Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People
22. August 2018 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
370
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Berlin, Deutschland, 13347
- GSK Investigational Site
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Berlin, Deutschland, 12627
- GSK Investigational Site
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Berlin, Deutschland, 10435
- GSK Investigational Site
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Hamburg, Deutschland, 22415
- GSK Investigational Site
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Hamburg, Deutschland, 22335
- GSK Investigational Site
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Baden-Wuerttemberg
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Gueglingen, Baden-Wuerttemberg, Deutschland, 74363
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Deutschland, 68161
- GSK Investigational Site
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Rudersberg, Baden-Wuerttemberg, Deutschland, 73635
- GSK Investigational Site
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Weinheim, Baden-Wuerttemberg, Deutschland, 69469
- GSK Investigational Site
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Bayern
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Augsburg, Bayern, Deutschland, 86150
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Deutschland, 45359
- GSK Investigational Site
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Koeln, Nordrhein-Westfalen, Deutschland, 51069
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Deutschland, 55131
- GSK Investigational Site
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Rhaunen, Rheinland-Pfalz, Deutschland, 55624
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Deutschland, 01067
- GSK Investigational Site
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Freital, Sachsen, Deutschland, 01705
- GSK Investigational Site
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Leipzig, Sachsen, Deutschland, 04103
- GSK Investigational Site
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Deutschland, 39112
- GSK Investigational Site
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Wolmirstedt, Sachsen-Anhalt, Deutschland, 39326
- GSK Investigational Site
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Rotterdam, Niederlande, 3011 EN
- GSK Investigational Site
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Rotterdam, Niederlande, 3011 AA
- GSK Investigational Site
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Eskilstuna, Schweden, SE-631 88
- GSK Investigational Site
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Karlskrona, Schweden, SE-371 41
- GSK Investigational Site
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Uppsala, Schweden, SE-751 85
- GSK Investigational Site
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
19 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Aktiver 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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Aktiver 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Dauer angeforderter allgemeiner AEs
Zeitfenster: Tag 0-6
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Die Dauer wurde als Anzahl der Tage mit beliebigen Graden von Allgemeinsymptomen definiert.
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Tag 0-6
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Dauer angeforderter lokaler AEs
Zeitfenster: Tag 0-6
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Die Dauer wurde als Anzahl der Tage mit beliebigen Graden lokaler Symptome definiert.
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Tag 0-6
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Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
15. Oktober 2009
Primärer Abschluss (Tatsächlich)
27. Mai 2010
Studienabschluss (Tatsächlich)
27. Mai 2010
Studienanmeldedaten
Zuerst eingereicht
1. Oktober 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Oktober 2009
Zuerst gepostet (Schätzen)
9. Oktober 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
21. September 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. August 2018
Zuletzt verifiziert
1. Mai 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 113094
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiendaten/Dokumente
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Studienprotokoll
Informationskennung: 113094Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Statistischer Analyseplan
Informationskennung: 113094Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einzelner Teilnehmerdatensatz
Informationskennung: 113094Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Klinischer Studienbericht
Informationskennung: 113094Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 113094Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einwilligungserklärung
Informationskennung: 113094Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Kommentiertes Fallberichtsformular
Informationskennung: 113094Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .