Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People
22. august 2018 opdateret af: GlaxoSmithKline
Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects
The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine.
Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time.
For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
370
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Rotterdam, Holland, 3011 EN
- GSK Investigational Site
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Rotterdam, Holland, 3011 AA
- GSK Investigational Site
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Eskilstuna, Sverige, SE-631 88
- GSK Investigational Site
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Karlskrona, Sverige, SE-371 41
- GSK Investigational Site
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Uppsala, Sverige, SE-751 85
- GSK Investigational Site
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Berlin, Tyskland, 13347
- GSK Investigational Site
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Berlin, Tyskland, 12627
- GSK Investigational Site
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Berlin, Tyskland, 10435
- GSK Investigational Site
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Hamburg, Tyskland, 22415
- GSK Investigational Site
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Hamburg, Tyskland, 22335
- GSK Investigational Site
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Baden-Wuerttemberg
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Gueglingen, Baden-Wuerttemberg, Tyskland, 74363
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Tyskland, 68161
- GSK Investigational Site
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Rudersberg, Baden-Wuerttemberg, Tyskland, 73635
- GSK Investigational Site
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Weinheim, Baden-Wuerttemberg, Tyskland, 69469
- GSK Investigational Site
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Bayern
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Augsburg, Bayern, Tyskland, 86150
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Tyskland, 45359
- GSK Investigational Site
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Koeln, Nordrhein-Westfalen, Tyskland, 51069
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Tyskland, 55131
- GSK Investigational Site
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Rhaunen, Rheinland-Pfalz, Tyskland, 55624
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Tyskland, 01067
- GSK Investigational Site
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Freital, Sachsen, Tyskland, 01705
- GSK Investigational Site
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Leipzig, Sachsen, Tyskland, 04103
- GSK Investigational Site
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Tyskland, 39112
- GSK Investigational Site
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Wolmirstedt, Sachsen-Anhalt, Tyskland, 39326
- GSK Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse.
- A male or female aged 19-43 years or >=66 years at the time of the vaccination and who participated in the study NCT00760617 and completed the 6-month follow-up.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception for 2 months after the vaccination.
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
- Vaccination against influenza since January 2009 with a seasonal influenza vaccine.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation or pre-existing laboratory screening tests.
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature >=37.5°C on oral setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study.
- Any medical conditions in which IM injections are contraindicated
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: New generation influenza vaccine GSK2186877A Group
Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
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Single dose, intramuscular injection
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Aktiv komparator: Fluarix elderly Group
Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
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Single dose, intramuscular injection
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Aktiv komparator: Fluarix young Group
Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
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Single dose, intramuscular injection
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Varighed af anmodede generelle AE'er
Tidsramme: Dag 0-6
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Varighed blev defineret som antal dage med en hvilken som helst grad af generelle symptomer.
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Dag 0-6
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Varighed af anmodede lokale AE'er
Tidsramme: Dag 0-6
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Varighed blev defineret som antal dage med en hvilken som helst grad af lokale symptomer.
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Dag 0-6
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Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Tidsramme: Day 0-6
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Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.
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Day 0-6
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Tidsramme: Day 0-6
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Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C.
For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
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Day 0-6
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Tidsramme: Day 0-20
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Unsolicited AE covers any AE 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.
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Day 0-20
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Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit
Tidsramme: Day 0-179
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For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
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Day 0-179
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Number of Subjects Reporting AEs of Specific Interest (AESI)
Tidsramme: Day 0-179
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AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
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Day 0-179
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180
Tidsramme: Up to Day 180
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
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Up to Day 180
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180
Tidsramme: After Day 180
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
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After Day 180
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Tidsramme: Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains.
The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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Day 0 and Day 21
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HI Antibody Titers at Day 180
Tidsramme: Day 180
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Antibody titers were expressed as GMTs against separate vaccine strains.
The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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Day 180
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The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21
Tidsramme: Day 0 and Day 21
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Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
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Day 0 and Day 21
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The Number of Subjects Seropositive to HI Antibodies at Day 180
Tidsramme: Day 180
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Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
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Day 180
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The Number of Subjects Seroconverted to HI Antibodies at Day 21
Tidsramme: Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
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Day 21
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The Number of Subjects Seroconverted to HI Antibodies at Day 180
Tidsramme: Day 180
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
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Day 180
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HI Antibody Seroconversion Factors (SCF) at Day 21
Tidsramme: At Day 21
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SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
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At Day 21
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HI Antibody SCF at Day 180
Tidsramme: At Day 180
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SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
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At Day 180
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The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21
Tidsramme: At Day 0 and Day 21
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A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.
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At Day 0 and Day 21
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The Number of Subjects Seroprotected to HI Antibodies at Day 180
Tidsramme: At Day 180
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A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.
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At Day 180
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The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21
Tidsramme: At Day 0 and Day 21
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The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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At Day 0 and Day 21
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The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180
Tidsramme: At Day 180
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The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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At Day 180
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
15. oktober 2009
Primær færdiggørelse (Faktiske)
27. maj 2010
Studieafslutning (Faktiske)
27. maj 2010
Datoer for studieregistrering
Først indsendt
1. oktober 2009
Først indsendt, der opfyldte QC-kriterier
8. oktober 2009
Først opslået (Skøn)
9. oktober 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. august 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 113094
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
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Studieprotokol
Informations-id: 113094Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informations-id: 113094Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: 113094Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk undersøgelsesrapport
Informations-id: 113094Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasætspecifikation
Informations-id: 113094Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Formular til informeret samtykke
Informations-id: 113094Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoteret sagsbetænkningsformular
Informations-id: 113094Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .