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Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

28 maja 2018 zaktualizowane przez: GlaxoSmithKline

A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older

Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

This study has 2 phases:

The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51.

The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

5075

Faza

  • Faza 3

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Estonia
      • Tallinn, Estonia, 10617
        • GSK Investigational Site
      • Tartu, Estonia, 50417
        • GSK Investigational Site
  • Federacja Rosyjska
      • Ekaterinburg, Federacja Rosyjska, 620078
        • GSK Investigational Site
      • Ekaterinburg, Federacja Rosyjska, 620028
        • GSK Investigational Site
      • Kazan, Federacja Rosyjska, 420015
        • GSK Investigational Site
      • Novokuznetsk, Federacja Rosyjska, 654063
        • GSK Investigational Site
      • Saratov, Federacja Rosyjska
        • GSK Investigational Site
  • Francja
      • Caen cedex 4, Francja, 14052
        • GSK Investigational Site
      • Lagord, Francja, 17140
        • GSK Investigational Site
      • Nantes, Francja, 44093
        • GSK Investigational Site
      • Paris Cedex 18, Francja, 75877
        • GSK Investigational Site
      • Poitiers, Francja, 86000
        • GSK Investigational Site
      • Rouen, Francja, 76100
        • GSK Investigational Site
  • Hiszpania
      • Barcelona, Hiszpania, 08036
        • GSK Investigational Site
      • Barcelona, Hiszpania, 08035
        • GSK Investigational Site
      • Madrid, Hiszpania, 28041
        • GSK Investigational Site
      • Madrid, Hiszpania, 28006
        • GSK Investigational Site
      • Madrid, Hiszpania, 28040
        • GSK Investigational Site
      • Marid, Hiszpania, 28040
        • GSK Investigational Site
      • Valencia, Hiszpania, 46017
        • GSK Investigational Site
      • Valencia, Hiszpania, 46014
        • GSK Investigational Site
  • Holandia
      • Rotterdam, Holandia, 3011 EN
        • GSK Investigational Site
      • Rotterdam, Holandia, 3015 GE
        • GSK Investigational Site
  • Niemcy
      • Berlin, Niemcy, 14057
        • GSK Investigational Site
      • Berlin, Niemcy, 10117
        • GSK Investigational Site
      • Berlin, Niemcy, 10787
        • GSK Investigational Site
      • Hamburg, Niemcy, 22143
        • GSK Investigational Site
      • Hamburg, Niemcy, 20249
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Niemcy, 81667
        • GSK Investigational Site
      • Muenchen, Bayern, Niemcy, 80799
        • GSK Investigational Site
      • Regensburg, Bayern, Niemcy, 93053
        • GSK Investigational Site
      • Wuerzburg, Bayern, Niemcy, 97070
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Niemcy, 19055
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Niemcy, 30519
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Witten, Nordrhein-Westfalen, Niemcy, 58455
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Niemcy, 01067
        • GSK Investigational Site
      • Leipzig, Sachsen, Niemcy, 04229
        • GSK Investigational Site
      • Leipzig, Sachsen, Niemcy, 04103
        • GSK Investigational Site
  • Szwecja
      • Eskilstuna, Szwecja, SE-631 88
        • GSK Investigational Site
      • Stockholm, Szwecja, SE-141 86
        • 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:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female aged 18 years or above at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

  • 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 30 days after the second vaccination.
  • Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • History of chronic alcohol consumption and/or drug abuse.
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study.
  • Lactating women
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.

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: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: GSK1562902A Group
Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.
Biologiczny: Adjuvanted pandemic influenza candidate vaccine
2 doses, intramuscular injection
Aktywny komparator: Fluarix+Placebo Group
Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.
Biologiczny: Fluarix
One intramuscular injection
Biologiczny: Placebo
One intramuscular injection

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects With Solicited Local Symptoms
Ramy czasowe: During a 7 day follow-up period after each dose of vaccine and overall.
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
During a 7 day follow-up period after each dose of vaccine and overall.
Number of Subjects With Solicited General Symptoms (Dose 1)
Ramy czasowe: During the 7-day (Days 0-6) after Dose 1
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
During the 7-day (Days 0-6) after Dose 1
Number of Subjects With Solicited General Symptoms (Dose 2)
Ramy czasowe: During the 7-day (Days 0-6) after Dose 2
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
During the 7-day (Days 0-6) after Dose 2
Number of Subjects With Solicited General Symptoms (Across Doses)
Ramy czasowe: During the 7-day (Days 0-6) post vaccination across dosses
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
During the 7-day (Days 0-6) post vaccination across dosses
Number of Subjects With Unsolicited Adverse Events (AEs)
Ramy czasowe: During the 21st Day (Days 0-20) post Dose 1
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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
During the 21st Day (Days 0-20) post Dose 1
Number of Subjects With AEs
Ramy czasowe: During the 30 Day (Days 0-29) post Dose 2
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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
During the 30 Day (Days 0-29) post Dose 2
Number of Subjects With Serious Adverse Events (SAEs)
Ramy czasowe: From Day 0 to Day 180
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 to Day 180
Number of Subjects With New Onset Chronic Diseases (NOCDs)
Ramy czasowe: From Day 0 to Day 180
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
From Day 0 to Day 180
Number of Subjects With Medically Significant Conditions (MSCs)
Ramy czasowe: From Day 0 to Day 51
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
From Day 0 to Day 51

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
Ramy czasowe: At Day 0 (PRE), 21 and 42
Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
At Day 0 (PRE), 21 and 42
Number of Seroconverted Subjects Against H5N1
Ramy czasowe: At Day 21 and Day 42
Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
At Day 21 and Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
Ramy czasowe: At Day 21 and Day 42
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
At Day 21 and Day 42
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
Ramy czasowe: At Day 0 (PRE), Day 21 and Day 42
Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
At Day 0 (PRE), Day 21 and Day 42

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 (Rzeczywisty)

1 maja 2006

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2007

Ukończenie studiów (Rzeczywisty)

31 lipca 2007

Daty rejestracji na studia

Pierwszy przesłany

26 kwietnia 2006

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 kwietnia 2006

Pierwszy wysłany (Oszacować)

27 kwietnia 2006

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 lipca 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 maja 2018

Ostatnia weryfikacja

1 kwietnia 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 107064
  • 107217 (Inny identyfikator: GSK)

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. Formularz świadomej zgody
    Identyfikator informacji: 107064
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  2. Specyfikacja zestawu danych
    Identyfikator informacji: 107064
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protokół badania
    Identyfikator informacji: 107064
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  4. Raport z badania klinicznego
    Identyfikator informacji: 107064
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  5. Indywidualny zestaw danych uczestnika
    Identyfikator informacji: 107064
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 107064 are summarised with study 107217 on the GSK Clinical Study Register.
  6. Plan analizy statystycznej
    Identyfikator informacji: 107064
    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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