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Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years

9 mei 2018 bijgewerkt door: GlaxoSmithKline

A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years

The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity & safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

4561

Fase

  • Fase 3

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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • London, Ontario, Canada, N5W 6A2
        • GSK Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 6C3
        • GSK Investigational Site
      • Woodstock, Ontario, Canada, N4S 4G3
        • GSK Investigational Site
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • GSK Investigational Site
      • Quebec City, Quebec, Canada, G1E 7G9
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 4J6
        • GSK Investigational Site
      • St-Romuald, Quebec, Canada, G6W 5M6
        • GSK Investigational Site
  • Verenigde Staten
    • Alabama
      • Huntsville, Alabama, Verenigde Staten, 35802
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85020
        • GSK Investigational Site
    • California
      • Anaheim, California, Verenigde Staten, 92801
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32216
        • GSK Investigational Site
      • Melbourne, Florida, Verenigde Staten, 32935
        • GSK Investigational Site
      • Miami, Florida, Verenigde Staten, 33143
        • GSK Investigational Site
      • Pembroke Pines, Florida, Verenigde Staten, 33024
        • GSK Investigational Site
    • Georgia
      • Stockbridge, Georgia, Verenigde Staten, 30281
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60610
        • GSK Investigational Site
      • Peoria, Illinois, Verenigde Staten, 61602
        • GSK Investigational Site
    • Indiana
      • South Bend, Indiana, Verenigde Staten, 46601
        • GSK Investigational Site
    • Kansas
      • Lenexa, Kansas, Verenigde Staten, 66219
        • GSK Investigational Site
      • Wichita, Kansas, Verenigde Staten, 67207
        • GSK Investigational Site
    • Louisiana
      • Metairie, Louisiana, Verenigde Staten, 70006
        • GSK Investigational Site
    • Maryland
      • Rockville, Maryland, Verenigde Staten, 20850
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten, 63141
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, Verenigde Staten, 59801
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89104
        • GSK Investigational Site
    • New Jersey
      • Edison, New Jersey, Verenigde Staten, 08817
        • GSK Investigational Site
    • New York
      • Poughkeepsie, New York, Verenigde Staten, 12601
        • GSK Investigational Site
      • Rochester, New York, Verenigde Staten, 14609
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Verenigde Staten, 27612
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44122
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Verenigde Staten, 16506
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15236
        • GSK Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, Verenigde Staten, 29303
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Verenigde Staten, 78705
        • GSK Investigational Site
      • Fort Worth, Texas, Verenigde Staten, 76135
        • GSK Investigational Site
      • San Angelo, Texas, Verenigde Staten, 76904
        • 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

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • A male or female 18 years of age or greater at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
  • Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.
  • Access to a consistent means of telephone contact.
  • Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Exclusion Criteria:

  • Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • An oral temperature ≥37.8º C, 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 infection.
  • Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
  • Administration of any vaccines within 30 days before study enrollment.
  • Previous administration of any H5N1 vaccine.
  • Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines; 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 test result prior to either vaccination.
  • Lactating or nursing.
  • Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.

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: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Influenza A (H5N1) 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo-vergelijker: Placebo 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Placebo
Two intramuscular injections at Days 0 and 21.
Experimenteel: Influenza A (H5N1) >64Y Group
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo-vergelijker: Placebo >64Y Group
Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Placebo
Two intramuscular injections at Days 0 and 21.
Experimenteel: Influenza A (H5N1) Group
Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo-vergelijker: Placebo Group
Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Placebo
Two intramuscular injections at Days 0 and 21.
Experimenteel: Influenza A (H5N1) 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo-vergelijker: Placebo 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Placebo
Two intramuscular injections at Days 0 and 21.
Experimenteel: Influenza A (H5N1) >60Y Group
Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo-vergelijker: Placebo >60Y Group
Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Biologisch: Placebo
Two intramuscular injections at Days 0 and 21.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Tijdsspanne: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Tijdsspanne: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With Any Solicited Local Symptoms.
Tijdsspanne: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any Solicited General Symptoms.
Tijdsspanne: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Tijdsspanne: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
Number of Subjects With Serious Adverse Events (SAEs)
Tijdsspanne: From Day 0 through Day 182 and through Day 379.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
From Day 0 through Day 182 and through Day 379.
Number of Subjects With Medically Attended Events (MAEs)
Tijdsspanne: From Day 0 through Day 182 and through Day 364.
From Day 0 through Day 182 and through Day 364.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Tijdsspanne: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
Tijdsspanne: At Month 6 (Day 182) post Dose 1
At Month 6 (Day 182) post Dose 1
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Tijdsspanne: At Month 6 (Day 182) after Dose 1
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
At Month 6 (Day 182) after Dose 1
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Tijdsspanne: At Month 6 (Day 182) after Dose 1
At Month 6 (Day 182) after Dose 1
Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
Tijdsspanne: At Month 6 (Day 182) after Dose 1
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.
At Month 6 (Day 182) after Dose 1
Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
Tijdsspanne: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
Tijdsspanne: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Titers were expressed as Geometric Mean Titers (GMTs).
At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

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.

Algemene publicaties

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

23 januari 2008

Primaire voltooiing (Werkelijk)

15 oktober 2008

Studie voltooiing (Werkelijk)

19 maart 2009

Studieregistratiedata

Eerst ingediend

28 januari 2008

Eerst ingediend dat voldeed aan de QC-criteria

5 februari 2008

Eerst geplaatst (Schatting)

15 februari 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2018

Laatste update ingediend die voldeed aan QC-criteria

9 mei 2018

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 110464

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. Statistisch analyseplan
    Informatie-ID: 110464
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisch onderzoeksrapport
    Informatie-ID: 110464
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Geannoteerd casusrapportformulier
    Informatie-ID: 110464
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Gegevensset individuele deelnemers
    Informatie-ID: 110464
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specificatie gegevensset
    Informatie-ID: 110464
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formulier geïnformeerde toestemming
    Informatie-ID: 110464
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  7. Leerprotocool
    Informatie-ID: 110464
    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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