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.
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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...
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.
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 >>
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