Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00430521
First received: February 1, 2007
Last updated: February 9, 2012
Last verified: January 2012

February 1, 2007
February 9, 2012
February 2007
October 2008   (final data collection date for primary outcome measure)
  • Serum anti-haemagglutinin (HA)antibody titers, in Group C [ Time Frame: At Day 0, Month 6, Month 6+ 7 Days, Month 6 + 21 Days ] [ Designated as safety issue: No ]
  • Geometric mean titres (GMTs) of H5N1 antibody titers [ Time Frame: At Day 0, Month 6, Month 6+ 7 Days, Month 6+ 21 Days ] [ Designated as safety issue: No ]
  • Seroconversion rates (SC) [ Time Frame: At Month 6, Month 6+ 7 Days, Month 6+ 21 Days ] [ Designated as safety issue: No ]
  • Seroconversion factors [ Time Frame: At Month 6, Month 6+ 7 Days, Month 6+ 21 Days ] [ Designated as safety issue: No ]
  • Seroprotection rates [ Time Frame: At Day 0, Month 6, Month 6+ 7 Days, Month 6+ 21 Days ] [ Designated as safety issue: No ]
  • Occurence of solicited local and general signs and symptoms [ Time Frame: During a 7-day follow-up period after each vaccination and overall. ] [ Designated as safety issue: Yes ]
  • Occurence of unsolicited local and general signs and symptoms [ Time Frame: During a 30-day follow-up period after priming vaccination(s) and booster vaccination, and overall. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study. ] [ Designated as safety issue: Yes ]
  • Humoral immune response at Month 6
  • Safety during the entire study
  • Reactogenicity for 30 days
Complete list of historical versions of study NCT00430521 on ClinicalTrials.gov Archive Site
  • GMTs of anti-HA antibody titres [ Time Frame: At Day 0, Day 21, Day 42, Month 6/12, Month 6/12 + 7days, Month 6/12 + 21 days, Month 18 ] [ Designated as safety issue: No ]
  • Seroconversion rates [ Time Frame: At Day 21, Day 42, Month 6/12, Month .6/12 + 7days, Month 6/12 + 21 days, Month 18. ] [ Designated as safety issue: No ]
  • In addition, humoral immune response in terms of anti-HA antibodies: Seroconversion factors [ Time Frame: At Day 21, Day 42, Month 6/12, Month .6/12 + 7days, Month 6/12 + 21 days, Month 18 ] [ Designated as safety issue: No ]
  • Seroprotection rates [ Time Frame: At Day 0, Day 21, Day 42, Month 6/12, Month .6/12 + 7days, Month 6/12 + 21 days, Month 18 ] [ Designated as safety issue: No ]
  • Frequency of influenza-specific CD4/CD8 T-cells per 10E6 in tests producing at least two different cytokines [ Time Frame: At Day 0, Month 6/12, Month 6/12 + 7 Days, Month 6/12 + 21 Days and Month 18 ] [ Designated as safety issue: No ]
  • Frequency of influenza-specific CD4/CD8 T-cells per 10E6 in tests producing at least CD40L and another signal molecule (IL-2, IFN-γ, TNF-α) [ Time Frame: At Day 0, Month 6/12, Month 6/12 + 7 Days, Month 6/12 + 21 Days and Month 18 ] [ Designated as safety issue: No ]
  • Frequency of influenza-specific CD4/CD8 T-cells per 10E6 in tests producing at least IL-2 and another signal molecule (CD40L, IFN-γ, TNF-α) [ Time Frame: At Day 0, Month 6/12, Month 6/12 + 7 Days, Month 6/12 + 21 Days and Month 18 ] [ Designated as safety issue: No ]
  • Frequency of influenza-specific CD4/CD8 T-cells per 10E6 in tests producing at least TNF-α and another signal molecule (IL-2, IFN-γ, CD40L) [ Time Frame: At Day 0, Month 6/12, Month 6/12 + 7 Days, Month 6/12 + 21 Days and Month 18 ] [ Designated as safety issue: No ]
  • Humoral immune response up to Month 18
  • Cellular immune response at 6, 12 and 18 months
Not Provided
Not Provided
 
Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
Reactogenicity and Immunogenicity Study of GlaxoSmithKline Biologicals Pandemic Influenza Vaccine (GSK1119711A) Administered According to Different Vaccination Schedules

The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pandemic Flu
  • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
    2 or 3 doses, intramuscular injection, at different time points.
  • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
    2 or 3 doses, intramuscular injection, at different time points.
  • Experimental: Group A
    Subjects received two doses of vaccine
    Intervention: Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
  • Experimental: Group B
    Subjects received two doses of vaccine
    Intervention: Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
  • Experimental: Group C
    Subjects received two doses of vaccine
    Interventions:
    • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
    • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
  • Experimental: Group D
    Subjects received two doses of vaccine
    Interventions:
    • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
    • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
  • Experimental: Group E
    Subjects received three doses of vaccine
    Intervention: Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
  • Experimental: Group F
    Subjects received three doses of vaccine
    Intervention: Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
  • Experimental: Group G
    Subjects received three doses of vaccine
    Interventions:
    • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
    • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
  • Experimental: Group H
    Subjects received three doses of vaccine
    Interventions:
    • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
    • Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
512
October 2008
October 2008   (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 between, and including, 18 and 60 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects 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 of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

  • Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
  • History of vaccination with investigational influenza pandemic vaccine.
  • History of administration of an experimental/licensed vaccine
  • Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of chronic alcohol consumption and/or drug abuse.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the candidate vaccine or during the study.
  • Lactating women.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00430521
107495
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2012

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