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A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01144299
First received: June 10, 2010
Last updated: October 27, 2011
Last verified: October 2011

June 10, 2010
October 27, 2011
June 2010
July 2010   (final data collection date for primary outcome measure)
  • Hemagglutination Inhibition (HI) Antibody Titer [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
    Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
  • Number of Seroprotected Subjects [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
    A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
  • Number of Seroconverted Subjects [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
  • Seroconversion Factor [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
  • Seroprotection Power [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40
  • Evaluation of the humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Evaluation of the humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01144299 on ClinicalTrials.gov Archive Site
  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.
  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ] [ Designated as safety issue: No ]
    An AE is 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
  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the entire study period (From Day 0 up to Day 21) ] [ Designated as safety issue: No ]
    An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
  • Percentage, intensity, duration and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [ Time Frame: During 21 days following vaccination ] [ Designated as safety issue: No ]
  • Percentage, intensity and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period (From Day 0 up to Day 21) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults
A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™/Influsplit SSW® 2010/2011 in People Aged 18 Years or Above

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Seasonal Influenza
Biological: Fluarix™/Influsplit SSW®
Single intramuscular dose on Day 0
  • Experimental: Fluarix Adult Group
    Subjects aged 18 to 60 years received one dose of Fluarix™.
    Intervention: Biological: Fluarix™/Influsplit SSW®
  • Experimental: Fluarix Elderly Group
    Subjects aged > 60 years received one dose of Fluarix™.
    Intervention: Biological: Fluarix™/Influsplit SSW®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female aged 18 years or above at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical 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, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
  • Administration of an influenza vaccine within 6 months preceding the study start.
  • Administration of an influenza vaccine other than the study vaccine during the entire study
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Not stabilized or clinically serious chronic underlying disease.
  • Lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01144299
114292
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2011

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