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Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

4. Juli 2018 aktualisiert von: GlaxoSmithKline

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza GSK2340272A and Fluarix™ 2009-2010 Vaccines When Co-administered in Elderly Subjects Aged 61 Years and Older

The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.

Studienübersicht

Detaillierte Beschreibung

The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.

The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

168

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Eskilstuna, Schweden, SE-631 88
        • GSK Investigational Site
      • Örebro, Schweden, SE-703 62
        • GSK Investigational Site

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

61 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Male or female subjects 61 years of age or older at the time of the first vaccination
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Access to a consistent means of telephone contact.

Exclusion Criteria:

  • Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
  • Previous administration of a pandemic influenza vaccine.
  • Administration of any vaccine within 30 days before first vaccination.
  • Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
  • Presence of evidence of substance abuse or 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 of an oral temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination.
  • Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome.
  • Serious chronic disease as determined by medical history and physical examination.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
  • Any known or suspected allergy to any constituent of influenza vaccines.
  • History of chronic alcohol consumption and/or drug abuse.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

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: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Pandemrix+Fluarix and Pandemrix+Placebo
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Intramuscular injection, 2 doses
Intramuscular injection, 1 dose
Andere Namen:
  • 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccine
Intramuscular injection, 1 dose
Experimental: Pandemrix+Placebo and Pandemrix+Fluarix
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Intramuscular injection, 2 doses
Intramuscular injection, 1 dose
Andere Namen:
  • 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccine
Intramuscular injection, 1 dose

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
Zeitfenster: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
Zeitfenster: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
Zeitfenster: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
Zeitfenster: Days 0, 21, 42, 182, 364

Titers are expressed as GMTs.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Days 0, 21, 42, 182, 364
Number of Seroconverted Subjects
Zeitfenster: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364

A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Number of Seroprotected Subjects
Zeitfenster: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Geometric Mean Fold Rise (GMFR)
Zeitfenster: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Number of Subjects With Titers Equal to or Above Titer 1:10
Zeitfenster: Days 0, 21, 42, 182, 364

The cut-off 1:10 was considered as seropositivity.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Days 0, 21, 42, 182, 364
Number of Subjects With Solicited Local and General Symptoms
Zeitfenster: Within 7 days (Day 0-Day 6) after each vaccination
Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).
Within 7 days (Day 0-Day 6) after each vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Zeitfenster: From Day 0 to Day 83
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
From Day 0 to Day 83
Number of Subjects With Adverse Events of Specific Interest
Zeitfenster: From Day 0 to Day 364
Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.
From Day 0 to Day 364
Number of Subjects With Serious Adverse Events (SAEs)
Zeitfenster: From Day 0 to Day 364
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.
From Day 0 to Day 364

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

12. September 2009

Primärer Abschluss (Tatsächlich)

23. September 2010

Studienabschluss (Tatsächlich)

23. September 2010

Studienanmeldedaten

Zuerst eingereicht

27. August 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. August 2009

Zuerst gepostet (Schätzen)

31. August 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. August 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juli 2018

Zuletzt verifiziert

1. September 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

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

  1. Kommentiertes Fallberichtsformular
    Informationskennung: 113525
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Datensatzspezifikation
    Informationskennung: 113525
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Einzelner Teilnehmerdatensatz
    Informationskennung: 113525
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistischer Analyseplan
    Informationskennung: 113525
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Einwilligungserklärung
    Informationskennung: 113525
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studienprotokoll
    Informationskennung: 113525
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinischer Studienbericht
    Informationskennung: 113525
    Informationskommentare: 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 .

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