
city: Skien
country: Norway
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: