Influenza, Human News - LARVOL Sigma

Influenza, Human

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38 Mechanisms of Action

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||||||||||  Agriflu (trivalent influenza virus vaccine) / CSL Behring
New P2 trial:  Safety and Immunogenicity of a Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above (clinicaltrials.gov) -  Jul 8, 2012
P2, N=126, Completed,  Sponsor: Novartis Vaccines

|||||||||| Enrollment closed: Studies of Avian Influenza Transmission to Humans in Egypt (clinicaltrials.gov) - Jul 8, 2012
P=N/A, N=1000, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
Recruiting --> Active, not recruiting

||||||||||  Influvac (influenza virus surface antigens) / Abbott
New P3 trial:  Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season (clinicaltrials.gov) -  Jul 2, 2012
P3, N=120, Completed,  Sponsor: Abbott Biologicals

|||||||||| Enrollment closed: Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine (clinicaltrials.gov) - Jul 2, 2012
P1, N=84, Active, not recruiting, Sponsor: Crucell Holland BV
Recruiting --> Active, not recruiting Not yet recruiting --> Active, not recruiting

|||||||||| New P3 trial: Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (clinicaltrials.gov) - Jun 26, 2012
P3, N=110, Completed, Sponsor: Crucell Holland BV

|||||||||| New P3 trial: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults (clinicaltrials.gov) - Jun 21, 2012
P3, N=113, Completed, Sponsor: GlaxoSmithKline

|||||||||| New P2 trial: Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine (clinicaltrials.gov) - Jun 19, 2012
P2, N=309, Completed, Sponsor: PATH Vaccine Solutions

||||||||||  vancomycin / Generic mfg.
Enrollment change:  Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly (clinicaltrials.gov) -  Jun 18, 2012
P1, N=22, Completed,  Sponsor: Mayo Clinic
Not yet recruiting --> Active, not recruiting N=40 --> 22

|||||||||| New P1 trial: A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NP+M1 (clinicaltrials.gov) - Jun 18, 2012
P1, N=18, Active, not recruiting, Sponsor: University of Oxford

||||||||||  vancomycin / Generic mfg.
Trial completion:  Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly (clinicaltrials.gov) -  Jun 18, 2012
P1, N=22, Completed,  Sponsor: Mayo Clinic
N=40 --> 22 Recruiting --> Completed

|||||||||| Clinical: UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients (clinicaltrials.gov) - Jun 17, 2012
P=N/A, N=600, Recruiting, Sponsor: University of Arkansas

|||||||||| New P1/2 trial: MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly (clinicaltrials.gov) - Jun 17, 2012
P1/2, N=0, Withdrawn, Sponsor: Department of Veterans Affairs

|||||||||| Clinical: Orofacial Evaluation in Women With Rheumatoid Arthritis (clinicaltrials.gov) - Jun 10, 2012
P=N/A, N=150, Completed, Sponsor: Federal University of São Paulo

|||||||||| New P1 trial: Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine (clinicaltrials.gov) - Jun 10, 2012
P1, N=84, Active, not recruiting, Sponsor: Crucell Holland BV

|||||||||| Enrollment change: Real-time Influenza Vaccine Surveillance (clinicaltrials.gov) - Jun 7, 2012
P=N/A, N=400, Completed, Sponsor: Columbia University
Recruiting --> Completed N=3750 --> 400

||||||||||  amantadine/ribavirin/oseltamivir (ADS-8902) / Supernus Pharma
Enrollment change:  PO206: Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects (clinicaltrials.gov) -  Jun 7, 2012
P2, N=2, Completed,  Sponsor: Adamas Pharmaceuticals, Inc.
N=3750 --> 400 N=250 --> 2

|||||||||| Enrollment closed: FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record (clinicaltrials.gov) - Jun 7, 2012
P=N/A, N=14988, Active, not recruiting, Sponsor: Columbia University
N=250 --> 2 Recruiting --> Active, not recruiting

|||||||||| Trial completion: Real-time Influenza Vaccine Surveillance (clinicaltrials.gov) - Jun 7, 2012
P=N/A, N=400, Completed, Sponsor: Columbia University
Recruiting --> Active, not recruiting Recruiting --> Completed

|||||||||| Trial completion: TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations (clinicaltrials.gov) - Jun 7, 2012
P=N/A, N=9213, Completed, Sponsor: Columbia University
Recruiting --> Completed Recruiting --> Completed

||||||||||  amantadine/ribavirin/oseltamivir (ADS-8902) / Supernus Pharma
Trial completion:  PO206: Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects (clinicaltrials.gov) -  Jun 7, 2012
P2, N=2, Completed,  Sponsor: Adamas Pharmaceuticals, Inc.
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK
Enrollment change:  Vaccination of Children Following Allogeneic Stem Cell Transplantation (clinicaltrials.gov) -  Jun 5, 2012
P3, N=53, Completed,  Sponsor: Heinrich-Heine University, Duesseldorf
Active, not recruiting --> Completed N=81 --> 53

||||||||||  Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK
Trial completion:  Vaccination of Children Following Allogeneic Stem Cell Transplantation (clinicaltrials.gov) -  Jun 5, 2012
P3, N=53, Completed,  Sponsor: Heinrich-Heine University, Duesseldorf
N=81 --> 53 Active, not recruiting --> Completed

|||||||||| Trial completion: A Double-blind, Randomised, Parallel Group,Comparative Study With Rose-hip Liquid and Placebo Given to Healthy Volunteers in the Winter Season Aiming to Evaluate the Occurences of Flu and Catching a Cold (clinicaltrials.gov) - Jun 4, 2012
P3, N=120, Completed, Sponsor: Hyben Vital ApS
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Panblok (influenza vaccine) / Sanofi
New P1/2 trial:  Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults (clinicaltrials.gov) -  Jun 3, 2012
P1/2, N=341, Completed,  Sponsor: Protein Sciences Corporation

||||||||||  oseltamivir / Generic mfg., nitazoxanide / Generic mfg.
New P3 trial:  Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza (clinicaltrials.gov) -  May 30, 2012
P3, N=1400, Recruiting,  Sponsor: Romark Laboratories L.C.

||||||||||  mycophenolate mofetil / Generic mfg.
Trial withdrawal:  Flu/TBI in Treating Patients Not Responding to Previous Hormone Therapy (clinicaltrials.gov) -  May 30, 2012
P2, N=0, Withdrawn,  Sponsor: OHSU Knight Cancer Institute
Active, not recruiting --> Completed Terminated --> Withdrawn

|||||||||| New P1 trial: Seasonal Influenza DNA Vaccine & Seasonal Influenza Trivalent Inactivated Vaccine (TIV) in Children & Adolescents (clinicaltrials.gov) - May 30, 2012
P1, N=75, Completed, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

||||||||||  Fluarix (influenza virus trivalent vaccine) / GSK
New P3 trial:  A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above (clinicaltrials.gov) -  May 24, 2012
P3, N=119, Completed,  Sponsor: GlaxoSmithKline

||||||||||  oseltamivir / Generic mfg.
Enrollment open:  A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants. (clinicaltrials.gov) -  May 20, 2012
P3, N=166, Recruiting,  Sponsor: Hoffmann-La Roche
Terminated --> Withdrawn Active, not recruiting --> Recruiting

||||||||||  VGX-3400X / GeneOne, Inovio
Trial completion:  Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults (clinicaltrials.gov) -  May 20, 2012
P1, N=32, Completed,  Sponsor: Inovio Pharmaceuticals
Active, not recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  Afluria (influenza vaccine) / CSL Behring
Trial completion:  A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira (clinicaltrials.gov) -  May 16, 2012
P4, N=120, Completed,  Sponsor: CSL Limited
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: The Effect of Proximity on Flu-Shot Participation (clinicaltrials.gov) - May 15, 2012
P=N/A, N=1912, Completed, Sponsor: National Bureau of Economic Research, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial termination: Influenza Vaccine Post Allogeneic Transplant (clinicaltrials.gov) - May 15, 2012
P=N/A, N=73, Terminated, Sponsor: Masonic Cancer Center, University of Minnesota
Active, not recruiting --> Completed Recruiting --> Terminated; Lack of patients and no longer influenza vaccine season.

