Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    GSK | Interventional Studies | Influenza universal
Previous Study | Return to List | Next Study

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
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: D-SUIV Formulation 1 Biological: D-SUIV Formulation 2 Biological: D-SUIV Formulation 3 Biological: D-SUIV Formulation 4 Biological: D-SUIV Formulation 5 Biological: D-SUIV Formulation 6 Biological: D-SUIV Formulation 7 Biological: D-SUIV Formulation 8 Biological: D-SUIV Formulation 9 Biological: Placebo Biological: FLU-D-QIV Phase 1

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.

Layout table for study information
Study Type : Interventional
Actual Enrollment : 470 participants
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
Official Title: Reactogenicity, Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults
Actual Study Start Date : September 8, 2017
Actual Primary Completion Date : March 26, 2020
Actual Study Completion Date : March 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: D-SUIV Adjuvanted Group 1
Subjects will receive one dose of D-SUIV Formulation 1 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 2 at Month 14
Biological: D-SUIV Formulation 1
1 Primary dose or 1 Booster dose will be administered intramuscularly (IM) in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 2
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Adjuvanted Group 2
Subjects will receive one dose of D-SUIV Formulation 2 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 1 at Month 14
Biological: D-SUIV Formulation 1
1 Primary dose or 1 Booster dose will be administered intramuscularly (IM) in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 2
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Adjuvanted Group 3
Subjects will receive one dose of D-SUIV Formulation 1 at Day 1, one dose of D-SUIV Formulation 2 at Day 57 and one booster dose of D-SUIV Formulation 3 at Month 14
Biological: D-SUIV Formulation 1
1 Primary dose or 1 Booster dose will be administered intramuscularly (IM) in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 2
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 3
1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Experimental: D-SUIV Adjuvanted Group 4
Subjects will receive one dose of D-SUIV Formulation 4 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 5 at Month 14
Biological: D-SUIV Formulation 4
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 5
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Adjuvanted Group 5
Subjects will receive one dose of D-SUIV Formulation 5 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 4 at Month 14
Biological: D-SUIV Formulation 4
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 5
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Adjuvanted Group 6
Subjects will receive one dose of D-SUIV Formulation 4 at Day 1, one dose D-SUIV Formulation 5 at Day 57 and one booster dose of D-SUIV Formulation 6 at Month 14
Biological: D-SUIV Formulation 4
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 5
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 6
1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Unadjuvanted Group 1
Subjects will receive one dose of D-SUIV Formulation 7 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 8 at Month 14
Biological: D-SUIV Formulation 7
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 8
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Unadjuvanted Group 2
Subjects will receive one dose of D-SUIV Formulation 8 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 7 at Month 14
Biological: D-SUIV Formulation 7
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 8
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Unadjuvanted Group 3
Subjects will receive one dose of D-SUIV Formulation 7 at Day 1, one dose D-SUIV Formulation 8 at Day 57 and one booster dose of D-SUIV Formulation 9 at Month 14
Biological: D-SUIV Formulation 7
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 8
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 9
1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Active Comparator: IIV4 Group
Subjects will receive one dose of Fluarix Quadrivalent at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent at Month 14
Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Biological: FLU-D-QIV
1 Primary dose and 1 Booster dose will be administered IM in the deltoid region of non-dominant arm
Other Name: Fluarix Quadrivalent




Primary Outcome Measures :
  1. Number of subjects with solicited local adverse events (AEs) after first dose administration [ Time Frame: During the 7-day (Days 0-6) follow-up period after first vaccine dose ]
    Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Any redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  2. Number of subjects with solicited local AEs after second dose administration [ Time Frame: During the 7-day (Days 0-6) follow-up period after second vaccine dose ]
    Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Any redness/swelling = redness/swelling spreading beyond 20 mm of injection site.

  3. Number of subjects with solicited local AEs after booster dose administration [ Time Frame: During the 7-day (Days 0-6) follow-up period after booster vaccine dose ]
    Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Any redness/swelling = redness/swelling spreading beyond 20 mm of injection site.

  4. Number of subjects with solicited general AEs after first dose administration [ Time Frame: During the 7-day (Days 0-6) follow-up period after first vaccine dose ]
    Assessed solicited general symptoms are fatigue, fever [defined as orally temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms, headache, myalgia, shivering and arthralgia. Any = occurrence of the symptom regardless of intensity grade.

