Delving into the Latest Updates on Seasonal influenza virus vaccine(Baxter International, Inc.) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Multivalent vaccine

Synonyms

Preflucel, Seasonal influenza virus vaccine(Takeda), Vero cell-derived trivalent seasonal influenza vaccine(Takeda)

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication-

Originator Organization

Baxter International, Inc.

Active Organization

Shire Pharmaceuticals Services Ltd.

Inactive Organization

Resilience Government Services, Inc.Baxter Healthcare Corp.Alachua Government Services, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

Austria (01 Sep 2010),

Influenza, Human

Regulation-

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Randomized, Age-stratified, Double Blind, Controlled Phase 3 Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older

The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process:
1. induces immune responses comparable to that produced by the current manufacturing process
2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine
3. demonstrates consistency of immune response among three different lots.

Start Date01 Jan 2013

Sponsor / Collaborator-

EUCTR2011-003106-24-AT

/ Not yet recruitingNot Applicable

Effectiveness of PREFLUCEL vaccination against infection with seasonalinfluenza virus in an adult and elderly population aged 50 years and older - PREFLUCEL effectiveness study in adults 50 years and older

Start Date06 Oct 2011

Sponsor / Collaborator

Baxter Innovations GmbH

NCT00943657

/ CompletedPhase 3

An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult and Elderly Population

The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.

Start Date01 Jun 2009

Sponsor / Collaborator

Resilience Government Services, Inc.

100 Clinical Results associated with Seasonal influenza virus vaccine(Baxter International, Inc.)

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100 Translational Medicine associated with Seasonal influenza virus vaccine(Baxter International, Inc.)

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100 Patents (Medical) associated with Seasonal influenza virus vaccine(Baxter International, Inc.)

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100 Deals associated with Seasonal influenza virus vaccine(Baxter International, Inc.)

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