Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00771615
First received: October 10, 2008
Last updated: July 2, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Influenza Disease Caused by an Influenza A Virus With Pandemic Potential, Sub-type H5N1
Biological: GSK influenza virus H5N1 vaccine 1557484A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Trial to Evaluate the Safety & Immunogenicity of Investigational Influenza Vaccine GSK1557484A in Adults 18-84 Yrs of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Vaccine-homologous virus antibody response measured by:Seroconversion rate (SCR), proportion of subjects with Hl titer >= 40, Geometric mean titer (GMT) [ Time Frame: Prior to and 10 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccine-homologous virus antibody response measured by Seroconversion rate (SCR), proportion of subjects with HI titer >= 40, Geometric mean fold rise (GMFR) [ Time Frame: 0, 10, 42, and 182 days after vaccination. ] [ Designated as safety issue: No ]
  • The occurrence of all unsolicited adverse events. [ Time Frame: Days 0 to 42 post-vaccination. ] [ Designated as safety issue: No ]
  • The occurrence of SAEs and medically-attended events [ Time Frame: Days 0 to 364 post vaccination. ] [ Designated as safety issue: No ]
  • Vaccine-heterologous virus antibody response measured by GMT, SCR, proportion of subjects with HI titer >= 40, GMFR [ Time Frame: 0, 10, 42, and 182 days after vaccination. ] [ Designated as safety issue: No ]
  • Homologous and drift variant H5N1 virus immune responses as assessed by reciprocal MN (microneutralization) titer GMT, reciprocal MN titer SCR, proportion of subjects with MN titers >= 40 [ Time Frame: 0, 10, 42, and 182 days after vaccination. ] [ Designated as safety issue: No ]
  • The occurrence of specifically-solicited local and general safety signs and symptoms [ Time Frame: Days 0 to 6 post vaccination. ] [ Designated as safety issue: No ]

Enrollment: 469
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C2 Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Experimental: A Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Experimental: C1 Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Experimental: B2 Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Experimental: B1 Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Experimental: E1 Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Experimental: E2 Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Experimental: D1 Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Experimental: D2 Biological: GSK influenza virus H5N1 vaccine 1557484A
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771615

Locations
United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35802
United States, California
GSK Investigational Site
Anaheim, California, United States, 92801
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33143
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
United States, Montana
GSK Investigational Site
Missoula, Montana, United States, 59801
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89130
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 4J6
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00771615     History of Changes
Other Study ID Numbers: 111729
Study First Received: October 10, 2008
Last Updated: July 2, 2010
Health Authority: Canada: Biologics and Genetics Therapeutic Directorate (B>D)
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Avian
influenza
H5N1
pandemic
vaccines
human
safety
immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014