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

9. maj 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4561

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35802
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85020
        • GSK Investigational Site
    • California
      • Anaheim, California, Forenede Stater, 92801
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32216
        • GSK Investigational Site
      • Melbourne, Florida, Forenede Stater, 32935
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33143
        • GSK Investigational Site
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • GSK Investigational Site
    • Georgia
      • Stockbridge, Georgia, Forenede Stater, 30281
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60610
        • GSK Investigational Site
      • Peoria, Illinois, Forenede Stater, 61602
        • GSK Investigational Site
    • Indiana
      • South Bend, Indiana, Forenede Stater, 46601
        • GSK Investigational Site
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • GSK Investigational Site
      • Wichita, Kansas, Forenede Stater, 67207
        • GSK Investigational Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • GSK Investigational Site
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20850
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63141
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, Forenede Stater, 59801
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89104
        • GSK Investigational Site
    • New Jersey
      • Edison, New Jersey, Forenede Stater, 08817
        • GSK Investigational Site
    • New York
      • Poughkeepsie, New York, Forenede Stater, 12601
        • GSK Investigational Site
      • Rochester, New York, Forenede Stater, 14609
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27612
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44122
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Forenede Stater, 16506
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15236
        • GSK Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • GSK Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76135
        • GSK Investigational Site
      • San Angelo, Texas, Forenede Stater, 76904
        • GSK Investigational Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo komparator: 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.
Biologisk: Placebo
Two intramuscular injections at Days 0 and 21.
Eksperimentel: 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.
Biologisk: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo komparator: 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.
Biologisk: Placebo
Two intramuscular injections at Days 0 and 21.
Eksperimentel: 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.
Biologisk: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo komparator: 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.
Biologisk: Placebo
Two intramuscular injections at Days 0 and 21.
Eksperimentel: 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.
Biologisk: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo komparator: 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.
Biologisk: Placebo
Two intramuscular injections at Days 0 and 21.
Eksperimentel: 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.
Biologisk: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Placebo komparator: 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.
Biologisk: Placebo
Two intramuscular injections at Days 0 and 21.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: From Day 0 through Day 182 and through Day 364.
From Day 0 through Day 182 and through Day 364.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

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.

Generelle publikationer

Hjælpsomme links

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

23. januar 2008

Primær færdiggørelse (Faktiske)

15. oktober 2008

Studieafslutning (Faktiske)

19. marts 2009

Datoer for studieregistrering

Først indsendt

28. januar 2008

Først indsendt, der opfyldte QC-kriterier

5. februar 2008

Først opslået (Skøn)

15. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2018

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 110464

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

  1. Statistisk analyseplan
    Informations-id: 110464
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisk undersøgelsesrapport
    Informations-id: 110464
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annoteret sagsbetænkningsformular
    Informations-id: 110464
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individuelt deltagerdatasæt
    Informations-id: 110464
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datasætspecifikation
    Informations-id: 110464
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formular til informeret samtykke
    Informations-id: 110464
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokol
    Informations-id: 110464
    Oplysningskommentarer: 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 .

Kliniske forsøg med Influenza

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