- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01046331
Novel Influenza A (H1N1) Surveillance Registry
13. april 2016 opdateret af: National Heart, Lung, and Blood Institute (NHLBI)
The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically.
While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure.
The burden of disease and resource utilization of these patients remains largely unknown.
The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
894
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alaska
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Anchorage, Alaska, Forenede Stater
- Alaska Native Medical Center
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Anchorage, Alaska, Forenede Stater
- The Children's Hospital at Providence
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Arizona
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Phoenix, Arizona, Forenede Stater
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Forenede Stater
- Arkansas Children's Hiospital
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California
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Fresno, California, Forenede Stater
- University of San Francisco-Fresno Medical Center
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Los Angeles, California, Forenede Stater
- Children's Hospital Los Angeles
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Oakland, California, Forenede Stater
- Children's Hospital and Research Center Oakland
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Orange, California, Forenede Stater
- Children's Hospital of Orange County
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Sacramento, California, Forenede Stater
- University of California, Davis Medical Center
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San Francisco, California, Forenede Stater
- UCSF-Moffitt Hospital
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San Francisco, California, Forenede Stater
- UCSF-San Francisco General Hospital
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San Francisco, California, Forenede Stater
- University of California, San Francisco (UCSF)-Moffitt Hospital
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San Francisco, California, Forenede Stater
- UCSF Children's Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater
- Denver's Children Hospital
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Denver, Colorado, Forenede Stater
- University of Colorado Health Sciences Center
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Denver, Colorado, Forenede Stater
- Centura St. Anthony Central Hospital
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Denver, Colorado, Forenede Stater
- Denver Health Medical Center
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Denver, Colorado, Forenede Stater
- Rose Medical Center
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Connecticut
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Hartford, Connecticut, Forenede Stater
- Connecticut Children's Medical Center
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New Haven, Connecticut, Forenede Stater
- Yale-New Haven Children's Hospital
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District of Columbia
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Washington, District of Columbia, Forenede Stater
- Children's National Medical Center
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Washington DC, District of Columbia, Forenede Stater
- Washington Hospital Center
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Florida
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Jacksonville, Florida, Forenede Stater
- Mayo Clinic at Jacksonville
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Miami, Florida, Forenede Stater
- Miami Children's Hospital
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Miami, Florida, Forenede Stater
- Holt'z Children's Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater
- Children's Healthcare of Atlanta at Egleston
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Hawaii
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Honolulu, Hawaii, Forenede Stater
- Kapi'olani Center for Women and Children
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Illinois
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Chicago, Illinois, Forenede Stater
- Children's Memorial Hospital
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Kentucky
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Louisville, Kentucky, Forenede Stater
- Kosair Children's Hospital
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater
- Earl K. Long Medical Center
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Baton Rouge, Louisiana, Forenede Stater
- Our Lady of the Lake Regional Medical Center
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New Orleans, Louisiana, Forenede Stater
- Ochsner Clinic Foundation
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New Orleans, Louisiana, Forenede Stater
- Medical Center of Louisiana
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New Orleans, Louisiana, Forenede Stater
- Tulane University Health Sciences Center
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Maryland
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Baltimore, Maryland, Forenede Stater
- Johns Hopkins Bayview Medical Center
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Baltimore, Maryland, Forenede Stater
- Johns Hopkins Hospital
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Baltimore, Maryland, Forenede Stater
- University of Maryland Shock Trauma Center
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Baltimore, Maryland, Forenede Stater
- Johns Hopkins Children's Center
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Baltimore, Maryland, Forenede Stater
- Union Memorial Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater
- Children's Hospital Boston
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Boston, Massachusetts, Forenede Stater
- Boston Medical Center
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Springfield, Massachusetts, Forenede Stater
- Baystate Medical Center
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Michigan
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Grand Rapids, Michigan, Forenede Stater
- Helen DeVos Children's Hospital
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Minnesota
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Minneapolis, Minnesota, Forenede Stater
- Children's Hospital and Clinics of Minnesota
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Minneapolis, Minnesota, Forenede Stater
- University of Minnesota Children's Hospital
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Rochester, Minnesota, Forenede Stater
- Rochester Methodist Hospital
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Rochester, Minnesota, Forenede Stater
- St. Mary's Hospital, Mayo Clinic
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Missouri
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St. Louis, Missouri, Forenede Stater
- St. Louis Children's Hospital
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St. Louis, Missouri, Forenede Stater
- SSM Cardinal Glennon Children's Medical Center
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Nebraska
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Omaha, Nebraska, Forenede Stater
- Children's Hospital of Nebraska
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater
- Darthmouth-Hitchcock Medical Center
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New York
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Bronx, New York, Forenede Stater
- Children's Hospital of Montefiore
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Rocherster, New York, Forenede Stater
