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Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00506350
First received: July 24, 2007
Last updated: October 6, 2016
Last verified: October 2016

July 24, 2007
October 6, 2016
August 2007
October 2009   (final data collection date for primary outcome measure)
  • Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Geometric mean titres [ Time Frame: Day 0, Day 21 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Seroconversion rates [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Seroconversion rate for anti-HA antibody response is defined as the percentage of vaccinees who have 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 4-fold increase in post-vaccination titer.
  • Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Seroconversion factors [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Seroconversion factor is defined as the fold increase in serum anti-HA antibody GMTs post-vaccination compared to Day 0.
  • Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Seroprotection rates [ Time Frame: Day 0, Day 21 ] [ Designated as safety issue: No ]
    Seroprotection rate is defined as the percentage of vaccinees with a serum anti-HA antibody titer >= 1:40 that usually is accepted as indicating protection.
(1) humoral immune response (2) adverse events (AEs) and serious Aes;
Complete list of historical versions of study NCT00506350 on ClinicalTrials.gov Archive Site
  • Humoral immune response in terms of anti-HA antibodies and neutralising antibodies (all groups): Geometric mean titres [ Time Frame: days 0, 21, 42, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies and neutralising antibodies (all groups): Seroconversion rates [ Time Frame: days 7, 21 42, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
    Seroconversion rate for anti-HA antibody response is defined as the percentage of vaccinees who have 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 4-fold increase in post-vaccination titer.
  • Humoral immune response in terms of anti-HA antibodies and neutralising antibodies (all groups): Seroconversion factors [ Time Frame: days 7, 21 42, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
    Seroconversion factor is defined as the fold increase in serum anti-HA antibody GMTs post-vaccination compared to Day 0.
  • Humoral immune response in terms of anti-HA antibodies and neutralising antibodies (all groups): Seroprotection rates [ Time Frame: days 0, 7, 14, 21, 28, 35, 42, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
    Seroprotection rate is defined as the percentage of vaccinees with a serum anti-HA antibody titer >= 1:40 that usually is accepted as indicating protection.
  • Cell-mediated immunity (groups 1, 5 and 9): Frequency of antigen-specific CD4/CD8 cells per 10E6 in tests identified as producing at least two out of four different cytokines [ Time Frame: days 0, 21, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
(1) humoral immune response ; (2) cell-mediated immune response
Not Provided
Not Provided
 
Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults
Evaluate the Reactogenicity & Immunogenicity of 1 or 2 Booster Administrations of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults Aged Between 19 & 61 Years
The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)
The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. The persistence of antibodies will be analysed at 6, 12, 18 and 24 months.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
  • Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
    A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
  • Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
    Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
  • Experimental: H5N1 non-AD Formulation 1 Primed Group
    Subjects primed with 2 doses of a non-adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 1 in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
  • Experimental: H5N1 non-AD Formulation 2 Primed Group
    Subjects primed with 2 doses of a non-adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 2 in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
  • Experimental: H5N1 non-AD Formulation 3 Primed Group
    Subjects primed with 2 doses of a non-adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 3 in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
  • Experimental: H5N1 non-AD Formulation 4 Primed Group
    Subjects primed with 2 doses of a non-adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 4 in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
  • Experimental: H5N1 AD Formulation 1 Primed Group
    Subjects primed with 2 doses of an adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 1 in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
  • Experimental: H5N1 AD Formulation 2 Primed Group
    Subjects primed with 2 doses of an adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 2 in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
  • Experimental: H5N1 AD Formulation 3 Primed Group
    Subjects primed with 2 doses of an adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 3 in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
  • Experimental: H5N1 AD Approved Formulation Primed Group
    Subjects primed with 2 doses of approved formulation of adjuvanted H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
  • Experimental: Control Group
    Unprimed subjects receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
    Intervention: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
October 2009
October 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 should be enrolled in the study.
  • For previously primed subjects: participation in the primary study (NCT00309634).
  • For unprimed subjects: male or female between and including, 19 and 61 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 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 (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • For unprimed subjects who did not participate in the primary study (NCT00309634): Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a licenced vaccine not foreseen by the study protocol within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) of the first dose of vaccine(s).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Applicable for control group only: previous vaccination with a pandemic candidate vaccine or a vaccine containing the investigational vaccine adjuvant.
  • History of hypersensitivity to vaccines.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures.
  • Acute disease at the time of enrolment.
  • Acute or chronic, 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.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
  • Lactating female.
  • History of chronic alcohol consumption and/or drug abuse
All
19 Years to 61 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00506350
109817
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

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