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Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00374842
First received: September 8, 2006
Last updated: March 7, 2013
Last verified: February 2013

September 8, 2006
March 7, 2013
October 2006
November 2006   (final data collection date for primary outcome measure)
  • Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. [ Time Frame: At Day 0 and at Day 21. ] [ Designated as safety issue: No ]
    Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
  • Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. [ Time Frame: At Day 0 and at Day 21. ] [ Designated as safety issue: No ]
    A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
  • Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed [ Time Frame: At Day 21. ] [ Designated as safety issue: No ]
    Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.
  • Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. [ Time Frame: At Day 21. ] [ Designated as safety issue: No ]
    Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).
Immune response at days 0 and 21
Complete list of historical versions of study NCT00374842 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within the 7-day follow-up period (Days 0-6) after vaccination ] [ Designated as safety issue: No ]
    Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within the 7-day follow-up period (Days 0-6) after vaccination ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.
  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within the 30-day follow-up period (Days 0-29) after vaccination ] [ Designated as safety issue: No ]
    An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.
  • Number of Subjects With Any and Related Serious Adverse Events (SAEs) [ Time Frame: From study start to study end, from Day 0 to Day 30 ] [ Designated as safety issue: No ]
    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 occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Safety during 30 days
Not Provided
Not Provided
 
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Influenza
  • Biological: Fluarix™
    GlaxoSmithKline Biologicals' licensed influenza vaccine
  • Biological: GSK1247446A
    Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
  • Experimental: GSK1247446A Formulation 1 Group
    Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
    Intervention: Biological: GSK1247446A
  • Experimental: GSK1247446A Formulation 2 Group
    Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
    Intervention: Biological: GSK1247446A
  • Active Comparator: Fluarix Group
    Subjects aged 18 - 59 years at the time of enrolment received one dose of the 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
300
November 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A male or female aged 18-59 years at the time of the first vaccination.
  • Free of obvious health problems

Exclusion Criteria:

  • Use of non-registered products
  • Administration of immune-modifying drugs.
  • Administration of vaccine 30 days before enrolment in study.
  • Immunosuppressive or immunodeficient condition.
  • Hypersensitivity to a previous dose of influenza vaccine
  • Previous vaccination against influenza in 2006
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
  • History of confirmed influenza infection within the last 12 Months.
  • Acute disease at the time of enrolment/vaccination.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine
Both
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00374842
108656
Not Provided
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