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Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
This study is ongoing, but not recruiting participants.
First Received: January 28, 2008   Last Updated: October 15, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00616928
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: GSK 1557484A
Phase III

MedlinePlus related topics: Flu
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HI antibody titer for younger adults age 18 to 64 years and older adults age >64 years [ Time Frame: At 21 days after the second dose of GSK 1557484A vaccine ]
  • The occurrence of specifically-solicited local and general signs and symptoms, and overall per subject considering both post-immunization periods [ Time Frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration ]
  • The occurrence of all unsolicited adverse events [ Time Frame: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84) ]
  • The occurrence of serious adverse events and medically-attended events [ Time Frame: Day 0 through Day 182. ]

Secondary Outcome Measures:
  • HI antibody titer for younger adults age 18 to 60 years and older adults age >60 years [ Time Frame: At 21 days after the second dose of GSK 1557484A vaccine ]
  • HI antibody titer for younger adults age 18 to 64 years and older adults age >64 years. [ Time Frame: At 6 months after the first dose of GSK 1557484A vaccine ]
  • Vaccine-homologous virus and drift variant H5N1 virus antibody responses, as assessed by microneutralization assays, in subjects receiving 2 doses of study vaccine.

Estimated Enrollment: 4440
Study Start Date: January 2008
Estimated Study Completion Date: September 2008
Detailed Description:

A Phase 3, observer-blind, placebo-controlled, multi-center study designed to evaluate the safety and immunogenicity of an investigational vaccination regimen in adults aged 18 years or older. A total of 4440 subjects are to be enrolled in the study at 35 to 50 study centers in the United States and Canada, of whom ~3330 are to receive study vaccine and ~1110 are to receive placebo. Subjects will attend formal study center visits for study assessments on Days 0, 21, 42, and 182. In addition, a telephone visit will be conducted on Day 84.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 subject unable/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 (HIV) 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 (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 182 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 (including egg proteins or mercurial preservatives); 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 (beta-hCG) test result prior to either vaccination.
  • Lactating or nursing.
  • Women of child bearing potential (i.e., neither post-menopausal for one year nor surgically-sterilized) 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616928

  Show 39 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110464
Study First Received: January 28, 2008
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00616928     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Products and Foods Branch, Health Canada

Keywords provided by GlaxoSmithKline:
influenza
vaccines
human
safety
immunogenicity

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

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

ClinicalTrials.gov processed this record on May 07, 2009