Clinical trial NCT00938392: Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly
Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: influenza infection
GSK Bio's influenza vaccine GSK2186877A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 726
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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 2008.
* 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 2.
* 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.
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature \>= 37.5°C on oral setting.
  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Any medical conditions in which intramuscular injections are contraindicated.

Primary outcomes:
measure: Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
timeFrame: At Days 0 and 21
Secondary outcomes:
measure: Number of Subjects Seropositive Against the 3 Vaccine Strains
timeFrame: At Days 0 and 21
measure: Number of Subjects Seroconverted for the 3 Vaccine Strains
timeFrame: At Day 21
measure: Seroconversion Factor for the 3 Vaccine Strains
timeFrame: At Day 21
measure: Number of Subjects Seroprotected for the 3 Vaccine Strains
timeFrame: At Days 0 and 21
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day post-vaccination period
measure: Duration of Solicited Local and General Symptoms
timeFrame: During the 7-day post-vaccination period
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 21-day post-vaccination period
measure: Number of Subjects Reporting Adverse Events of Specific Interest (AESI)
timeFrame: During the 21-day post-vaccination period
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: During the entire study period (up to Day 21)
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Velky Biel
country: Slovakia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: