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A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03275389
Recruitment Status : Completed
First Posted : September 7, 2017
Results First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE August 29, 2017
First Posted Date  ICMJE September 7, 2017
Results First Submitted Date  ICMJE March 16, 2021
Results First Posted Date  ICMJE May 7, 2021
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE September 8, 2017
Actual Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2021)
  • Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration [ Time Frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose ]
    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
  • Number of Subjects With Solicited Local AEs After Second Dose Administration [ Time Frame: During the 7-day (Days 1-7) follow-up period after second vaccine dose ]
    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
  • Number of Subjects With Solicited Local AEs After Booster Dose Administration [ Time Frame: During the 7-day (Days 1-7) follow-up period after booster vaccine dose ]
    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 mm of injection site.
  • Number of Subjects With Solicited General AEs After First Dose Administration [ Time Frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose ]
    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
  • Number of Subjects With Solicited General AEs After Second Dose Administration [ Time Frame: During the 7-day (Days 1-7) follow-up period after second vaccine dose ]
    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
  • Number of Subjects With Solicited General AEs After Booster Dose Administration [ Time Frame: During the 7-day (Days 1-7) follow-up period after booster vaccine dose ]
    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
  • Number of Subjects With Any Unsolicited AEs Post-vaccination Period [ Time Frame: During the 28-day (Days 1-28) follow-up period accross doses ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination
  • Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading [ Time Frame: At Day 8 ]
    Hematological parameters assessed are: Eosinophils increase [EOSi], hemoglobin decrease [HEMd] , lymphocytes decrease [LYMd], Neutrophils decrease [NEUd], platelets decrease [PLTCd], white blood cells decrease [WBCd], WBC increase [WBCi]. Biochemical parameters assessed are: alanine aminotransferase increase [ALTi], aspartate aminotransferase increase [ASTi], blood urea nitrogen [BUN], creatinine [CRE].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALT-Grade 0-Grade 1".
  • Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading [ Time Frame: From Day 8 to Day 29 ]
    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
  • Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading [ Time Frame: From Day 8 to Day 85 ]
    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
  • Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading [ Time Frame: From Day 8 to Month 14 + 28 days ]
    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
  • Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading [ Time Frame: From Day 8 to Month 26 ]
    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
  • Number of Subjects With Any Medically-attended Adverse Events (MAEs) [ Time Frame: During the entire study period (from Day 1 up to Month 26) ]
    MAEs are defined as events for which the subject receives medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
  • Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) [ Time Frame: During the entire study period (from Day 1 up to Month 26) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
  • Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (from Day 1 up to Month 26) ]
    SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 1 [ Time Frame: At Day 1 ]
    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 ELISA.Unit per milliliter (EL.U/mL).
  • Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 29 [ Time Frame: At Day 29 ]
    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
  • Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 85 [ Time Frame: At Day 85 ]
    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
  • Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1 [ Time Frame: At Day 1 ]
    Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
  • Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29 [ Time Frame: At Day 29 ]
    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
  • Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85 [ Time Frame: At Day 85 ]
    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
  • Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 1 [ Time Frame: At Day 1 ]
    Anti-H1 stalk immune response measured by MN are expressed in 1/DILUTION (DIL). The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
  • Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 29 [ Time Frame: At Day 29 ]
    Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
  • Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 85 [ Time Frame: At Day 85 ]
    Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
  • Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1 [ Time Frame: At Day 1 ]
    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
  • Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29 [ Time Frame: At Day 29 ]
    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
  • Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85 [ Time Frame: At Day 85 ]
    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
  • Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29 [ Time Frame: At Day 29, compared to pre-vaccination at Day 1 ]
    Percentage of subjects with an equal or greater than (≥) 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
  • Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85 [ Time Frame: At Day 85, compared to pre-vaccination at Day 1 ]
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
  • Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29 [ Time Frame: At Day 29, compared to pre-vaccination at Day 1 ]
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
  • Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85 [ Time Frame: At Day 85, compared to pre-vaccination at Day 1 ]
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
  • Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29 [ Time Frame: At Day 29, compared to pre-vaccination at Day 1 ]
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
  • Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85 [ Time Frame: At Day 85, compared to pre-vaccination at Day 1 ]
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
  • Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29 [ Time Frame: At Day 29, compared to pre-vaccination at Day 1 ]
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
  • Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85 [ Time Frame: At Day 85, compared to pre-vaccination at Day 1 ]
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
  • Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29 [ Time Frame: At Day 29, compared to pre-vaccination at Day 1 ]
    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
  • MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85 [ Time Frame: At Day 85, compared to pre-vaccination at Day 1 ]
    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
  • MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29 [ Time Frame: At Day 29, compared to pre-vaccination at Day 1 ]
    MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
  • MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85 [ Time Frame: At Day 85, compared to pre-vaccination at Day 1 ]
    MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • Occurrence of solicited local and general adverse events (AEs) [ Time Frame: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after each vaccine dose ]
    Any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of well defined AEs is actively solicited from the study participant during a specified post-vaccination follow-up period.
  • Occurrence of unsolicited AEs [ Time Frame: During the 28-day follow-up period (i.e. on the day of vaccination and 27 subsequent days) after each vaccine dose. ]
    Any untoward medical occurrence in a patient or clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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.
  • Occurrence of hematological and biochemical laboratory abnormalities after each vaccination [ Time Frame: At each protocol defined visit after Day 1 until Visit 12 (i.e. at Days 8, 29, 57, 64 and 85 and Month 8, Month 14, Month 14 + 7 days, Month 14 +28 days, Month 20 and Month 26). ]
    Any hematological or biochemical laboratory abnormality at each visit subsequent to Day 1
  • Occurrence of Medically Attended Events (MAEs) [ Time Frame: Throughout the entire study period (Day 1 to Month 26) ]
    MAEs are adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
  • Occurrence of Potential Immune-Mediated Diseases (pIMDs) [ Time Frame: Throughout the entire study period (Day 1 to Month 26) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Throughout the entire study period (Day 1 to Month 26) ]
    A SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
  • Evaluation of levels of anti-H1 stalk antibody titers by ELISA [ Time Frame: At pre-vaccination (Day 1) and at 28 days post Dose 1 and Dose 2 (i.e. at Day 29 and Day 85). ]
    The following aggregate variables will be calculated for the above parameters with 95% CI
    • Seropositivity rates and geometric mean titers (GMTs).
  • Evaluation of levels of anti-H1 stalk antibody titers by MN assay [ Time Frame: At pre-vaccination (Day 1) and at 28 days post Dose 1 and Dose 2 (i.e. at Day 29 and Day 85). ]
    The following aggregate variables will be calculated for the above parameters with 95% CI
    • Seropositivity rates and geometric mean titers (GMTs).
  • Evaluation of levels of anti-H1 stalk antibody titers by ELISA [ Time Frame: From Day 1 to Days 29 and 85. ]
    The following aggregate variables will be calculated for the above parameters with 95% CI:
    • Percentage of subjects with a ≥ 4-fold increase.
  • Evaluation of levels of anti-H1 stalk antibody titers by ELISA [ Time Frame: From Day 1 to Days 29 and 85. ]
    The following aggregate variables will be calculated for the above parameters with 95% CI:
    • Percentage of subjects with a ≥ 10-fold increase.
  • Evaluation of levels of anti-H1 stalk antibody titers by ELISA [ Time Frame: From Day 1 to Days 29 and 85. ]
    Mean geometric increase (MGI) will be calculated for the above parameters with 95% CI
  • Evaluation of levels of anti-H1 stalk antibody titers by MN assay [ Time Frame: From Day 1 to Days 29 and 85. ]
    The following aggregate variables will be calculated for the above parameters with 95% CI:
    • Percentage of subjects with a ≥ 4-fold increase.
  • Evaluation of levels of anti-H1 stalk antibody titers by MN assay [ Time Frame: From Day 1 to Days 29 and 85. ]
    The following aggregate variables will be calculated for the above parameters with 95% CI: Percentage of subjects with a ≥ 10-fold increase.
  • Evaluation of levels of anti-H1 stalk antibody titers by MN assay [ Time Frame: From Day 1 to Days 29 and 85. ]
    Mean geometric increase (MGI) will be calculated for the above parameters with 95% CI
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2021)
  • Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA [ Time Frame: 28 days post priming dose(s) i.e. at Day 29 for 1 priming dose groups and at Day 85 for 2 priming doses groups ]
    The adjusted GMCs are presented to evaluate the adjuvant effect post-dose 1 and post-dose 2.
  • Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26 [ Time Frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
  • Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26 [ Time Frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
  • Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26. [ Time Frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1 ]
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
  • Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26. [ Time Frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1 ]
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
  • MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26 [ Time Frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1 ]
    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
  • Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA [ Time Frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26 ]
    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).
  • Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA [ Time Frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26 ]
    Anti-H2 and anti-H18 immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).
  • Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA [ Time Frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1 ]
    Percentage of subjects with a ≥ 4-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .
  • Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA [ Time Frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1 ]
    Percentage of subjects with a ≥ 10-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .
  • MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA [ Time Frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1 ]
    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1.
  • Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay [ Time Frame: At Days 1, 29 and 85 ]
    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL
  • Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay [ Time Frame: At Days 1, 29 and 85 ]
    Anti-H1N1 swine influenza and anti-IIV4-H1N1 immune response measured by MN assay. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: cut-off = 20 1/DIL.
  • Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay [ Time Frame: At Day 29 and Day 85, compared to Day 1 ]
    Percentage of subjects with a ≥ 4-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.
  • Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay [ Time Frame: At Day 29 and Day 85, compared to Day 1 ]
    Percentage of subjects with a ≥ 10-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.
  • MGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay [ Time Frame: At Day 29 and at Day 85, compared to Day 1 ]
    MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • Evaluation of adjuvant effect on the anti-stalk immune response in terms of Geometric Mean Titer (GMT) ratio for anti-stalk ELISA titer SUIV+AS03 or AS01/SUIV non-adjuvanted [ Time Frame: At 28 days post vaccination (i.e. at Day 29 to evaluate the adjuvant effect post-dose 1 and at Day 85 to evaluate the adjuvant effect post-dose 2). ]
    GMT ratio for anti-stalk ELISA titer SUIV+AS03 or AS01/SUIV non-adjuvanted
  • Evaluation of levels of anti-H1 stalk antibody titers by ELISA post-each vaccination [ Time Frame: At the protocol defined blood sampling timepoints for antibody determination (i.e. at Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26). ]
    Seropositivity rates and GMTs will be calculated for the mentioned parameters with 95% CI
  • Evaluation of levels of anti-H1 stalk antibody titers by ELISA post-each vaccination [ Time Frame: From Day 1 to Day 29, Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI: - Percentage of subjects with a ≥ 4-fold increase in antibody titers.
  • Evaluation of levels of anti-H1 stalk antibody titers by ELISA post-each vaccination [ Time Frame: From Day 1 to Day 29, Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI:
    • Percentage of subjects with a ≥ 10-fold increase in antibody titers.
  • Evaluation of levels of anti-H1 stalk antibody titers by ELISA post-each vaccination [ Time Frame: From Day 1 to Day 29, Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    Mean Geometric Increase (MGI) will be calculated for the mentioned parameters with 95% CI.
  • Evaluation of levels of anti-H1 stalk antibody titers by MN assays post-each vaccination. [ Time Frame: At Days 1, 29, 85, Month 14, Month 14 + 28 days and Month 26. ]
    Seropositivity rates and GMTs will be calculated for the mentioned parameters with 95% CI
  • Evaluation of levels of anti-H1 stalk antibody titers by MN assay post-each vaccination. [ Time Frame: From Day 1 to Day 29, Day 85, Month 14, Month 14 + 28 days and Month 26 ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI: - Percentage of subjects with a ≥ 4-fold increase in antibody titers by MN assay.
  • Evaluation of levels of anti-H1 stalk antibody titers by MN assay post-each vaccination. [ Time Frame: From Day 1 to Day 29, Day 85, Month 14, Month 14 + 28 days and Month 26 ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI: - Percentage of subjects with a ≥ 10-fold increase in antibody titers by MN assay.
  • Evaluation of levels of anti-H1 stalk antibody titers by MN assay post-each vaccination. [ Time Frame: From Day 1 to Day 29, Day 85, Month 14, Month 14 + 28 days and Month 26 ]
    MGI will be calculated for the mentioned parameters with 95% CI
  • Evaluation of levels of anti-H2 and anti-H18 antibody titers by ELISA. [ Time Frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI: - Anti-H2 and anti-H18 seropositivity rates and GMTs.
  • Evaluation of levels of anti-H2 and anti-H18 antibody titers by ELISA. [ Time Frame: From Day 1 to Day 29, Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI: - Percentage of subjects with a ≥ 4-fold increase in anti-H2 and anti-H18 antibody titers.
  • Evaluation of levels of anti-H2 and anti-H18 antibody titers by ELISA. [ Time Frame: From Day 1 to Day 29, Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI:
    • Percentage of subjects with a ≥ 10-fold increase in anti-H2 and anti-H18 antibody titers.
  • Evaluation of levels of anti-H2 and anti-H18 antibody titers by ELISA. [ Time Frame: From Day 1 to Day 29, Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    MGI will be calculated for the mentioned parameters with 95% CI
  • Evaluation of levels of antibody titers by MN assays. [ Time Frame: At Days 1, 29, 85, Month 14, Month 14 + 28 days and Month 26. ]
    Seropositivity rates and GMTs will be calculated for the mentioned parameters with 95% CI for H5N8; H1N1 swine influenza and Quadrivalent inactivated influenza (IIV4) H1N1 vaccine strains.
  • Evaluation of levels of antibody titers by MN assays for H5N8; H1N1 swine influenza and IIV4 H1N1 vaccine strains. [ Time Frame: From Day 1 to Day 29, Day 85, Month 14, Month 14 + 28 days and Month 26. ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI:
    • Percentage of subjects with a ≥ 4-fold increase in antibody titers.
  • Evaluation of levels of antibody titers by MN assays for H5N8; H1N1 swine influenza and IIV4 H1N1 vaccine strains. [ Time Frame: From Day 1 to Day 29, Day 85, Month 14, Month 14 + 28 days and Month 26. ]
    The following aggregate variables will be calculated for the mentioned parameters with 95% CI:
    • Percentage of subjects with a ≥ 10-fold increase in antibody titers.
  • Evaluation of levels of antibody titers by MN assays for H5N8; H1N1 swine influenza and IIV4 H1N1 vaccine strains. [ Time Frame: From Day 1 to Day 29, Day 85, Month 14, Month 14 + 28 days and Month 26. ]
    MGI will be calculated for the mentioned parameters with 95% CI
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
Official Title  ICMJE Reactogenicity, Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults
Brief Summary The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s) followed by a booster dose one year later.
Detailed Description

Current seasonal influenza vaccines show good efficacy when they are well-matched with the circulating virus strains.

However, influenza viruses constantly change their surface glycoproteins that are the targets of most immune responses, allowing them to escape pre-existing immunity, a process called antigenic drift. Therefore, seasonal influenza vaccines have to be reformulated and re-administered on an annual basis. In addition, novel viruses can appear at irregular intervals and cause influenza virus pandemics that can claim millions of lives.

GSK Biologicals is now developing a new influenza vaccine that contains modified inactivated influenza viruses. The purpose of this approach is to elicit an immune response that would protect against all current and future circulating influenza strains without having to administer the vaccine each year.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

The site staff will work in an observer-blind manner. As the vaccines appearance and preparation are different, two teams of study personnel will be set up:

  • A team of unblinded personnel (responsible for the reception, preparation and administration of the vaccines).
  • A team of blinded personnel (responsible for the clinical safety evaluation of the subjects).
Primary Purpose: Prevention
Condition  ICMJE Influenza, Human
Intervention  ICMJE
  • Biological: D-SUIV cH8/1N1+AS03
    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 03 (AS03) was administered intramuscularly (IM) in the deltoid region of non-dominant arm.
  • Biological: D-SUIV cH5/1N1+AS03
    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.
  • Biological: D-SUIV cH11/1N1+AS03
    1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.
  • Biological: D-SUIV cH8/1N1+AS01
    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
  • Biological: D-SUIV cH5/1N1+AS01
    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
  • Biological: D-SUIV cH11/1N1+AS01
    1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
  • Biological: D-SUIV cH8/1N1
    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
  • Biological: D-SUIV cH5/1N1
    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
  • Biological: D-SUIV cH11/1N1
    1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
  • Biological: Placebo
    1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.
  • Biological: Fluarix Quadrivalent
    1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.
