Flumist (Influenza Virus Vaccine Live Intranasal) - Summary

FLUMIST SUMMARY

Influenza Virus Vaccine Live, Intranasal (FluMist™) is a live trivalent nasally administered vaccine intended for active immunization for the prevention of influenza.

FOR NASAL ADMINISTRATION ONLY

FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age.

FluMist is not indicated for immunization of individuals less than 5 years of age, or 50 years of age and older, or for therapy of influenza, nor will it protect against infections and illness caused by infectious agents other than influenza A or B viruses.

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NEWS HIGHLIGHTS

Published Studies Related to Flumist (Influenza Virus Vaccine)

Preflucel®: a Vero-cell culture-derived trivalent influenza vaccine. [2012]
Vaccination is the principal means to reduce the impact of influenza infection...

Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. [2012]
vaccine (TIV) in a healthy pediatric population... CONCLUSION: CCIV produced in mammalian cell culture is a safe, well-tolerated and

A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. [2011.11.08]
CONCLUSIONS: Adjuvant systems can be safely used in influenza vaccines, including the adjuvant monophosphoryl lipid A (MPL) derived from Bordetella pertussis with squalene and aluminum hydroxide, MPL with aluminum hydroxide, and squalene and aluminum hydroxide. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Oil-in-water emulsion adjuvant with influenza vaccine in young children. [2011.10.13]
BACKGROUND: The efficacy of inactivated influenza vaccines is known to be poor in infants and young children... CONCLUSIONS: Influenza vaccine with the MF59 adjuvant is efficacious against PCR-confirmed influenza in infants and young children. (Funded by Novartis Vaccines and Diagnostics; ClinicalTrials.gov number, NCT00644059.).

Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok(R)) against influenza in healthy adults: a randomized, placebo-controlled trial. [2011.10.13]
BACKGROUND: Development of influenza vaccines that do not use embryonated eggs as the substrate for vaccine production is a high priority. We conducted this study to determine the protective efficacy a recombinant, baculovirus-expressed seasonal trivalent influenza virus hemagglutinin (rHA0) vaccine (FluBlok((R)))... CONCLUSIONS: Trivalent rHA0 vaccine was safe, immunogenic and effective in the prevention of culture confirmed influenza illness, including protection against drift variants. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

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Clinical Trials Related to Flumist (Influenza Virus Vaccine)

Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children [Completed]

- To compare immune responses to measles, mumps, rubella, and varicella antigens following

vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1).

- To compare immune responses to the three strains of influenza (H1N1, H3N2, and B)

following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary:

- To assess the safety and tolerability of concurrent administration of FluMist with

MMRIIÒ and VARIVAXÒ.

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children [Active, not recruiting]

Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children [Completed]
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination.

Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-Adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases [Active, not recruiting]
This phase III is designed to confirm the previous trial results evaluating the safety, clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines' adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic diseases.

Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults [Completed]
The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.

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