Clinical trial NCT00771615: Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years
Official title: A Trial to Evaluate the Safety & Immunogenicity of Investigational Influenza Vaccine GSK1557484A in Adults 18-64 Yrs of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: human
Avian
safety
vaccines
influenza
pandemic
immunogenicity
H5N1
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.

Detailed description: All enrolled subjects will receive 1 dose of study vaccine. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 84, and 182 with a telephone safety contact on Day 364.

This Protocol Posting has been updated according to Protocol amendment, 8 Dec 08

Eligibility criteria: Inclusion Criteria:

* Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
* Written informed consent obtained from the subject.
* Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
* Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
* Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
* Subjects who the investigator believes can and will comply with the requirements of the protocol.

Exclusion Criteria:

* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* Presence of an oral temperature \>= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficiency condition including history of human immunodeficiency virus (HIV) infection.
* Receipt of systemic glucocorticoids (prednisone \>= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
* An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Administration of any vaccines within 30 days before the first study vaccine dose.
* Previous administration of any H5N1 vaccine.
* Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 12 months following test article administration. 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 (β-hCG) test result prior to 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 vaccination.
* Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of vaccination. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them.

Primary outcomes:
measure: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
timeFrame: At Day 10
measure: Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
timeFrame: At Day 10
measure: Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
timeFrame: At Day 10
Secondary outcomes:
measure: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
timeFrame: At Day 0 to Day 42 and at Day 0 to Day 182
measure: Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
timeFrame: At Day 0, Day 10, Day 42 and Day 182
measure: HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
timeFrame: At Day 0 to Day 10, Day 42 and Day 182
measure: HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
timeFrame: At Day 0, Day 10, Day 42 and Day 182
measure: Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
timeFrame: At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
measure: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
timeFrame: At Day 0 to Day 10, Day 42 and Day 182
measure: HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
timeFrame: At Day 10, Day 42 and Day 182
measure: Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
timeFrame: At Day 0, Day 10, Day 42 and Day 182
measure: Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
timeFrame: At Day 0, Day 10, Day 42 and Day 182
measure: Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
timeFrame: At Day 10
measure: Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
timeFrame: At Day 42
measure: Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
timeFrame: At Day 182
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
timeFrame: Within the 7-day (Days 0-6) post vaccination period.
measure: Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
timeFrame: Within the 7-day (Days 0-6) post vaccination period.
measure: Number of Subjects With Medically-attended Adverse Events (MAEs).
timeFrame: From Day 0 to Day 378
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
timeFrame: From Day 0 to Day 42
measure: Number of Subjects Reporting Serious Adverse Events (SAEs).
timeFrame: From Day 0 to Day 378
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Risi G, Frenette L, Langley JM, Li P, Riff D, Sheldon E, Vaughn DW, Fries L. Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months. Vaccine. 2011 Aug 26;29(37):6408-18. doi: 10.1016/j.vaccine.2011.04.072. Epub 2011 May 7.