  5. Number of subjects with solicited general AEs after second dose administration [ Time Frame: During the 7-day (Days 0-6) follow-up period after second vaccine dose ]
    Assessed solicited general symptoms are fatigue, fever [defined as orally temperature equal to or above 38.0 °C], gastrointestinal symptoms, headache, myalgia, shivering and arthralgia. Any = occurrence of the symptom regardless of intensity grade.

  6. Number of subjects with solicited general AEs after booster dose administration [ Time Frame: During the 7-day (Days 0-6) follow-up period after booster vaccine dose ]
    Assessed solicited general symptoms are fatigue, fever [defined as orally temperature equal to or above 38.0 °C], gastrointestinal symptoms, headache, myalgia, shivering and arthralgia. Any = occurrence of the symptom regardless of intensity grade.

  7. Number of subjects with any unsolicited AEs after first dose administration [ Time Frame: During the 28-day (Days 0-27) follow-up period after first vaccine dose ]
    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.

  8. Number of subjects with any unsolicited AEs after second dose administration [ Time Frame: During the 28-day (Days 0-27) follow-up period after second vaccine dose ]
    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.

  9. Number of subjects with any unsolicited AEs after booster dose administration [ Time Frame: During the 28-day (Days 0-27) follow-up period after booster vaccine dose ]
    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.

  10. Number of subjects with abnormal hematological and biochemical laboratory ranges at Day 8 [ Time Frame: At Day 8 ]
    Hematological parameters assessed are: red blood cells [RBC], white blood cells [WBC], differential count [DC], platelets count [PLTC], hemoglobin [HEM]. Biochemical parameters assessed are: alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], blood urea nitrogen [BUN] and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  11. Number of subjects with abnormal hematological and biochemical laboratory ranges at Day 29 [ Time Frame: At Day 29 ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  12. Number of subjects with abnormal hematological and biochemical laboratory ranges at Day 57 [ Time Frame: At Day 57 ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  13. Number of subjects with abnormal hematological and biochemical laboratory ranges at Day 64 [ Time Frame: At Day 64 ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  14. Number of subjects with abnormal hematological and biochemical laboratory ranges at Day 85 [ Time Frame: At Day 85 ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  15. Number of subjects with abnormal hematological and biochemical laboratory ranges at Month 8 [ Time Frame: At Month 8 ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  16. Number of subjects with abnormal hematological and biochemical laboratory ranges at Month 14 [ Time Frame: At Month 14 ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  17. Number of subjects with abnormal hematological and biochemical laboratory ranges at Month 14 + 7 days [ Time Frame: At Month 14 + 7 days ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  18. Number of subjects with abnormal hematological and biochemical laboratory ranges at Month 14 + 28 days [ Time Frame: At Month 14 + 28 days ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  19. Number of subjects with abnormal hematological and biochemical laboratory ranges at Month 20 [ Time Frame: At Month 20 ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  20. Number of subjects with abnormal hematological and biochemical laboratory ranges at Month 26 [ Time Frame: At Month 26 ]
    Hematological parameters assessed are: RBC, WBC, DC, PLTC, HEM. Biochemical parameters assessed are: ALT, AST, CRE, BUN and BUN-to-creatinine ratio. Laboratory ranges assessed are: below, within and above.

  21. 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.

  22. 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.

  23. 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.

  24. 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).

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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..

  36. Percentage of subjects with an equal or greater than (≥) 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 a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

  37. 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.

  38. 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.

  39. 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.

  40. 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 assay.

  41. 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.

  42. Percentage of subjects with a ≥ 10-fold increase of anti-H1stalk 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.

  43. 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.

  44. 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

  45. MGI for anti-H1 stalk antibody concentrations 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

  46. 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.

  47. 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.


Secondary Outcome Measures :
  1. Adjusted GMCs for anti-H1 HA stalk antibody, anti-H2 and anti-H18 antibody, measured by ELISA. [ 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. ]
    The adjusted GMCs are presented to evaluate the adjuvant effect post-dose 1 and post-dose 2.

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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).

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. Titers for anti-H1N1 swine influenza and anti-IIV4-H1N1 antibodies 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.

  13. 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

  14. 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.

  15. 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 at 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.

  16. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275389


Locations
Layout table for location information
United States, Florida
GSK Investigational Site
South Miami, Florida, United States, 33143
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14609
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03275389    
Other Study ID Numbers: 207543
2017-001584-20 ( EudraCT Number )
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints 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: http://clinicalstudydatarequest.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Safety
Healthy adults
Immunogenicity
Supra-seasonal universal influenza vaccines - inactivated (SUIVs)
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases