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Fluvirin (Influenza Virus Vaccine) - Summary

 
 



FLUVIRIN SUMMARY

FLUVIRIN« is a trivalent, sub-unit (purified surface antigen) influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. Each of the influenza virus strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with betapropiolactone. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of nonylphenol ethoxylate, a process which removes most of the internal proteins. The nonylphenol ethoxylate is removed from the surface antigen preparation. FLUVIRIN« is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered saline.

FLUVIRIN« is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza virus disease caused by influenza virus subtypes A and type B contained in the vaccine. [see DOSAGE FORMS AND STRENGTHS (3)]

FLUVIRIN« is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group.


See all Fluvirin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Fluvirin (Influenza Virus Vaccine)

Intranasal vaccination with a replication-deficient influenza virus induces heterosubtypic neutralising mucosal IgA antibodies in humans. [2014]
We investigated the cross-neutralising potential of serum and nasal wash samples from volunteers who were intranasally immunised once with a monovalent replication-deficient delNS1-H1N1 influenza virus vaccine (7.7log10TCID50/volunteer). Eight out of twelve (8/12) vaccinees responded to vaccination with a significant increase of antibody levels in serum IgG ELISA, mucosal IgA ELISA, MNA or HAI...

Safety of high dose trivalent inactivated influenza vaccine in pediatric patients with acute lymphoblastic leukemia. [2014]
CONCLUSIONS: No differences were noted between the HD and SD TIV groups for

Safety and immunogenicity of a modified-vaccinia-virus-Ankara-based influenza A H5N1 vaccine: a randomised, double-blind phase 1/2a clinical trial. [2014]
MVA-haemagglutinin-based H5N1 vaccine MVA-H5-sfMR in healthy individuals... INTERPRETATION: The MVA-based H5N1 vaccine was well tolerated and immunogenic and

A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. [2013]
lineages vs TIV in healthy children aged 3-17 years... CONCLUSIONS: QIV vs TIV showed superior immunogenicity for the additional B

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

more studies >>

Clinical Trials Related to Fluvirin (Influenza Virus Vaccine)

School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities [Completed]
Purpose of the study. The purpose of the project is to evaluate the feasibility, acceptability, and cost effectiveness of providing influenza vaccine in schools to children in grades Kindergarten through 6th grade. Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of influenza vaccination in school children. Hypothesis 2: Higher intensity parent notification about school based influenza vaccination does not increase immunization rates compared to low intensity. Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost neutral.

Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone« Vaccine in Adult and Elderly Subjects [Completed]
The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone« in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone«. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM [Completed]
The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective:

- To evaluate and describe the safety profile of revaccination with Fluzone ID for all

participants. Secondary Objective:

- To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001 [Completed]
This study is designed to evaluate the safety, tolerability, and immune response of LIQ001 mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65 years of age or older.

Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone« in Adults [Completed]
This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective:

- To demonstrate lot consistency of the Fluzone ID manufacturing process.

- To provide information concerning the immune response of Fluzone ID.

Secondary Objectives: Safety

- To describe the safety profile of subjects who receive of Fluzone ID.

more trials >>


Page last updated: 2015-08-10

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