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Fluzone (Influenza Virus Vaccine) - Summary

 
 



FLUZONE SUMMARY

Fluzone (Influenza Virus Vaccine) and Fluzone High-Dose (Influenza Virus Vaccine) are inactivated influenza virus vaccines, for intramuscular use, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge.

Fluzone® is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. [See Dosage Forms and Strengths (3) .]

Fluzone High-Dose is an inactivated influenza virus vaccine indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. [See Dosage Forms and Strengths (3) .]

This indication is based on the immune response elicited by Fluzone High-Dose; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose.


See all Fluzone indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Fluzone (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 Fluzone (Influenza Virus Vaccine)

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.

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.

Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation. [Completed]
To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).

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.

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects [Completed]
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. 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.

more trials >>

Reports of Suspected Fluzone (Influenza Virus Vaccine) Side Effects

Orthostatic Hypotension (4)Constipation (4)Ileus (4)Dyspnoea (4)Wheezing (3)Death (3)Lymphadenopathy (2)Chills (2)Oropharyngeal Pain (2)Pyrexia (2)more >>


Page last updated: 2015-08-10

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