Evaluation of the Protective Efficacy and Safety of CR8020 in an Influenza Challenge
InfluenzaAfter prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
HIVCancerThis is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or...
InfluenzaThe aim of this study is to evaluate the immune response and the safety of one injection of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with any H1N1 pandemic vaccine will be enrolled as control. This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The impacted section is entry criteria.
Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China...
Influenza A Virus InfectionInfluenza B Virus InfectionThe aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections in China.
A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With...
InfluenzaThis partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.
CS-8958 Single Inhaled Dose in Elderly
InfluenzaThe purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups (Groups A, B, C and D) to receive the study drug or placebo (substance containing no medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be reviewed prior to administering a higher dose of treatment. Study procedures will include blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay. Participants will be involved in study related procedures for up to 6 weeks.
A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety...
AcuteUncomplicated Human InfluenzaThe purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
Efficacy Study of Early Versus Late Oseltamivir Administration for Treating and Preventing Influenza...
InfluenzaThis study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the duration and severity of influenza symptoms, and duration of viral shedding, in influenza patients receiving oseltamivir early and late relative to placebo. There are two main hypotheses in this study: The duration of influenza symptoms, mean severity score, and duration of viral shedding are reduced in patients who initiate oseltamivir treatment late (48 to 119 hours) compared to those receiving no antiviral therapy. Prior influenza vaccination (same season) reduces the duration of influenza symptoms and mean symptom severity in patients receiving oseltamivir after adjusting for age and timing of antiviral therapy (early versus late). There are two secondary hypotheses: The duration of influenza symptoms, mean severity score, and duration of viral shedding are reduced in patients with influenza who initiate oseltamivir treatment early (< 48 hours) versus late (48 to 119 hours). The incidence of secondary complications is lower in patients initiating oseltamivir therapy late relative to those receiving no antiviral therapy.
Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment
Influenza A Virus InfectionThis study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.
A Phase 2 Study to Evaluate Immune Responses of FluMist®
Influenza VaccineThe primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against influenza virus strains.