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Afluria (Influenza Virus Vaccine) - Summary



AFLURIA, Influenza Virus Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using a continuous flow zonal centrifuge. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a "split virion". The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.

AFLURIA« is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

This indication is based on the immune response elicited by AFLURIA; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA (see Clinical Studies [14] ).

See all Afluria indications & dosage >>


Published Studies Related to Afluria (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 Afluria (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.

Safety and Immunogenicity Among Healthy Children Receiving Fluzone« Influenza Virus Vaccine (2012-2013 Formulation) [Completed]
The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine. Objective:

- To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in

a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age. Observational Objectives:

- To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine,

administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age.

- To submit remaining available sera from subjects to the Center for Biologics Evaluation

and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

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).

more trials >>

Page last updated: 2015-08-10

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