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:
induces immune responses comparable to that produced by the current manufacturing process
has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine
demonstrates consistency of immune response among three different lots.

Start Date01 Jan 2013

Sponsor / Collaborator

Baxter Healthcare Ltd

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.)

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

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

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

01 Jul 2012·Expert Review of VaccinesQ2 · MEDICINE

Preflucel®: a Vero-cell culture-derived trivalent influenza vaccine

Q2 · MEDICINE

Review

Author: Yuen, Candice ; Tambyah, Paul Anantharajah ; Chan, Yue

Vaccination is the principal means to reduce the impact of influenza infection. Effective vaccination programs require a reliable and safe production system. Traditionally, influenza vaccines are produced in embryonated chicken eggs. Over the last two decades, new cell culture-derived vaccines have been licensed and manufactured, and other vaccines are still in various phases of development. Vero cells have been used for the development of a wide variety of vaccines including influenza vaccines. Pandemic and avian influenza vaccines derived from Vero cells have been shown to be well tolerated and immunogenic in animal and Phase I-II clinical studies. A Phase III randomized, double-blind, placebo-controlled trial of a trivalent influenza vaccine produced in Vero-cell culture was conducted in 7250 adults aged 18-49 years. Overall protective efficacy for antigenically matched influenza vaccine was 78.5%. The vaccine was well tolerated with no treatment-related serious adverse events and compared favorably with egg-derived vaccines from previous trials. Vero-cell-derived influenza vaccines have the potential to be an important parts of the influenza vaccine strategy, especially if an avian-derived strain becomes predominant or the demand outstrips the capacity of egg-based production systems.

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

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Influenza, Human	AT	Shire Pharmaceuticals Services Ltd.	01 Sep 2010

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 2	US	Baxter Healthcare Corp.	01 Nov 2007

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