Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age
An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
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Nova Scotia
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Truro, Nova Scotia, Canada, B2N 1L2
- GSK Investigational Site
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Ontario
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Woodstock, Ontario, Canada, N4S 5P5
- GSK Investigational Site
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Quebec
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Sherbrooke, Quebec, Canada, J1H 2G2
- GSK Investigational Site
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Florida
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Jacksonville, Florida, United States, 32216
- GSK Investigational Site
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Georgia
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Stockbridge, Georgia, United States, 30281
- GSK Investigational Site
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Idaho
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Boise, Idaho, United States, 83642
- GSK Investigational Site
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Pennsylvania
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Erie, Pennsylvania, United States, 16506
- GSK Investigational Site
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Washington
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Seattle, Washington, United States, 98105
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female adults who are 18 to 64 years of age (inclusive) at the time of first study vaccination.
- Written informed consent obtained from subject.
- Subjects who the investigator believes can and will comply with the requirements of the protocol .
- Healthy subjects as established by medical history and physical examination.
- Access to a consistent means of telephone contact.
- For subjects who undergo a screening visit: results of all safety laboratory tests obtained at the screening visit must be within reference ranges. Results of any repeat testing cannot be used to qualify a subject for enrolment.
- Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if they
- have practiced adequate contraception for 30 days prior to vaccination, and
- have a negative pregnancy test on the day of vaccination, and
- agree to continue to practice adequate contraception until 2 months after the last dose administered.
Exclusion Criteria:
- Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence or evidence of substance abuse.
- Diagnosed with cancer, or treatment for cancer within three years.
- Diagnosed with excessive daytime sleepiness, or narcolepsy; or history of narcolepsy in a subject's parent, sibling or child.
- Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/ placebo dose.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
- Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/placebo.
- Planned administration of any vaccine other than the study vaccine/placebo before blood sampling at the Day 42 visit.
- Previous administration of any H7 vaccine or physician-confirmed H7 disease.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.
- Receipt of any immunoglobulins and/or any blood products within 90 days before the first dose of study vaccine/placebo, or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first dose of study vaccine/placebo.
- Lactating or nursing women.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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EXPERIMENTAL: Formulation 1 Group
Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 1 at a 21 day interval
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One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21
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EXPERIMENTAL: Formulation 2 Group
Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 2 at a 21 day interval
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One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21
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EXPERIMENTAL: Formulation 3 Group
Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 3 at a 21 day interval
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One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21
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EXPERIMENTAL: Formulation 4 Group
Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 4 at a 21 day interval
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One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21
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EXPERIMENTAL: Formulation 5 Group
Subjects in this group will receive two doses of GSK3206640A H7N9 vaccine formulation 5 at a 21 day interval
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One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21
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PLACEBO_COMPARATOR: Placebo Group
Subjects in this group will receive two doses of placebo at a 21 day interval
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One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Occurrence of each solicited local symptom
Time Frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
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During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
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Occurrence of each solicited general symptom
Time Frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
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During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
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Occurrence of unsolicited adverse events
Time Frame: 21 days after each dose
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21 days after each dose
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Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
Time Frame: At Day 42
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The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)
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At Day 42
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Occurrence of clinical safety laboratory abnormalities reported for samples
Time Frame: At Day 0 visit
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At Day 0 visit
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Occurrence of clinical safety laboratory abnormalities reported for samples
Time Frame: At Day 7 visit
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At Day 7 visit
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Occurrence of clinical safety laboratory abnormalities reported for samples
Time Frame: At Day 21 visit
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At Day 21 visit
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Occurrence of clinical safety laboratory abnormalities reported for samples
Time Frame: At Day 28 visit
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At Day 28 visit
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Occurrence of clinical safety laboratory abnormalities reported for samples
Time Frame: At Day 42 visit
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At Day 42 visit
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Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)
Time Frame: From Day 0 until the Day 42
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From Day 0 until the Day 42
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
Time Frame: At Day 42
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The following aggregate variables will be calculated for each adjuvanted (GSK3206641A) vaccine group which successfully meets CBER and CHMP criteria, and for the unadjuvanted (GSK3206640A) plain antigen vaccine group: • Geometric mean reciprocal serum HI antibody titers (GMTs); • SCR
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At Day 42
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Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
Time Frame: At Day 42
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The following aggregate variables will be calculated for the unadjuvanted plain antigen vaccine group: • SCR; • SPR; • MGI
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At Day 42
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Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers
Time Frame: GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 (Placebo group only) and Months 6 and 12; SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12
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The following aggregate variables will be calculated for each study group: • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI
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GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 (Placebo group only) and Months 6 and 12; SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12
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Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum
Time Frame: GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 and Months 6 and 12
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The following aggregate variables will be calculated for each study group by age stratum (18-40 years; 41-64 years): • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI
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GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 and Months 6 and 12
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Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers
Time Frame: GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6; VRR at Days 21, 42 and Month 6
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The following parameters will be calculated for a subset of subjects in each study group: • GMTs; • Seropositivity rates; • Vaccine response rate (VRR)
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GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6; VRR at Days 21, 42 and Month 6
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Occurrence of MAEs, pIMDs and SAEs
Time Frame: Until the Month 12 visit
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Until the Month 12 visit
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Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 201072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Informed Consent Form
Information identifier: 201072Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 201072Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 201072Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 201072Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 201072Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 201072Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 201072Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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