|||||||||| Enrollment change: Influenza Vaccine Post Allogeneic Transplant (clinicaltrials.gov) - May 15, 2012
P=N/A, N=73, Terminated, Sponsor: Masonic Cancer Center, University of Minnesota
Recruiting --> Terminated; Lack of patients and no longer influenza vaccine season. N=120 --> 73

|||||||||| New P1 trial: A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2 (clinicaltrials.gov) - May 9, 2012
P1, N=333, Completed, Sponsor: Novavax

|||||||||| New P1 trial: A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1 (clinicaltrials.gov) - May 7, 2012
P1, N=333, Completed, Sponsor: Novavax

||||||||||  favipiravir / Generic mfg.
Enrollment change:  Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza (clinicaltrials.gov) -  May 3, 2012
P2, N=530, Completed,  Sponsor: MDVI, LLC
N=120 --> 73 N=384 --> 530

|||||||||| Clinical: Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain (clinicaltrials.gov) - May 3, 2012
P=N/A, N=501, Completed, Sponsor: GlaxoSmithKline

||||||||||  favipiravir / Generic mfg.
Trial completion:  Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza (clinicaltrials.gov) -  May 3, 2012
P2, N=530, Completed,  Sponsor: MDVI, LLC
N=384 --> 530 Recruiting --> Completed

||||||||||  Ampligen (rintatolimod) / AIM ImmunoTech
New P1/2 trial:  Safety Study of FluMist With and Without Ampligen (clinicaltrials.gov) -  May 2, 2012
P1/2, N=72, Recruiting,  Sponsor: Hemispherx Biopharma

||||||||||  Afluria (influenza vaccine) / CSL Behring
New P4 trial:  A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira (clinicaltrials.gov) -  May 2, 2012
P4, N=120, Completed,  Sponsor: CSL Limited

|||||||||| Trial completion: Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age (clinicaltrials.gov) - Apr 29, 2012
P3, N=175, Completed, Sponsor: Novartis Vaccines
Recruiting --> Completed Recruiting --> Completed

|||||||||| New P1 trial: DNA-based Influenza Vaccine in the Elderly (clinicaltrials.gov) - Apr 25, 2012
P1, N=50, Active, not recruiting, Sponsor: University of Manitoba

|||||||||| Trial completion: Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine (clinicaltrials.gov) - Apr 22, 2012
P2, N=4560, Completed, Sponsor: Novavax
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| New P4 trial: Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients (clinicaltrials.gov) - Apr 22, 2012
P4, N=440, Not yet recruiting, Sponsor: University of Alberta

|||||||||| Trial withdrawal: PIPET C: A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza (clinicaltrials.gov) - Apr 21, 2012
P=N/A, N=0, Withdrawn, Sponsor: Kirby Institute
Active, not recruiting --> Completed Not yet recruiting --> Withdrawn

|||||||||| Trial withdrawal: PIPET A: A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza (clinicaltrials.gov) - Apr 21, 2012
P=N/A, N=0, Withdrawn, Sponsor: Kirby Institute
Not yet recruiting --> Withdrawn Not yet recruiting --> Withdrawn

|||||||||| Trial withdrawal: A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: PIPET B (clinicaltrials.gov) - Apr 21, 2012
P=N/A, N=0, Withdrawn, Sponsor: Kirby Institute
Not yet recruiting --> Withdrawn Not yet recruiting --> Withdrawn

|||||||||| Enrollment change: PIPET C: A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza (clinicaltrials.gov) - Apr 21, 2012
P=N/A, N=0, Withdrawn, Sponsor: Kirby Institute
Not yet recruiting --> Withdrawn N=500 --> 0

|||||||||| Enrollment change: PIPET A: A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza (clinicaltrials.gov) - Apr 21, 2012
P=N/A, N=0, Withdrawn, Sponsor: Kirby Institute
N=500 --> 0 N=1000 --> 0