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater
- University of North Carolina
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Durham, North Carolina, Forenede Stater
- Duke University Medical Center
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Durham, North Carolina, Forenede Stater
- Durham Regional Medical Center
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Durham, North Carolina, Forenede Stater
- Duke University Children's Hospital
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Greensboro, North Carolina, Forenede Stater
- Moses Cone Health System
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Greensboro, North Carolina, Forenede Stater
- Wesley Long Community Hospital
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Winston Salem, North Carolina, Forenede Stater
- Wake Forest University Baptist Medical Center
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Ohio
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Cleveland, Ohio, Forenede Stater
- University Hospitals Of Cleveland
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Cleveland, Ohio, Forenede Stater
- Cleveland Clinic Foundation
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Cleveland, Ohio, Forenede Stater
- MetroHealth Medical Center
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Columbus, Ohio, Forenede Stater
- Nationwide Children' Hospital
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater
- Children's Hospital at St. Francis
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Oregon
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Portland, Oregon, Forenede Stater
- Doernbecher Children's Hospital
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Forenede Stater
- The Children's Hospital of Philadelphia
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Tennessee
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Nashville, Tennessee, Forenede Stater
- Vanderbilt University Medical Center
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Nashville, Tennessee, Forenede Stater
- Monroe Carell Children's Hospital at Vanderbilt
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Texas
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Austin, Texas, Forenede Stater
- Dell Children's Medical Center of Central Texas
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Dallas, Texas, Forenede Stater
- University of Texas Southwestern Children's Medical Center
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Houston, Texas, Forenede Stater
- Texas Children's Hospital
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Houston, Texas, Forenede Stater
- Baylor College of Medicine
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Utah
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Murray, Utah, Forenede Stater
- Intermountain Medical Center
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Ogden, Utah, Forenede Stater
- McKay-Dee Hospital
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Provo, Utah, Forenede Stater
- Utah Valley Regional Medical Center
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Salt Lake City, Utah, Forenede Stater
- LDS Hospital
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Salt Lake City, Utah, Forenede Stater
- Primary Children's Medical Center
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Virginia
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Charlottesville, Virginia, Forenede Stater
- University of Virginia Medical Center
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Charlottesville, Virginia, Forenede Stater
- University of Virginia Children's Medical Center
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Washington
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Everett, Washington, Forenede Stater
- Providence Hospital
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Seattle, Washington, Forenede Stater
- University of Washington
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Seattle, Washington, Forenede Stater
- Seattle Children's Hospital
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Seattle, Washington, Forenede Stater
- Harborview Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater
- Children's Hospital of Wisconsin
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.
Beskrivelse
Inclusion Criteria:
- Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection
Exclusion Criteria:
- Influenza-like illness due to non-influenza disease and negative testing for influenza
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Adult H1N1
Patients admitted to adult ICU with confirmed or suspected H1N1 Influence infection
|
|
Pediatric H1N1
Patients admitted to pediatric ICU with confirmed or suspected H1N1 Influenza infection
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Todd W Rice, MD, MSc, Vanderbilt University
- Ledende efterforsker: B. Taylor Thompson, MD, Massachusetts General Hospital
- Ledende efterforsker: Adrienne G Randolph, MD, MSc, Boston Children's Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2009
Primær færdiggørelse (Faktiske)
1. april 2010
Studieafslutning (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først indsendt
8. januar 2010
Først indsendt, der opfyldte QC-kriterier
8. januar 2010
Først opslået (Skøn)
12. januar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. april 2016
Sidst verificeret
1. november 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 688
- N01HR056179 (Andet bevillings-/finansieringsnummer: NIH Contract Number)
- HSN268200536179C (Andet bevillings-/finansieringsnummer: NIH Contract Number)
Plan for individuelle deltagerdata (IPD)
Studiedata/dokumenter
-
Individuelt deltagerdatasæt
Informations-id: H1N1Oplysningskommentarer: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
- Studieformularer
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Influenza
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Gamaleya Research Institute of Epidemiology and...AfsluttetInfluenza A | Influenza A-virusinfektion | Influenza epidemi | Influenza H5N1Den Russiske Føderation
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NPO PetrovaxAfsluttetVaccine reaktion | Influenza | Influenza, menneske | Influenza A | Akut luftvejsinfektion | Influenza type B | Influenza | Influenza A H3N2 | Influenza A H1N1 | Influenza, menneske | Influenza epidemiDen Russiske Føderation
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Vanderbilt University Medical CenterHuman Vaccines ProjectAfsluttetVaccine reaktion | Influenza | Influenza, menneske | Influenza A | Influenza type B | Influenza A H3N2 | Influenza A H1N1Forenede Stater
-
Institute of Medical Biology, Chinese Academy of...Guangxi Zhuang Autonomous Region Center for Disease Prevention and ControlAktiv, ikke rekrutterendeInfluenza, menneske | Influenza type B | Influenza virale infektioner | Influenza aKina
-
ModernaTX, Inc.RekrutteringInfluenzaForenede Stater, Det Forenede Kongerige
-
Institute of Medical Biology, Chinese Academy of...Guangxi Zhuang Autonomous Region Center for Disease Prevention and ControlIkke rekrutterer endnuInfluenza, menneske | Influenza virale infektioner | Influenza B | Influenza, menneskelig forebyggelse | Influenza aKina
-
Novartis VaccinesAfsluttetInfluenza | Sæsonbestemt influenza | Menneskelig influenza | Influenza på grund af uspecificeret influenzavirusBelgien
-
Dre Pauline VetterUniversity of Zurich; University Hospital, Geneva; Swiss National Science... og andre samarbejdspartnereRekrutteringInfluenza sygdom; InfluenzaSchweiz
-
SeqirusNovartis VaccinesAfsluttetInfluenza | Influenza, menneske | Influenza A-virus, H5N1-undertype | Influenza, menneske | Influenza, fugleAustralien, Tyskland, Italien
-
Novartis VaccinesNovartis Vaccines and Diagnostics (formerly Chiron Vaccines)AfsluttetInfluenza sygdom; InfluenzaForenede Stater