Clinical trial NCT00616928: Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
Official title: A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: vaccines
immunogenicity
human
safety
influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 4561
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 Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.


Eligibility criteria: Inclusion Criteria:

* A male or female 18 years of age or greater at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
* Among subjects \> 49 years of age, stable health status within 1 month prior to enrollment.
* Access to a consistent means of telephone contact.
* Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Exclusion Criteria:

* Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
* Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Administration of any vaccines within 30 days before study enrollment.
* Previous administration of any H5N1 vaccine.
* Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
* Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to either vaccination.
* Lactating or nursing.
* Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
* Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.

Primary outcomes:
measure: Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
timeFrame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
measure: Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
timeFrame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
measure: Number of Subjects With Any Solicited Local Symptoms.
timeFrame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
measure: Number of Subjects With Any Solicited General Symptoms.
timeFrame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs).
timeFrame: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 through Day 182 and through Day 379.
measure: Number of Subjects With Medically Attended Events (MAEs)
timeFrame: From Day 0 through Day 182 and through Day 364.
Secondary outcomes:
measure: Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
timeFrame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
measure: Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
timeFrame: At Month 6 (Day 182) post Dose 1
measure: Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
timeFrame: At Month 6 (Day 182) after Dose 1
measure: Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
timeFrame: At Month 6 (Day 182) after Dose 1
measure: Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
timeFrame: At Month 6 (Day 182) after Dose 1
measure: Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
timeFrame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
timeFrame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Peoria
country: United States
facility: GSK Investigational Site
state: Illinois
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Edison
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Poughkeepsie
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: San Angelo
country: United States
facility: GSK Investigational Site
state: Texas
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Woodstock
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Langley JM, Risi G, Caldwell M, Gilderman L, Berwald B, Fogarty C, Poling T, Riff D, Baron M, Frenette L, Sheldon E, Collins H, Shepard M, Dionne M, Brune D, Ferguson L, Vaughn D, Li P, Fries L. Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study. J Infect Dis. 2011 Jun 15;203(12):1729-38. doi: 10.1093/infdis/jir172.