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

NCT03275389 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2075432017-001584-20
• Study Type: interventional
• Target: 470
• Locations: 2 countries
• Sites: 6

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.

Conditions

Influenza, Human

Keywords

Safety; Healthy adults; Immunogenicity; Supra-seasonal universal influenza vaccines - inactivated (SUIVs)

Outcome Measures

Primary Outcomes (39)

• Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration

  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.

  During the 7-day (Days 1-7) follow-up period after first vaccine dose

• Number of Subjects With Solicited Local AEs After Second Dose Administration

  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.

  During the 7-day (Days 1-7) follow-up period after second vaccine dose

• Number of Subjects With Solicited Local AEs After Booster Dose Administration

  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.

  During the 7-day (Days 1-7) follow-up period after booster vaccine dose

• Number of Subjects With Solicited General AEs After First Dose Administration

  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

  During the 7-day (Days 1-7) follow-up period after first vaccine dose

• Number of Subjects With Solicited General AEs After Second Dose Administration

  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

  During the 7-day (Days 1-7) follow-up period after second vaccine dose

• Number of Subjects With Solicited General AEs After Booster Dose Administration

  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.

  During the 7-day (Days 1-7) follow-up period after booster vaccine dose

• Number of Subjects With Any Unsolicited AEs Post-vaccination Period

  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

  During the 28-day (Days 1-28) follow-up period accross doses

• Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading

  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".

  At Day 8

• Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading

  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.

  From Day 8 to Day 29

• Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading

  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.

  From Day 8 to Day 85

• Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading

  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.

  From Day 8 to Month 14 + 28 days

• Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading

  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.

  From Day 8 to Month 26

• Number of Subjects With Any Medically-attended Adverse Events (MAEs)

  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.

  During the entire study period (from Day 1 up to Month 26)

• Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)

  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.

  During the entire study period (from Day 1 up to Month 26)

• Number of Subjects With Serious Adverse Events (SAEs).

  SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  During the entire study period (from Day 1 up to Month 26)

• Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- 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).

  At Day 1

• Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- 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.

  At Day 29

• Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- 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.

  At Day 85

• Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1

  Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

  At Day 1

• Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29

  Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

  At Day 29

• Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85

  Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

  At Day 85

• Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - 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.

  At Day 1

• Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - 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.

  At Day 29

• Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - 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.

  At Day 85

• Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1

  Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

  At Day 1

• Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29

  Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

  At Day 29

• Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85

  Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

  At Day 85

• Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

  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.

  At Day 29, compared to pre-vaccination at Day 1

• Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

  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.

  At Day 85, compared to pre-vaccination at Day 1

• Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29

  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.

  At Day 29, compared to pre-vaccination at Day 1

• Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85

  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.

  At Day 85, compared to pre-vaccination at Day 1

• Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

  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.

  At Day 29, compared to pre-vaccination at Day 1

• Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

  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.

  At Day 85, compared to pre-vaccination at Day 1

• Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29

  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.

  At Day 29, compared to pre-vaccination at Day 1

• Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85

  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.

  At Day 85, compared to pre-vaccination at Day 1

• Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

  MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

  At Day 29, compared to pre-vaccination at Day 1

• MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

  MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

  At Day 85, compared to pre-vaccination at Day 1

• MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29

  MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

  At Day 29, compared to pre-vaccination at Day 1

• MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85

  MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

  At Day 85, compared to pre-vaccination at Day 1

Secondary Outcomes (16)

• Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA

  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

• Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26

  At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.

• Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26

  At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.

• Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.

  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, Measured by ELISA - Month 8 to 26.

  At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1

Study Arms (10)

D-SUIV Adjuvanted Group 1

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1+AS03; Biological: D-SUIV cH5/1N1+AS03; Biological: Placebo

D-SUIV Adjuvanted Group 2

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1+AS03; Biological: D-SUIV cH5/1N1+AS03; Biological: Placebo

D-SUIV Adjuvanted Group 3

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1+AS03; Biological: D-SUIV cH5/1N1+AS03; Biological: D-SUIV cH11/1N1+AS03

D-SUIV Adjuvanted Group 4

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1+AS01; Biological: D-SUIV cH5/1N1+AS01; Biological: Placebo

D-SUIV Adjuvanted Group 5

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1+AS01; Biological: D-SUIV cH5/1N1+AS01; Biological: Placebo

D-SUIV Adjuvanted Group 6

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1+AS01; Biological: D-SUIV cH5/1N1+AS01; Biological: D-SUIV cH11/1N1+AS01

D-SUIV Unadjuvanted Group 1

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1; Biological: D-SUIV cH5/1N1; Biological: Placebo

D-SUIV Unadjuvanted Group 2

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1; Biological: D-SUIV cH5/1N1; Biological: Placebo

D-SUIV Unadjuvanted Group 3

EXPERIMENTAL

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.

Biological: D-SUIV cH8/1N1; Biological: D-SUIV cH5/1N1; Biological: D-SUIV cH11/1N1

IIV4 Group

ACTIVE COMPARATOR

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.

Biological: Placebo; Biological: Fluarix Quadrivalent

Interventions

D-SUIV cH8/1N1+AS03 BIOLOGICAL

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.

D-SUIV Adjuvanted Group 1; D-SUIV Adjuvanted Group 2; D-SUIV Adjuvanted Group 3

D-SUIV cH5/1N1+AS03 BIOLOGICAL

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.

D-SUIV Adjuvanted Group 1; D-SUIV Adjuvanted Group 2; D-SUIV Adjuvanted Group 3

D-SUIV cH11/1N1+AS03 BIOLOGICAL

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.

D-SUIV Adjuvanted Group 3

D-SUIV cH8/1N1+AS01 BIOLOGICAL

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.

D-SUIV Adjuvanted Group 4; D-SUIV Adjuvanted Group 5; D-SUIV Adjuvanted Group 6

D-SUIV cH5/1N1+AS01 BIOLOGICAL

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.

D-SUIV Adjuvanted Group 4; D-SUIV Adjuvanted Group 5; D-SUIV Adjuvanted Group 6

D-SUIV cH11/1N1+AS01 BIOLOGICAL

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.

D-SUIV Adjuvanted Group 6

D-SUIV cH8/1N1 BIOLOGICAL

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.

D-SUIV Unadjuvanted Group 1; D-SUIV Unadjuvanted Group 2; D-SUIV Unadjuvanted Group 3

D-SUIV cH5/1N1 BIOLOGICAL

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.

D-SUIV Unadjuvanted Group 1; D-SUIV Unadjuvanted Group 2; D-SUIV Unadjuvanted Group 3

D-SUIV cH11/1N1 BIOLOGICAL

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.

D-SUIV Unadjuvanted Group 3

Placebo BIOLOGICAL

1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.

D-SUIV Adjuvanted Group 1; D-SUIV Adjuvanted Group 2; D-SUIV Adjuvanted Group 4; D-SUIV Adjuvanted Group 5; D-SUIV Unadjuvanted Group 1; D-SUIV Unadjuvanted Group 2; IIV4 Group

Fluarix Quadrivalent BIOLOGICAL

1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.

IIV4 Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

South Miami, Florida, 33143, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23502, United States

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35461522 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 7, 2017
• Study Start: September 8, 2017
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: May 7, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

BE (1); US (5)