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Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01059617
First received: January 28, 2010
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.

Condition Intervention Phase
Influenza Biological: GSK Biologicals' FluLaval® Biological: Placebo (saline) Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate Immune Responses Following A/California/7/2009 (H1N1)V-like Virus Vaccination Given 4 Months Following Seasonal Influenza Vaccination in Adults 19 to 40 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

  • Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.

  • Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164). ]
    Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  • Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.

  • Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    Titers were expressed as geometric mean antibody titers (GMTs).

  • Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.

  • Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

  • Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.

  • Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164). ]
    Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  • Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.

  • Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    Titers were expressed as geometric mean antibody titers (GMTs).

  • Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164). ]
    VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.


Secondary Outcome Measures:
  • Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: At Day 122 and Day 304 ]
    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.

  • Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: At Days 122 and 304 ]
    Titers were expressed as geometric mean antibody titers (GMTs).

  • Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: Entire study period up to Day 507 ]
    VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.

  • Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: At Days 0 and 304 ]
    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.

  • Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: At Day 0 and Day 304 ]
    Titers were expressed as geometric mean antibody titers (GMTs).

  • Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: For the entire study period up to Day 507 ]
    VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.

  • Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens [ Time Frame: Before administration of Arepanrix vaccine (Day 0 to Day 122) ]

    CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.

    The frequency was presented as number of cytokine-producing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.

    Subjects with missing results were not included.


  • Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens [ Time Frame: After the administration of Arepanrix vaccine (Day 125 to 304) ]
    CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin2, Tumor Necrosis Factor alpha or Interferongamma. The frequency was presented as number of cytokineproducing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.

  • Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs). [ Time Frame: During the entire study period (up to Day 507). ]
    pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.

  • Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs). [ Time Frame: During the entire study period (up to Day 507). ]
    MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.

  • Number of Subjects Reporting Unsolicited AEs. [ Time Frame: Up to 21-day (Days 0-20) after vaccination ]

    An unsolicited adverse event is any adverse event (i.e. 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) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

    Unsolicited AEs were collected after the administration of the Flulaval vaccine or the placebo dose and the data has been pooled based on the vaccination received at Day 0.


  • Number of Subjects Reporting Unsolicited AEs. [ Time Frame: Within 84 days following first dose or 63 days following second dose of vaccine. ]

    Unsolicited AEs were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.

    An unsolicited adverse event is any adverse event (i.e. 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) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.


  • Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (up to Day 507). ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination.

  • Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). [ Time Frame: Up to Day 234 ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination. Missing values will be added once they become available.

  • Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs). [ Time Frame: Within Days 0-233 ]
    MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.

  • Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs). [ Time Frame: Within Days 0-233 ]
    pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.

  • Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group. [ Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination. ]

    Solicited local symptoms assessed were pain, redness and swelling and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).

    Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).


  • Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group. [ Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination. ]

    Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).

    Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.


  • Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group [ Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination. ]

    Solicited local symptoms assessed were pain, redness and swelling and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.

    Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).


  • Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group. [ Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination. ]

    Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.

    Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.


  • Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges. [ Time Frame: On Days 0, 21, 122 and 164 ]
    Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).

  • Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges. [ Time Frame: On Days 0, 21, 122 and 164 ]

    Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatise (AP), creatinine (CREA), blood urea nitrogen (BUN) and bilirubin (BIL) (total (T) and direct (D)).

    For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).


  • Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges. [ Time Frame: At Day 304 ]
    Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).

  • Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges. [ Time Frame: At Day 304 ]
    Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), creatinine (CREA), blood urea nitrogen (BUN), and bilirubin (BIL) (total (T) and direct (D)). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).

  • Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: Before vaccination and at Days 7, 14, 21 and 122 ]

    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.

    Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14 and 21 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.


  • Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: Before vaccination and at Days 7, 14, 21 and 122 ]
    Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.

  • Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: At Days 122, 129, 136, 143, 150, 157 and 164. ]
    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.

  • Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. [ Time Frame: At Days 122, 129, 136, 143, 150, 157 and 164. ]
    Titers were expressed as geometric mean antibody titers (GMTs).

  • Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: Before vaccination and at Days 7, 14, 21 and 122 ]

    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.

    Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.


  • Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: Before vaccination and at Days 7, 14, 21 and 122 ]
    Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.

  • Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: At Days 122, 129, 136, 143, 150, 157 and 164. ]
    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.

  • Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain. [ Time Frame: At Days 122, 129, 136, 143, 150, 157 and 164. ]
    Titers were expressed as geometric mean antibody titers (GMTs).


Enrollment: 133
Actual Study Start Date: February 9, 2010
Study Completion Date: October 21, 2011
Primary Completion Date: January 14, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flulaval/Arepanrix Group
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
Biological: GSK Biologicals' FluLaval®
Intramuscular injection
Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A
Intramuscular injections
Experimental: Flulaval/Unadjuvanted Arepanrix Group
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
Biological: GSK Biologicals' FluLaval®
Intramuscular injection
Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A
Intramuscular injections
Experimental: Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
Biological: Placebo (saline)
Intramuscular injection
Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A
Intramuscular injections
Experimental: Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
Biological: Placebo (saline)
Intramuscular injection
Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A
Intramuscular injections

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
  • Written informed consent obtained from the subject.
  • Male or female adults, 19-40 years of age at the time of the first vaccination.
  • Body weight of at least 110 pounds (49.9 kg).
  • Safety laboratory tests results within the parameters specified by protocol.
  • Satisfactory baseline medical assessment by physical examination (stable health status with no exclusionary conditions). Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrollment.
  • Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy, or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria:

  • Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine
  • A medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
  • Prior receipt at any time of any seasonal influenza vaccine.
  • Planned administration of any vaccine not foreseen by the study protocol (including any influenza vaccine other than the study vaccine) between Days 0 and the Day 164 phlebotomy.
  • Administration of any licensed vaccine within 30 days before the first study vaccine dose.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Receipt of systemic glucocorticoids (e.g., prednisone ≥ 0.5 mg/kg/day, or ≥ 10 mg/day [whichever is less] for more than 14 consecutive days) within one month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within six months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
  • Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • History of anemia.
  • Presence of a temperature ≥ 38.0ºC (≥100.4ºF), (oral temperature assessment preferred), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (No laboratory testing is required.)
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome within six weeks of receipt of any vaccine.
  • Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to any vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-HCG) test result prior to first vaccination.
  • Lactating or nursing women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059617

Locations
United States, Massachusetts
GSK Investigational Site
Milford, Massachusetts, United States, 01757
United States, North Carolina
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113483
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113483
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113483
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113483
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113483
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113483
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01059617     History of Changes
Other Study ID Numbers: 113483
Study First Received: January 28, 2010
Results First Received: January 31, 2012
Last Updated: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Pandemic
GSK Bio's influenza vaccine GSK2340274A
H1N1
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017