Study Arms  ICMJE
  • Experimental: D-SUIV Adjuvanted Group 1
    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1+AS03
    • Biological: D-SUIV cH5/1N1+AS03
    • Biological: Placebo
  • Experimental: D-SUIV Adjuvanted Group 2
    Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1+AS03
    • Biological: D-SUIV cH5/1N1+AS03
    • Biological: Placebo
  • Experimental: D-SUIV Adjuvanted Group 3
    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1+AS03
    • Biological: D-SUIV cH5/1N1+AS03
    • Biological: D-SUIV cH11/1N1+AS03
  • Experimental: D-SUIV Adjuvanted Group 4
    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1+AS01
    • Biological: D-SUIV cH5/1N1+AS01
    • Biological: Placebo
  • Experimental: D-SUIV Adjuvanted Group 5
    Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1+AS01
    • Biological: D-SUIV cH5/1N1+AS01
    • Biological: Placebo
  • Experimental: D-SUIV Adjuvanted Group 6
    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1+AS01
    • Biological: D-SUIV cH5/1N1+AS01
    • Biological: D-SUIV cH11/1N1+AS01
  • Experimental: D-SUIV Unadjuvanted Group 1
    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1
    • Biological: D-SUIV cH5/1N1
    • Biological: Placebo
  • Experimental: D-SUIV Unadjuvanted Group 2
    Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1
    • Biological: D-SUIV cH5/1N1
    • Biological: Placebo
  • Experimental: D-SUIV Unadjuvanted Group 3
    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: D-SUIV cH8/1N1
    • Biological: D-SUIV cH5/1N1
    • Biological: D-SUIV cH11/1N1
  • Active Comparator: IIV4 Group
    Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Interventions:
    • Biological: Placebo
    • Biological: Fluarix Quadrivalent
Publications * Folschweiller N, Vanden Abeele C, Chu L, Van Damme P, Garcia-Sastre A, Krammer F, Nachbagauer R, Palese P, Solorzano A, Bi D, David MP, Friel D, Innis BL, Koch J, Mallett CP, Rouxel RN, Salaun B, Vantomme V, Verheust C, Struyf F. Reactogenicity, safety, and immunogenicity of chimeric haemagglutinin influenza split-virion vaccines, adjuvanted with AS01 or AS03 or non-adjuvanted: a phase 1-2 randomised controlled trial. Lancet Infect Dis. 2022 Jul;22(7):1062-1075. doi: 10.1016/S1473-3099(22)00024-X. Epub 2022 Apr 21. Erratum In: Lancet Infect Dis. 2022 Jun;22(6):e159.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2020)
470
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2017)
450
Actual Study Completion Date  ICMJE March 26, 2020
Actual Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject prior to performance of any study specific procedure.
  • A male or female between, and including, 18 and 39 years of age at the time of the first vaccination.
  • Healthy subjects without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as established by medical history and clinical examination before first vaccination and laboratory screening tests (the latter being only applicable for subjects enrolled in Phase I).
  • Subjects with no history of influenza vaccination within 6 months prior to first study vaccination and who are willing to forego any influenza vaccination during the entire study period.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • Has practiced adequate contraception for 30 days prior to first 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 (last vaccination at Month 14).

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs within 6 months before first vaccination, or planned administration any time during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose up to the blood sampling at Day 85 and in the period starting 30 days before booster vaccination at Month 14 up to the blood sample at Month 14 + 28 days.
  • 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 vaccine/product.
  • Previous vaccination against influenza within the 6 months preceding the first vaccination at Visit 1 or planned use of such vaccines during the study period.
  • History of vaccination with a (pre)pandemic influenza vaccine other than an H1N1pdm09 vaccine or history of laboratory-confirmed influenza infection other than seasonal or H1N1pdm09 influenza.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of or current autoimmune disease.
  • Subjects diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject's parent or sibling.
  • History of Guillain-Barré syndrome.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Hypersensitivity to latex.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
    • For subjects with acute disease and/or fever at the time of enrolment, Visit 1 may be re-scheduled within the allowed time-window.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period.
  • Blood donation within 30 days before the first study blood sampling or planned blood donation within 30 days before and up to 30 days after any study blood sampling.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Additional criterion applicable for Phase I subjects:

  • Hematological and/or biochemical parameters outside the laboratory normal ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
  • Liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) outside of the normal laboratory ranges.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03275389
Other Study ID Numbers  ICMJE 207543
2017-001584-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com
Current Responsible Party GlaxoSmithKline
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2021

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