Influenza
Conditions
Keywords
H7N9, Influenza, Safety, Adults, Adjuvant, Immunogenicity
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.
Interventions
BIOLOGICALInvestigational H7N9 vaccine GSK3206641A
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
BIOLOGICALInvestigational H7N9 vaccine GSK3206640A
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
BIOLOGICALPlacebo
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
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs) | From Day 0 until the Day 42 | — |
| Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers | At Day 42 | The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI) |
| Occurrence of each solicited local symptom | During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination | — |
| Occurrence of each solicited general symptom | During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination | — |
| Occurrence of clinical safety laboratory abnormalities reported for samples | At Day 0 visit | — |
| Occurrence of unsolicited adverse events | 21 days after each dose | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers | 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 | The following aggregate variables will be calculated for each study group: • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI |
| Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum | 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 | 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 |
| Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers | GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6; VRR at Days 21, 42 and Month 6 | The following parameters will be calculated for a subset of subjects in each study group: • GMTs; • Seropositivity rates; • Vaccine response rate (VRR) |
| Occurrence of MAEs, pIMDs and SAEs | Until the Month 12 visit | — |
| Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers | At Day 42 | 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 |
Countries
Canada, United States
Outcome results
None listed