- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01114620
Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older
28 października 2019 zaktualizowane przez: GlaxoSmithKline
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A) in Adults 65 Years of Age or Older
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
50
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Fukuoka, Japonia, 813-8588
- GSK Investigational Site
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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
65 lat i starsze (Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Japanese male and female adults 65 years of age or older at time of vaccination.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Good general health as assessed by medical history and physical examination.
- 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. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
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 vaccination, and
- has agreed to continue adequate contraception and for 2 months after study vaccination.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- History of previous administration of a pandemic H1N1 vaccine.
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
- Presence or 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 an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
Diagnosed with cancer, or treatment for cancer within three years.
- Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
- Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and may enrol, but other histologic types of skin cancer are exclusionary.
- Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 10 mg/day of prednisone or equivalent when administered for > 2 weeks. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
- Receipt of any immunoglobulins and/or any blood products within three months of study enrolment 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 outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 months of receipt of seasonal influenza vaccination.
- Administration of any vaccines within 30 days before vaccination or planned administration before blood sampling at Day 21 and within 30 days prior to blood sampling at Day 182.
- Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Excessive underweight [Body Mass Index (BMI) < 18.5] or excessive obesity (BMI >= 30).
- Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
- Clinically or virologically confirmed influenza infection within 12 months preceding the study start.
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: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Arepanrix Group
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
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Intramuscular administration, one dose
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies
Ramy czasowe: At Day 21
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Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Day 21
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Number of Seroprotected Subjects for HI Antibodies
Ramy czasowe: At Day 21
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Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Day 21
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Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Ramy czasowe: At Day 21
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GMFR, also known as seroconversion factor (SCF), was defined as the 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.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Day 21
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Ramy czasowe: At Days 0 and 21
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Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Days 0 and 21
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Ramy czasowe: At Days 0 and 182
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Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Days 0 and 182
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Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Ramy czasowe: At Days 0 and 21
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:10.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Days 0 and 21
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Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Ramy czasowe: At Days 0 and 182
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:10.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Days 0 and 182
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Number of Seroconverted Subjects for HI Antibodies
Ramy czasowe: At Day 182
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SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Day 182
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Number of Seroprotected Subjects for HI Antibodies
Ramy czasowe: At Days 0 and 182
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Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Days 0 and 182
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GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Ramy czasowe: At Day 182
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GMFR, also known as seroconversion factor (SCF), was defined as the 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.
The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Day 182
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Ramy czasowe: At Days 0 and 21
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Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination.
The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
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At Days 0 and 21
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Ramy czasowe: At Days 0 and 182
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Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination.
The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
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At Days 0 and 182
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Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Ramy czasowe: At Days 0 and 21
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:8.
The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
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At Days 0 and 21
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Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Ramy czasowe: At Days 0 and 182
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:8.
The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
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At Days 0 and 182
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Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Ramy czasowe: At Day 21
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VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
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At Day 21
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Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease
Ramy czasowe: At Day 182
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VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
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At Day 182
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Ramy czasowe: During the 7-day (Days 0-6) post-vaccination period
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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.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Days With Solicited Local Symptoms
Ramy czasowe: During the 7-day (Days 0-6) post-vaccination period
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The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Ramy czasowe: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever ≥ 39.0°C to ≤ 40.0°C.
Related = symptom assessed by the investigator as causally related to the study vaccination.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Days With Solicited General Symptoms
Ramy czasowe: During the 7-day (Days 0-6) post-vaccination period
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The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Medically Attended AEs (MAEs)
Ramy czasowe: During the 21-day (Days 0-20) post-vaccination period
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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.
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During the 21-day (Days 0-20) post-vaccination period
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Number of Subjects With MAEs
Ramy czasowe: During the 42-day (Days 0-41) post-vaccination period
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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.
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During the 42-day (Days 0-41) post-vaccination period
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Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Ramy czasowe: During the entire study period (from Day 0 up to Day 182)
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pIMDs are 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.
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During the entire study period (from Day 0 up to Day 182)
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Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Ramy czasowe: At Day 0 and Day 7
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Among hematological and biochemical parameters assessed were alanine aminotransferase (ALAT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (ASAT), basophils, total bilirubin, bilirubin conjugated/direct, cholesterol, chloride, creatine, creatine kinase (CK), eosinophils, gamma-glutamyl transpeptidase (GGT), hematocrit, hemoglobin, potassium, lactate dyhydrogenase (LDH), lymphocytes, monocytes, sodium, neutrophils, platelets, protein, red blood cells, urate/uric acid, blood urea nitrogen (BUN) and white blood cells.
Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.
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At Day 0 and Day 7
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Number of Subjects With Abnormal Urine Sampling Parameters
Ramy czasowe: At Day 0 and Day 7
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Among assessed urine sampling parameters were glucose, protein, red blood cells and urobilinogen.
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At Day 0 and Day 7
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Number of Subjects With Unsolicited Adverse Events (AEs)
Ramy czasowe: During the 21-day (Days 0-20) post-vaccination period
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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.
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During the 21-day (Days 0-20) post-vaccination period
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Number of Subjects With Unsolicited AEs
Ramy czasowe: During the 42-day (Days 0-41) post-vaccination period
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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.
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During the 42-day (Days 0-41) post-vaccination period
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Number of Subjects With Serious Adverse Events (SAEs)
Ramy czasowe: During the entire study period (from Day 0 up to Day 182)
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SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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During the entire study period (from Day 0 up to Day 182)
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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)
17 maja 2010
Zakończenie podstawowe (Rzeczywisty)
5 listopada 2010
Ukończenie studiów (Rzeczywisty)
9 grudnia 2010
Daty rejestracji na studia
Pierwszy przesłany
29 kwietnia 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 kwietnia 2010
Pierwszy wysłany (Oszacować)
3 maja 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 listopada 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 października 2019
Ostatnia weryfikacja
1 października 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 114270
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
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Formularz zgłoszenia przypadku z adnotacjami
Identyfikator informacji: 114270Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Raport z badania klinicznego
Identyfikator informacji: 114270Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Specyfikacja zestawu danych
Identyfikator informacji: 114270Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Formularz świadomej zgody
Identyfikator informacji: 114270Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Indywidualny zestaw danych uczestnika
Identyfikator informacji: 114270Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Protokół badania
Identyfikator informacji: 114270Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Plan analizy statystycznej
Identyfikator informacji: 114270Komentarze 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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University Hospital, LilleCSL Behring; Laboratoire français de Fractionnement et de Biotechnologies; Oct... i inni współpracownicyZakończonyInfekcje pneumokokowe | Zapalenie płuc, bakteryjne | Zapalenie opon mózgowych, bakteryjne | Zapalenie ucha środkowego | Przewlekła infekcja zatok | Infekcja paciorkowcowa | Niedobór przeciwciał | Niedobór dopełniacza | Zakażenia Neisseria | Haemophilus InfluenzaFrancja
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QIAGEN Gaithersburg, IncZakończonyZakażenia syncytialnym wirusem oddechowym | Grypa A | Rinowirus | Grypa B | Panel zaawansowany QIAGEN ResPlex II | Zakażenie wywołane ludzkim wirusem paragrypy 1 | Paragrypa typu 2 | Paragrypa typu 3 | Paragrypa typu 4 | Ludzki metapneumowirus A/B | Wirus Coxsackie/echowirus | Adenowirusy typu B/C/E | Podtypy koronawirusa... i inne warunkiStany Zjednoczone
Badania kliniczne na Arepanrix™
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David ScheifeleCanadian Institutes of Health Research (CIHR); PHAC/CIHR Influenza Research...ZakończonyGrypa H1N1/2009Kanada
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Hopital du Sacre-Coeur de MontrealGlaxoSmithKlineZakończony
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University of British ColumbiaCanadian Institutes of Health Research (CIHR); PHAC/CIHR Influenza Research...Zakończony
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University Health Network, TorontoPrincess Margaret Hospital, CanadaZakończonyChłoniak | Szpiczak mnogi | Wirus grypy A, podtyp H1N1Kanada
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GlaxoSmithKlineZakończonyGrypaTajlandia, Australia, Meksyk, Kostaryka, Filipiny, Kolumbia, Singapur, Brazylia
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BaroNova, Inc.Zakończony
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Asklepios Kliniken Hamburg GmbHUniversity of KielZakończonyZarządzanie drogami oddechowymi | Maska krtaniowa | Intubacja światłowodowa
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CereVasc IncAlvaMed, Inc.; Simplified Clinical Data Systems, LLC; Bioscience Consulting, Inc.RekrutacyjnyWodogłowie | Wodogłowie, komunikacjaArgentyna
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London Health Sciences CentreUniversity of Western Ontario, Canada; Synaptive MedicalNieznanyUszkodzenie mózgu, przewlekłe | Cerebellar Cognitive Affective Syndrome | Mutyzm móżdżkowy