Healthy volunteers (active immunization for the prevention of disease caused by influenza virus)
Conditions
Interventions
Product Name: Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1, AS03 adjuvanted
Product Code: cH8/1N1 + AS03A-like
Pharmaceutical Form: Powder and solvent for emulsion f
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion 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. •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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 470 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. 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 dis-continue contraceptive precautions. •Any condition that puts the subject at risk for serious influenza-related complications, as identified by the Advisory Committee on Immunization Practices (note that only criteria applicable for the study population are listed below): -Chronic pulm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the reactogenicity and safety of each vaccine dose throughout the entire study period, in all study groups. To describe the anti-H1 stalk humoral immune response 28 days after each priming dose (1 or 2 dose(s)) in all study groups.;Secondary Objective: To evaluate the adjuvant effect of AS03 and AS01 on the humoral immune response after 1 and 2 priming dose(s) of investigational SUIVs when compared to the non-adjuvanted formulations. To describe the persistence of the anti-H1 stalk humoral immune response after each priming dose (1 or 2 dose(s)) in all study groups up to Month 14. To describe the humoral immune response after a booster dose at Month 14. To describe the breadth of the humoral immune response after each vaccination in all study groups. To describe the effect of the chimeric HA vaccination-sequence on the humoral immune response.;Primary end point(s): 1. Number of subjects with solicited local AEs after first dose administration 2. Number of subjects with solicited local AEs after second dose administration 3. Number of subjects with solicited local AEs after booster dose administration 4. Number of subjects with solicited general AEs after first dose administration 5. Number of subjects with solicited general AEs after second dose administration 6. Number of subjects with solicited general AEs after booster dose administration 7. Number of subjects with any unsolicited AEs after first dose administration 8. Number of subjects with any unsolicited AEs after second dose administration 9. Number of subjects with any unsolicited AEs after booster dose administration 10. Number of subjects with abnormal hematological and biochemical laboratory ranges 11. Number of subjects with any MAEs 12. Number of subjects reporting any pIMDs 13. Number of subjects with SAEs 14. Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA 15. Concentrations of serum H1 stalk antibodies measured by ELISA 16. Number of sero | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Adjusted GMCs for anti-H1 HA stalk antibody, anti-H2 and anti-H18 antibody, measured by ELISA 2. Concentrations of serum H1 stalk antibodies measured by ELISA 3. Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA 4. Percentage of subjects with a >= 4-fold increase of anti-H1 stalk antibody concentration, measured by ELISA 5. Percentage of subjects with a >= 10-fold increase of anti-H1 stalk antibody concentration, measured by ELISA 6. MGI for anti-H1 stalk antibody measured by ELISA 7. Concentrations of anti-H2 and anti-H18 antibodies measured by ELISA 8. Number of seropositive subjects for anti-H2 and anti-H18 antibodies measured by ELISA 9. Percentage of subjects with a >= 4-fold increase of anti-H2 and anti-H18 antibody concentration measured by ELISA 10. Percentage of subjects with a >= 10-fold increase of anti-H2 and anti-H18 antibody concentration, measured by ELISA 11. MGI for anti-H2 and anti-H18 antibodies concentrations measured by ELISA 12. Titers for anti-H1N1 swine influenza and anti-IIV4-H1N1 antibodies measured by MN assay 13. Number of seropositive subjects for anti-H1N1 swine influenza and anti-IIV4-H1N1 antibodies measured by MN assay 14. Percentage of subjects with a >= 4-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers measured 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 16. MGI for anti-H1N1 swine influenza and anti-IIV4-H1N1 antibodies titers measured by MN assay;Timepoint(s) of evaluation of this end point: 1. 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 2. At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26 3. See 2 4. At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1 5. See 4 6. See 4 7. At Day 1, 29, Day 85, | — |
Countries
Belgium, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed