Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00693706
First received: June 2, 2008
Last updated: February 7, 2013
Last verified: February 2013

June 2, 2008
February 7, 2013
June 2008
March 2009   (final data collection date for primary outcome measure)
  • Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post vaccination period ] [ Designated as safety issue: No ]
    Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.
  • Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post vaccination period ] [ Designated as safety issue: No ]
    Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.
  • Number of Subjects With Medically Attended Adverse Events (MAEs). [ Time Frame: During the entire study period (Days 0-182) ] [ Designated as safety issue: No ]
    Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.
  • Number of Subjects With New Onset of Chronic Diseases (NOCDs). [ Time Frame: During the entire study period (Days 0-182) ] [ Designated as safety issue: No ]
    NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
  • Number of Subjects With Unsolicited Adverse Events (AEs). [ Time Frame: During the 90-day (Days 0-89) post-vaccination period ] [ Designated as safety issue: No ]
    Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
  • Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Days 0-182) ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.
  • Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
  • Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
  • Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
  • Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. [ Time Frame: At Day 0 and Day 21 ] [ Designated as safety issue: No ]
    GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
  • Occurrence of specifically-solicited local and general signs and symptoms. [ Time Frame: During a 7-day follow-up period after vaccination. ]
  • Occurrence of serious adverse events, medically attended AEs, and NOCDs. [ Time Frame: During the entire study period (Day 0 to 180). ]
  • Occurrence of unsolicited adverse events. [ Time Frame: During the 90-day period after vaccination. ]
  • Influenza A and B antibody titers (GMT, SPR, SCR, GMFR). [ Time Frame: On Days 0 and 21 ]
Complete list of historical versions of study NCT00693706 on ClinicalTrials.gov Archive Site
Not Provided
Non-inferiority of Influenza A and B antibody titers (GMT) compared to a licensed influenza vaccine [ Time Frame: Day 21 ]
Not Provided
Not Provided
 
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults

The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Influenza Vaccines
  • Seasonal Influenza
  • Biological: Trivalent influenza vaccine GSK 138842A
    IM injection on Day 0
  • Biological: Fluarix
    IM injection on Day 0
  • Experimental: GSK 1388442A Group
    Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
    Intervention: Biological: Trivalent influenza vaccine GSK 138842A
  • Active Comparator: Fluarix Group
    Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
    Intervention: Biological: Fluarix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
  • Access to a telephone for scheduled follow-up telephone contacts
  • Ability to provide written informed consent
  • Healthy subjects as established by medical history and physical examination before entering into the study
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
  • Receipt of systemic glucocorticoids within 30 days of study enrollment
  • Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
  • Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
  • Previous vaccination against influenza (2007-2008 influenza season)
  • History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
  • History of Guillain-Barre Syndrome (GBS)
  • Acute disease, febrile illness, or upper respiratory infection at screening.
  • History of splenectomy
  • Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination
  • Acquired or congenital coagulation disorders or known thrombocytopenia
  • Current treatment with warfarin or heparin derivatives
  • Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
  • Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza
Both
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00693706
110127
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP