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Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older

19 marca 2018 zaktualizowane przez: GlaxoSmithKline

A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older

The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

4048

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
      • Quebec, Kanada, G1W 4R4
        • GSK Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Kanada, V3K 3P4
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Kanada, A0A 1G0
        • GSK Investigational Site
      • Saint John's, Newfoundland and Labrador, Kanada, A1A 3R5
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Kanada, L6T 3T1
        • GSK Investigational Site
      • London, Ontario, Kanada, N5W 6A2
        • GSK Investigational Site
      • Ottawa, Ontario, Kanada, K1Y 4G2
        • GSK Investigational Site
      • Sudbury, Ontario, Kanada, P3E 1H5
        • GSK Investigational Site
      • Toronto, Ontario, Kanada, M3H 5S4
        • GSK Investigational Site
    • Quebec
      • Gatineau, Quebec, Kanada, J8Y 6S8
        • GSK Investigational Site
      • Quebec City, Quebec, Kanada, G1E 7G9
        • GSK Investigational Site
      • Sherbrooke, Quebec, Kanada, J1H 1Z1
        • GSK Investigational Site
      • St-Romulad, Quebec, Kanada, G6W 5M6
        • GSK Investigational Site
  • Stany Zjednoczone
    • Arizona
      • Mesa, Arizona, Stany Zjednoczone, 85213
        • GSK Investigational Site
      • Phoenix, Arizona, Stany Zjednoczone, 85020
        • GSK Investigational Site
      • Phoenix, Arizona, Stany Zjednoczone, 85028
        • GSK Investigational Site
    • California
      • Los Angeles, California, Stany Zjednoczone, 90057
        • GSK Investigational Site
    • Florida
      • Clearwater, Florida, Stany Zjednoczone, 33761
        • GSK Investigational Site
      • DeLand, Florida, Stany Zjednoczone, 32720
        • GSK Investigational Site
      • Delray Beach, Florida, Stany Zjednoczone, 33484
        • GSK Investigational Site
      • Jacksonville, Florida, Stany Zjednoczone, 32205
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60610
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, Stany Zjednoczone, 67207
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, Stany Zjednoczone, 40509
        • GSK Investigational Site
    • Maryland
      • Columbia, Maryland, Stany Zjednoczone, 21045
        • GSK Investigational Site
      • Rockville, Maryland, Stany Zjednoczone, 20850
        • GSK Investigational Site
    • Massachusetts
      • Milford, Massachusetts, Stany Zjednoczone, 01757
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, Stany Zjednoczone, 64114
        • GSK Investigational Site
    • New Jersey
      • Somers Point, New Jersey, Stany Zjednoczone, 08244
        • GSK Investigational Site
    • New York
      • Binghamton, New York, Stany Zjednoczone, 13901
        • GSK Investigational Site
      • Camillus, New York, Stany Zjednoczone, 13031
        • GSK Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, Stany Zjednoczone, 27103
        • GSK Investigational Site
    • Ohio
      • Willoughby Hills, Ohio, Stany Zjednoczone, 44094
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Stany Zjednoczone, 16506
        • GSK Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, Stany Zjednoczone, 02886
        • GSK Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, Stany Zjednoczone, 29303
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • GSK Investigational Site
    • Washington
      • Wenatchee, Washington, Stany Zjednoczone, 98801
        • 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 can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Male and female adults, >= 18 years of age at the time of the first vaccination.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Safety laboratory test results within the parameters specified in the protocol.
  • Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as demonstrated by signature on the informed consent document.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination; and
  • has a negative pregnancy test on the day of first vaccination; and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
  • Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
  • With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
  • Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination.
  • Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385).
  • Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of a temperature >= 38.0ºC (>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Receipt of systemic glucocorticoids within 1month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors, or imiquimod are allowed.
  • 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 significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
  • History of an acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
  • With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
  • Planned administration of any vaccine other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose.
  • Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; 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 vaccination.
  • Lactating or nursing women.

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: GSK2340274A Group
Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Biologiczny: GSK2340274A
One intramuscular injection
Eksperymentalny: GSK2340273A Group
Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Biologiczny: GSK2340273A
One intramuscular injection

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 21
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
At Day 21
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 0
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 0
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 21
A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 21
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 21
SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.
At Day 21
Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases
Ramy czasowe: From Day 14 post-vaccination up to study end (at Day 385)
The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.
From Day 14 post-vaccination up to study end (at Day 385)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Days 0 and 21

Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination.

The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Days 0 and 21
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Days 0 and 21
Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Days 0 and 21
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 42
Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 42
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 42
Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 42
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 182
Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 182
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 182
Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 182
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 42
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 42
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 182
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 182
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 42
A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 42
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 182
A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
At Day 182
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 42
SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
At Day 42
Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain
Ramy czasowe: At Day 182
SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
At Day 182
Number of A/California Influenza Related Cases
Ramy czasowe: From Day 0 up to the end of ILI surveillance (Day 385)
Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.
From Day 0 up to the end of ILI surveillance (Day 385)
Number of ILI Symptoms in All Reported ILI Cases
Ramy czasowe: From Day 0 up to the end of ILI surveillance (Day 385)
Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
From Day 0 up to the end of ILI surveillance (Day 385)
Number of ILI Symptoms in All Reported ILI Cases
Ramy czasowe: From Day 14 post-vaccination through the end of ILI surveillance (Day 385)
Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
From Day 14 post-vaccination through the end of ILI surveillance (Day 385)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Ramy czasowe: During the 7-day (Days 0-6) post-vaccination period
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Ramy czasowe: During the 7-day (Days 0-6) post-vaccination period
Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Ramy czasowe: At Days 7 and 21
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).
At Days 7 and 21
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Ramy czasowe: Throughout the entire study period (Day 0 - Day 385)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Throughout the entire study period (Day 0 - Day 385)
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Ramy czasowe: Throughout the entire study period (Day 0 - Day 385)
Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Throughout the entire study period (Day 0 - Day 385)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Ramy czasowe: Within the 42-day (Days 0-41) post-vaccination period
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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Within the 42-day (Days 0-41) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Ramy czasowe: Throughout the entire study period (Day 0 - Day 385)
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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Throughout the entire study period (Day 0 - Day 385)

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)

9 listopada 2009

Zakończenie podstawowe (Rzeczywisty)

10 stycznia 2011

Ukończenie studiów (Rzeczywisty)

1 lutego 2011

Daty rejestracji na studia

Pierwszy przesłany

17 września 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 września 2009

Pierwszy wysłany (Oszacować)

18 września 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 marca 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 marca 2018

Ostatnia weryfikacja

1 marca 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 113480

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: 113480
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formularz zgłoszenia przypadku z adnotacjami
    Identyfikator informacji: 113480
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  3. Specyfikacja zestawu danych
    Identyfikator informacji: 113480
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  4. Raport z badania klinicznego
    Identyfikator informacji: 113480
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protokół badania
    Identyfikator informacji: 113480
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  6. Indywidualny zestaw danych uczestnika
    Identyfikator informacji: 113480
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  7. Plan analizy statystycznej
    Identyfikator informacji: 113480
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register

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Badania kliniczne na GSK2340274A

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