Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00985673
First received: September 24, 2009
Last updated: June 14, 2012
Last verified: December 2011
  Purpose

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.


Condition Intervention Phase
Influenza A Virus, H1N1 Subtype
Influenza Infection
Biological: GSK2340274A
Biological: GSK2340273A
Biological: Seasonal trivalent influenza vaccine (TIV)
Biological: Saline placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Safety and Immunogenicity of an A/California/7/2009 (H1N1)V-like Vaccine GSK2340274A or GSK2340273A Co-administered With Trivalent Inactivated Seasonal Influenza Vaccine in Adults 19 to 40 Years of Age.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [ Time Frame: 21 days after the second dose of Arepanrix vaccine (at Day 42). ] [ Designated as safety issue: No ]

    The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone.

    Titers were expressed as geometric mean antibody titers (GMTs).


  • Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [ Time Frame: 21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42) ] [ Designated as safety issue: No ]

    The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.

    Titers were expressed as geometric mean antibody titers (GMTs).



Secondary Outcome Measures:
  • Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α). [ Time Frame: On Days 0, 7, 21, 28, 42, 63 and 182 ] [ Designated as safety issue: No ]

    Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.

    Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.


  • Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α). [ Time Frame: On Days 0, 7, 21, 28, 42, 63 and 182 ] [ Designated as safety issue: No ]

    Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.

    Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.


  • Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed [ Time Frame: On Days 0, 7, 21, 28, 42, 63 and 182 ] [ Designated as safety issue: No ]
    Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.

  • Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed [ Time Frame: On Days 0, 7, 21, 28, 42, 63 and 182 ] [ Designated as safety issue: No ]
    Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.

  • Number of Subjects Reporting Solicited Local Symptoms. [ Time Frame: During a 7-day follow-up period (Days 0-6) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling

  • Number of Subjects Reporting Solicited General Symptoms. [ Time Frame: During a 7-day follow-up period (Days 0-6) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).

  • Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed [ Time Frame: On Days 0, 7, 21, 28, 42, 63 and 182 ] [ Designated as safety issue: No ]
    Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.

  • Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: Within the 84-day (Days 0-83) post-vaccination period. ] [ Designated as safety issue: No ]
    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 Medically Attended Visits (MAEs). [ Time Frame: During the entire study period (Days 0-368). ] [ Designated as safety issue: No ]
    The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.

  • Number of Subjects Reporting Potential Immune Diseases (pIMDs). [ Time Frame: During the entire study period (Days 0-406). ] [ Designated as safety issue: No ]
    The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

  • Number of Subjects Reporting Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Days 0-329). ] [ Designated as safety issue: No ]

    The day 329 was the last contact day with the subjects reporting serious adverse events.

    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.


  • Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed [ Time Frame: On Days 0, 7, 21, 28, 42, 63 and 182 ] [ Designated as safety issue: No ]
    Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.

  • Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain. [ Time Frame: On Days 0, 21, 42, 63 and 182 ] [ Designated as safety issue: No ]

    Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization.

    Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).

    Microneutralization testing was cancelled.


  • Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain. [ Time Frame: On Days 0, 21, 42, 63 and 182 ] [ Designated as safety issue: No ]

    Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).

    The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity.

    Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off.

    Microneutralization testing was cancelled.


  • Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain. [ Time Frame: On Days 0, 21, 42, 63 and 182 ] [ Designated as safety issue: No ]

    Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).

    Vaccine Response Rate 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.

    Microneutralization testing was cancelled.


  • Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [ Time Frame: 21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group) ] [ Designated as safety issue: No ]

    The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone.

    Titers were expressed as geometric mean antibody titers (GMTs).


  • Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [ Time Frame: 21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group) ] [ Designated as safety issue: No ]

    The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.

    Titers were expressed as geometric mean antibody titers (GMTs).


  • Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [ Time Frame: 21 days after the second dose of the pandemic vaccine (at Day 63) ] [ Designated as safety issue: No ]

    The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine.

    Titers were expressed as geometric mean antibody titers (GMTs).


  • Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. [ Time Frame: 21 days after the Flulaval vaccination (at Day 21). ] [ Designated as safety issue: No ]

    The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.

    Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.

    Titers were expressed as geometric mean antibody titers (GMTs).


  • Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. [ Time Frame: 21 days after the Flulaval vaccination (at Day 21). ] [ Designated as safety issue: No ]

    The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.

    Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.

    Titers were expressed as geometric mean antibody titers (GMTs).


  • Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. [ Time Frame: 21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups) ] [ Designated as safety issue: No ]

    The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.

    Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.

    Titers were expressed as geometric mean antibody titers (GMTs).


  • Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. [ Time Frame: 21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups) ] [ Designated as safety issue: No ]

    The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.

    Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.

    Titers were expressed as geometric mean antibody titers (GMTs).


  • Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. [ Time Frame: On Days 0, 21, 42 and 63 ] [ Designated as safety issue: No ]
    Titers were expressed as geometric mean antibody titers (GMTs).

  • Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. [ Time Frame: At Day 182 ] [ Designated as safety issue: No ]
    Titers were expressed as geometric mean antibody titers (GMTs).

  • Number of Seroconverted Subjects for Antibodies Against A/ California Strain. [ Time Frame: At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups ] [ Designated as safety issue: No ]

    Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer.

    Seroconversion defined as:

    For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer


  • Number of Seroprotected Subjects for Antibodies Against A/California Strain. [ Time Frame: At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups. ] [ Designated as safety issue: No ]
    Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.

  • Seroconversion Factor for Antibodies Against A/California Strain. [ Time Frame: At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups ] [ Designated as safety issue: No ]
    Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.

  • Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. [ Time Frame: At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group ] [ Designated as safety issue: No ]

    Seroconversion defined as:

    For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

    For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.


  • Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains [ Time Frame: At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group ] [ Designated as safety issue: No ]

    Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus.

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

    For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.


  • Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. [ Time Frame: At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group ] [ Designated as safety issue: No ]

    Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer.

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

    For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.


  • Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains [ Time Frame: on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups ] [ Designated as safety issue: No ]

    Seroconversion defined as:

    For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.


  • Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains [ Time Frame: At Day 182 from Day 0 ] [ Designated as safety issue: No ]

    Seroconversion defined as:

    For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.


  • Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. [ Time Frame: before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups ] [ Designated as safety issue: No ]

    Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.


  • Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. [ Time Frame: At Day 182 after the first dose ] [ Designated as safety issue: No ]

    Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.


  • Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. [ Time Frame: On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups ] [ Designated as safety issue: No ]

    Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.


  • Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. [ Time Frame: At Day 182 from Day 0 ] [ Designated as safety issue: No ]

    Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.


  • Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. [ Time Frame: On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups ] [ Designated as safety issue: No ]

    Titers were expressed as geometric mean titers (GMTs).

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.


  • Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. [ Time Frame: At Day 182 after dose 1 vaccination ] [ Designated as safety issue: No ]

    Titers were expressed as geometric mean titers (GMTs).

    Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.



Enrollment: 611
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flulaval/placebo/unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Biological: GSK2340273A
Two intramuscular injections
Biological: Seasonal trivalent influenza vaccine (TIV)
Single intramuscular injection
Biological: Saline placebo
Single intramuscular injection
Experimental: Flulaval/placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Biological: GSK2340274A
Two intramuscular injections
Biological: Seasonal trivalent influenza vaccine (TIV)
Single intramuscular injection
Biological: Saline placebo
Single intramuscular injection
Experimental: Flulaval/unadjuvanted Arepanrix/placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Biological: GSK2340273A
Two intramuscular injections
Biological: Seasonal trivalent influenza vaccine (TIV)
Single intramuscular injection
Biological: Saline placebo
Single intramuscular injection
Experimental: Flulaval/Arepanrix/placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Biological: GSK2340274A
Two intramuscular injections
Biological: Seasonal trivalent influenza vaccine (TIV)
Single intramuscular injection
Biological: Saline placebo
Single intramuscular injection
Experimental: Unadjuvanted Arepanrix/placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Biological: GSK2340273A
Two intramuscular injections
Biological: Seasonal trivalent influenza vaccine (TIV)
Single intramuscular injection
Biological: Saline placebo
Single intramuscular injection
Experimental: Arepanrix/placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Biological: GSK2340274A
Two intramuscular injections
Biological: Seasonal trivalent influenza vaccine (TIV)
Single intramuscular injection
Biological: Saline placebo
Single intramuscular injection

Detailed Description:

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Male or female adults, 19-40 years of age at the time of the first vaccination.
  • Safety laboratory tests results within the parameters specified in the protocol.
  • Satisfactory baseline medical assessment by physical examination.
  • 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.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • 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 first 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 H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
  • Prior receipt at any time of any seasonal influenza vaccine.
  • Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 63 phlebotomy.
  • Administration of any licensed vaccine within 4 weeks before the first study vaccine dose.
  • Use of any investigational or non-registered product 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 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 three 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.
  • Presence of a temperature >= 38.0ºC (>=100.4ºF), 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.
  • 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 seasonal influenza vaccine.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin 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: NCT00985673

Locations
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Fort Worth, Texas, United States, 76135
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2K 4L5
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 4J6
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Langley J et al. Safety and immunogenicity of a monovalent H1N1 2009 vaccine with or without AS03A adjuvant when co-administered or sequentially administered with a seasonal influenza vaccine in adults 19 to 40 years of age. Abstract presented at the International Symposium on Respiratory Viral Infections - XIII (ISRVI). Rome, Italy, 13-16 March 2011.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00985673     History of Changes
Other Study ID Numbers: 113536
Study First Received: September 24, 2009
Results First Received: December 21, 2011
Last Updated: June 14, 2012
Health Authority: Canada: Biologics and Genetic Therapies Directorate (BGTD)
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GSK Bio's influenza vaccine GSK2340274A
influenza infection
GSK Bio's influenza vaccine GSK2340273A

Additional relevant MeSH terms:
Infection
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014