Media Articles Related to Relenza (Zanamivir)
ACIP Nixes Nasal Spray Influenza Vaccine for Next Season
Source: Medscape Infectious Diseases Headlines [2016.06.23]
The CDC's ACIP has recommended that live attenuated influenza vaccine, the nasal spray influenza vaccine, should not be used because it was ineffective during the last three influenza seasons.
Medscape Medical News
ACIP Dumps FluMist for Upcoming Influenza Season
Source: MedPage Today Infectious Disease [2016.06.23]
(MedPage Today) -- Interim recommendation not to use intranasal spray
Source: MedicineNet Bioterrorism Specialty [2016.04.28]
Title: Flu (Influenza)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/28/2016 12:00:00 AM
NIH study finds factors that may influence influenza vaccine effectiveness
Source: Flu / Cold / SARS News From Medical News Today [2016.04.20]
The long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited, new research suggests.
UGA, Sanofi Pasteur develop new vaccine for H1N1 influenza
Source: Flu / Cold / SARS News From Medical News Today [2016.03.30]
Researchers at the University of Georgia and Sanofi Pasteur, the vaccines division of Sanofi, have announced the development of a vaccine that protects against multiple strains of both seasonal and...
Published Studies Related to Relenza (Zanamivir)
Efficacy of oseltamivir-zanamivir combination compared to each monotherapy for seasonal influenza: a randomized placebo-controlled trial. [2010.11.02]
CONCLUSIONS: In adults with seasonal influenza A mainly H3N2 virus infection, the oseltamivir-zanamivir combination appeared less effective than oseltamivir monotherapy, and not significantly more effective than zanamivir monotherapy. Despite the theoretical potential for the reduction of the emergence of antiviral resistance, the lower effectiveness of this combination calls for caution in its use in clinical practice. TRIAL REGISTRATION: www.ClinicalTrials.govNCT00799760.
A comparison of the effectiveness of zanamivir and oseltamivir for the treatment of influenza A and B. [2008.01]
OBJECTIVE: To compare the effectiveness of zanamivir with oseltamivir for influenza A and B... CONCLUSION: Zanamivir therapy is more effective than oseltamivir for the treatment of influenza B infection.
Efficacy and Safety of Inhaled Zanamivir in the Prevention of Influenza in Community-Dwelling, High-Risk Adult and Adolescent Subjects: A 28-day, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. [2007.08]
Background: Influenza can cause significant morbidity and mortality in subjects at high risk for complications, including the elderly (age >/=65 years) and those with chronic respiratory, cardiovascular, or metabolic conditions...
Safety and efficacy of nebulized zanamivir in hospitalized patients with serious influenza. [2003.06]
Influenza is an important cause of hospitalization due to lower respiratory tract involvement for which there is no specific antiviral treatment with proven efficacy. We conducted a double-blind, randomized, placebo-controlled trial to assess the tolerability and efficacy of nebulized zanamivir (16 mg four times a day) in combination with rimantadine compared to rimantadine with nebulized saline for treating influenza in adults hospitalized with influenza...
Zanamivir: a significant reduction in viral load during treatment in military conscripts with influenza. 
A randomized, double-blind, placebo-controlled, parallel-group trial performed at 5 residential units of the Finnish Defence Forces was conducted to assess the antiviral activity, efficacy and safety of inhaled zanamivir for the treatment of naturally acquired influenza... Zanamivir rapidly reduced viral load following the start of therapy compared with placebo and was well tolerated.
Clinical Trials Related to Relenza (Zanamivir)
Prophylactic Efficacy of Relenza Against Influenza A and B [Completed]
In response to the European regulatory authorities, GSK is conducting a post-marketing
observational study to assess the efficacy of Relenza when used as prophylaxis against
1. Determine the frequency of patients who received Relenza from October 2006 through
April 2009, and among them the number who have no concurrent diagnosis of influenza,
i. e., those receiving Relenza for prophylaxis, and among these the number who have a
family member with a medical visit for influenza within three days preceding the above
indentified patient's dispensing of Relenza. This is to determine the feasibility of
conducting detailed analysis.
2. If analysis is feasible then tabulate the frequency of influenza-like-illness and
respiratory outcomes in users of prophylactic Relenza and their family members and in
family members of persons using Relenza for the treatment of influenza (i. e., index
3. If analysis is feasible then estimate the direct effect of prophylactic Relenza on the
occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of
Relenza treatment of influenza on susceptible family members, and the total effect of
Relenza (treatment plus prophylaxis).
METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like
illness and respiratory outcomes in persons for whom some household members (index cases)
have had a medical visit associated with a diagnosis of influenza. The exposed individuals
to the index case will be categorized into one of four cohorts according to whether the
exposed person received prophylactic Relenza or no antiviral treatment and by whether the
index family member with a diagnosis of influenza received antiviral treatment.
Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing
disease in susceptible family members, and the total effect of disease reduction when both
index cases and susceptible family members are treated will be obtained from different
comparisons between cohorts, as outlined below.
The research will cover the first three influenza seasons during which Relenza has been
indicated for prophylactic use in the United States. These will be from October through
April of 2006-2009.
A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects [Withdrawn]
This study is a 4 period study to see if there is any interaction between
Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults [Completed]
Zanamivir is a potent and highly selective inhibitor of the influenza virus neuraminidase.
Intravenous (IV) zanamivir is being developed for treatment of hospitalized patients with
influenza, especially for those patients who may be in greatest need of parenteral influenza
antiviral agents. This study is a pharmacokinetic (PK) study to evaluate the
safety/tolerability and pharmacokinetic profiles of IV zanamivir 300 milligrams (mg) and 600
mg in Chinese healthy subjects. Subjects will be randomized to receive either 300 mg or 600
mg IV zanamivir as a single dose followed by repeated dose every 12 hours (h) for 5 days.
Subjects will be contacted or will return to study center for a follow-up visit, 7 days
after the last dose or withdrawal from the study. Total number of subjects planned for
enrollment will be 24 such that approximately 10 subjects complete dosing and critical
assessments in each dose cohort. The total duration of the study will be approximately 6
weeks from screening to follow-up.
RelenzaŽ Sentinel Site Monitoring Program in Japan [Completed]
To collect background information of patients receiving a prescription for RelenzaŽ and
study risk factors etc. for adverse drug reactions collected through spontaneous reporting.
In particular, to characterize the types and incidences of adverse events, serious adverse
events, and adverse drug reactions and to investigate risk factors for them in patient
populations that are regarded to be at high risk for novel influenza A (H1N1)and in which
the use experience of RelenzaŽ has not been enough (such as pregnant women, infants, elderly
persons, and those with decreased physical function) in accordance with the PFSB/SD
Notification 0904, No. 2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW,
dated 4th September 2009.
To compare the data with the safety data collected in overseas sentinel site monitoring
A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers [Completed]
Approximately 40 healthy subjects will be enrolled. Each subject will participate in the
study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day
washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each
dosing period and will remain in the unit until Day 2. Each subject will receive a single
dose of each of the four treatments on Day 1 of each treatment period in a randomized
fashion. Subjects will be discharged from the clinical research unit after the completion
of all assessments on Day 2 of each period and return approximately 5-7 days later for the
next dose period. Serial pharmacokinetic samples will be collected for up to 24 hours
following each treatment.
Reports of Suspected Relenza (Zanamivir) Side Effects
Abnormal Behaviour (40),
Loss of Consciousness (8),
Depressed Level of Consciousness (8),
Pyrexia (7), more >>