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

9 maja 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

4561

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Biologiczny: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Komparator placebo: 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.
Biologiczny: Placebo
Two intramuscular injections at Days 0 and 21.
Eksperymentalny: 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.
Biologiczny: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Komparator placebo: 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.
Biologiczny: Placebo
Two intramuscular injections at Days 0 and 21.
Eksperymentalny: 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.
Biologiczny: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Komparator placebo: 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.
Biologiczny: Placebo
Two intramuscular injections at Days 0 and 21.
Eksperymentalny: 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.
Biologiczny: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Komparator placebo: 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.
Biologiczny: Placebo
Two intramuscular injections at Days 0 and 21.
Eksperymentalny: 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.
Biologiczny: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Komparator placebo: 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.
Biologiczny: Placebo
Two intramuscular injections at Days 0 and 21.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Ramy czasowe: 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)
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: From Day 0 through Day 182 and through Day 364.
From Day 0 through Day 182 and through Day 364.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

GlaxoSmithKline

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

23 stycznia 2008

Zakończenie podstawowe (Rzeczywisty)

15 października 2008

Ukończenie studiów (Rzeczywisty)

19 marca 2009

Daty rejestracji na studia

Pierwszy przesłany

28 stycznia 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 lutego 2008

Pierwszy wysłany (Oszacować)

15 lutego 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 czerwca 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 maja 2018

Ostatnia weryfikacja

1 października 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 110464

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Badanie danych/dokumentów

  1. Plan analizy statystycznej
    Identyfikator informacji: 110464
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  2. Raport z badania klinicznego
    Identyfikator informacji: 110464
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formularz zgłoszenia przypadku z adnotacjami
    Identyfikator informacji: 110464
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  4. Indywidualny zestaw danych uczestnika
    Identyfikator informacji: 110464
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specyfikacja zestawu danych
    Identyfikator informacji: 110464
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formularz świadomej zgody
    Identyfikator informacji: 110464
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  7. Protokół badania
    Identyfikator informacji: 110464
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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