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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A in Adults 18 to 60 Years of Age

16 juni 2016 bijgewerkt door: GlaxoSmithKline

An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A Administered in Adults 18 to 60 Years of Age

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 60 years of age.

Studie Overzicht

Studietype

Ingrijpend

Fase

  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Male or female adults who are 18 to 60years 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 screening safety laboratory tests that figure in eligibility assessment must be within reference ranges before dosing.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo-groep
Proefpersonen in deze groep krijgen twee doses placebo met een interval van 21 dagen
One dose of placebo administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of placebo administered IM at the deltoid region of dominant arm at Day 21
Experimenteel: Formulation 1 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 1 at a 21 day interval
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
Experimenteel: Formulation 2 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 2 at a 21 day interval
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
Experimenteel: Formulation 3 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 3 at a 21 day interval
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
Experimenteel: Formulation 4 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 4 at a 21 day interval
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
Experimenteel: Formulation 5 Group
Subjects in this group will receive two doses of GSK3277509A H7N9 vaccine formulation 5 at a 21 day interval
One dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of dominant arm at Day 21

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
Tijdsspanne: At Day 42.
At Day 42.
Occurrence of each solicited local symptom
Tijdsspanne: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
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
Tijdsspanne: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
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
Tijdsspanne: At the Day 0, 7, 21, 28 and 42 visits.
At the Day 0, 7, 21, 28 and 42 visits.
Occurrence of unsolicited adverse events (AEs)
Tijdsspanne: 21 days after each dose.
21 days after each dose.
Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)[Active Phase]
Tijdsspanne: From Day 0 until Day 42.
From Day 0 until Day 42.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Evaluation of adjuvant effect as assessed by vaccine-homologous hemagglutination inhibition (HI) antibody titers
Tijdsspanne: At Day 42.
At Day 42.
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for plain antigen vaccine group
Tijdsspanne: At Day 42.
At Day 42.
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers.
Tijdsspanne: GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
Humoral immune response in terms of vaccine-homologous (H7N9) neutralizing (MN) antibody titres.
Tijdsspanne: GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.
GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum.
Tijdsspanne: GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.
GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.
Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers for each study group by age stratum (18-40 years; 41-60 years)
Tijdsspanne: GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.
GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.
Occurrence of MAEs, pIMDs and SAEs
Tijdsspanne: Until the Month 12 visit.
Until the Month 12 visit.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2016

Primaire voltooiing (Verwacht)

1 juni 2016

Studie voltooiing (Verwacht)

1 mei 2017

Studieregistratiedata

Eerst ingediend

19 juni 2014

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2014

Eerst geplaatst (Schatting)

30 juni 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

20 juni 2016

Laatste update ingediend die voldeed aan QC-criteria

16 juni 2016

Laatst geverifieerd

1 juni 2016

Meer informatie

Termen gerelateerd aan deze studie

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