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Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over

9 mei 2018 bijgewerkt door: GlaxoSmithKline

Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over

This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1596

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Soeborg, Denemarken, 2860
        • GSK Investigational Site
  • Estland
      • Tartu, Estland, 50417
        • GSK Investigational Site
  • Noorwegen
      • Bergen, Noorwegen, 5094
        • GSK Investigational Site
      • Elverum, Noorwegen, 2408
        • GSK Investigational Site
      • Hamar, Noorwegen, 2317
        • GSK Investigational Site
      • Stavanger, Noorwegen, 4010
        • GSK Investigational Site

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

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female aged 65 years or older at the time of the vaccination.
  • 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.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) 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 a vaccine not foreseen by the study protocol up to Visit 2 after vaccination.
  • Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
  • Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
  • Chronic administration (defined as more than 14 days) 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 (no laboratory testing required).
  • 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 or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
  • Any medical conditions in which intramuscular injections are contraindicated.

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: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GSK576389A- 2006/2007 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
Biologisch: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
Experimenteel: GSK576389A - 2006/2007 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
Biologisch: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
Actieve vergelijker: Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
Biologisch: Fluarix [NH 2006/07 season]
Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
Experimenteel: GSK576389A - 2007/2008 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
Biologisch: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Experimenteel: GSK576389A - 2007/2008 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
Biologisch: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Actieve vergelijker: Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Biologisch: Fluarix [NH 2007/08 season]
Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
Tijdsspanne: At Days 0 and 21
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
At Days 0 and 21

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duur van aangevraagde lokale AE's
Tijdsspanne: Tijdens een follow-upperiode van 7 dagen (dag 0-6) na vaccinatie
Duur werd gedefinieerd als het aantal dagen met een willekeurige graad van lokale symptomen.
Tijdens een follow-upperiode van 7 dagen (dag 0-6) na vaccinatie
Duur van aangevraagde algemene AE's
Tijdsspanne: Tijdens een follow-upperiode van 7 dagen (dag 0-6) na vaccinatie
Duur werd gedefinieerd als het aantal dagen met een willekeurige graad van algemene symptomen.
Tijdens een follow-upperiode van 7 dagen (dag 0-6) na vaccinatie
Aantal proefpersonen dat enige, graad 3 en gerelateerde ongevraagde AE's rapporteert
Tijdsspanne: Tijdens een follow-upperiode van 21 dagen (dag 0-20) na vaccinatie
Ongevraagde bijwerkingen dekt alle bijwerkingen die zijn gemeld naast de bijwerkingen die tijdens de klinische studie zijn aangevraagd en alle gevraagde symptomen die zijn begonnen buiten de gespecificeerde periode van follow-up voor gevraagde symptomen. Elk werd gedefinieerd als het optreden van een ongevraagd symptoom, ongeacht de intensiteitsgraad of relatie tot vaccinatie. Graad 3 was een gebeurtenis die normale activiteiten verhinderde en gerelateerd werd gedefinieerd als een ongevraagde bijwerking die door de onderzoeker werd beoordeeld als oorzakelijk verband met de onderzoeksvaccinatie.
Tijdens een follow-upperiode van 21 dagen (dag 0-20) na vaccinatie
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
Tijdsspanne: At Days 0 and 21
Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.
At Days 0 and 21
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Tijdsspanne: At Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
At Day 21
HI Antibody Seroconversion Factors
Tijdsspanne: At Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
At Day 21
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Tijdsspanne: At Days 0 and 21
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
At Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Tijdsspanne: During a 7-day follow-up period (Day 0-6) after vaccination
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.
During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Tijdsspanne: During a 7-day follow-up period (Day 0-6) after vaccination
Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Tijdsspanne: During a 21-day follow-up period (Day 0-20) after vaccination
MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.
During a 21-day follow-up period (Day 0-20) after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Tijdsspanne: During a 21-day follow-up period (Day 0-20) after vaccination
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 or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
During a 21-day follow-up period (Day 0-20) after vaccination

Medewerkers en onderzoekers

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

Sponsor

GlaxoSmithKline

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

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

20 september 2007

Primaire voltooiing (Werkelijk)

1 november 2007

Studie voltooiing (Werkelijk)

2 november 2007

Studieregistratiedata

Eerst ingediend

19 september 2007

Eerst ingediend dat voldeed aan de QC-criteria

19 september 2007

Eerst geplaatst (Schatting)

20 september 2007

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2018

Laatste update ingediend die voldeed aan QC-criteria

9 mei 2018

Laatst geverifieerd

1 november 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 110620

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Bestudeer gegevens/documenten

  1. Geannoteerd casusrapportformulier
    Informatie-ID: 110620
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulier geïnformeerde toestemming
    Informatie-ID: 110620
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Leerprotocool
    Informatie-ID: 110620
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Klinisch onderzoeksrapport
    Informatie-ID: 110620
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specificatie gegevensset
    Informatie-ID: 110620
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Gegevensset individuele deelnemers
    Informatie-ID: 110620
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistisch analyseplan
    Informatie-ID: 110620
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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