Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00510874
First received: August 1, 2007
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Influenza
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase I/II, Observer-Blind, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Two-Dose Series of GSK Biologicals' Candidate Influenza Vaccine GSK 1557484A Antigens With or Without Adjuvant

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Vaccine-homologous virus antibody response in subjects receiving two doses of vaccine, as demonstrated by the hemagglutination-inhibition (HI) antibody titer [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
  • The occurrence of specifically-solicited local and general signs and symptoms [ Time Frame: During a 7-day follow-up period after each dose of vaccine and overall considering both post-immunization periods. ] [ Designated as safety issue: No ]
  • The occurrence of unsolicited adverse events (AEs) [ Time Frame: During a 21-day follow-up period after the first vaccination and 21 days after the second vaccination, as well as overall. ] [ Designated as safety issue: No ]
  • The occurrence of serious adverse events (SAEs), medically-attended events, and new onset chronic diseases [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The vaccine-homologous virus antibody response in subjects receiving two doses of vaccine, as demonstrated by the HI antibody titer [ Time Frame: At Day 42. ] [ Designated as safety issue: No ]
  • The vaccine-homologous virus antibody response, and also persistence of this response. [ Time Frame: At 21 days following receipt of a first dose of vaccine through approximately 6 months ] [ Designated as safety issue: No ]

Enrollment: 780
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
Experimental: Group B Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
Experimental: Group C Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
Experimental: Group D Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
Experimental: Group E Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
Experimental: Group F (contingent)
Based on an analysis concerning immunogenicity performance at Day 42, 2 of 4 possible additional groups will be recruited, randomized, and studied
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
Experimental: Group G (contingent)
Based on an analysis concerning immunogenicity performance at Day 42, 2 of 4 possible additional groups will be recruited, randomized, and studied
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
Experimental: Group H (contingent)
Based on an analysis concerning immunogenicity performance at Day 42, 2 of 4 possible additional groups will be recruited, randomized, and studied
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
Experimental: Group I (contingent)
Based on an analysis concerning immunogenicity performance at Day 42, 2 of 4 possible additional groups will be recruited, randomized, and studied
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses

Detailed Description:

The study has five core arms and the stratification is based on site and age. In addition, there are 4 possible contingent groups of which 2 will be studied based on an analysis concerning immunogenicity performance at Day 42 in core groups above.

  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.
  • Good general health as assessed by medical history and physical examination.
  • Access to a consistent means of telephone contact
  • Written informed consent obtained from the subject.
  • Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion Criteria:

  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Blood pressure abnormalities
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
  • Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary.
  • Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
  • Presence of 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 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 non-influenza vaccines within 30 days before study enrollment or during the study period.
  • 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 study period.
  • 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.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test result prior to dosing on Study Days 0 or 21.
  • Lactating or nursing.
  • Women of child bearing potential who lack a history of reliable contraceptive practices.
  • Known receipt of analgesic or antipyretic medication on the day of treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510874

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, 89104
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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00510874     History of Changes
Other Study ID Numbers: 110028
Study First Received: August 1, 2007
Last Updated: April 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Influenza
GSK 1557484A vaccine

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 May 16, 2013