Delving into the Latest Updates on Influenza Virus Vaccine(Seqirus) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Influenza virus vaccine(Novartis Pharma AG), Agriflu

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Influenza A virus infectionInfluenza B virus infectionInfluenza, Human

Originator Organization

Seqirus GmbH

Active Organization-

Inactive Organization

Seqirus GmbHNovartis Vaccines & Diagnostics, Inc.

Seqirus UK Ltd.

Drug Highest PhaseWithdrawn

First Approval Date

US (27 Nov 2009),

Influenza A virus infectionInfluenza B virus infection

Regulation-

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Based on information from several years of looking at Influenza vaccination doctors know that:
Older adults suffer the worst illness and most deaths caused by Influenza illness of all age groups.
Older adults do not seem to get as good a level of protection as younger adults after getting the usual seasonal Influenza vaccine.
Because of this information doctors wonder if one of the new seasonal Influenza vaccines is more effective or more acceptable.
This study has been designed to answer some of these questions. On this study doctors will compare 2 new vaccines against the usual seasonal influenza vaccine for protectiveness using several different testing methods (including the usual tests) and for acceptability.

Start Date01 Jul 2011

Sponsor / Collaborator

University of British Columbia

NCT01346592

/ CompletedPhase 3

A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age

This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age.

Start Date01 Apr 2011

Sponsor / Collaborator-

NCT01161264

/ CompletedPhase 3

A Phase III, Multicenter, Uncontrolled, Open Label Study to Evaluate Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects

Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Following a change in the vaccine antigen composition recommendation from the previous season, immunogenicity and tolerability of the newly composed vaccines are subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects according to the guidelines set by EMEA (CPMP/BWP/214/96).

Start Date01 Jul 2010

Sponsor / Collaborator-

100 Clinical Results associated with Influenza Virus Vaccine(Seqirus)

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100 Translational Medicine associated with Influenza Virus Vaccine(Seqirus)

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100 Patents (Medical) associated with Influenza Virus Vaccine(Seqirus)

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2

Literatures (Medical) associated with Influenza Virus Vaccine(Seqirus)

01 Jul 2020·VaccineQ3 · MEDICINE

Safety and immunogenicity of three seasonal inactivated influenza vaccines among pregnant women and antibody persistence in their infants

Q3 · MEDICINE

Article

Author: Frey, Sharon E ; Munoz, Flor M ; Petrie, Carey R ; Jackson, Lisa A ; Edwards, Kathryn M ; Patel, Shital M ; Swamy, Geeta K ; Sendra, Eli A ; Keitel, Wendy A

OBJECTIVEInactivated influenza virus vaccines (IIVs) are recommended for all pregnant women in the United States. We conducted a prospective, randomized, double blind study of three licensed seasonal trivalent IIVs (IIV3s) to assess their safety and immunogenicity in pregnant women and determine the level and persistence of passively transferred maternal antibody in infants.STUDY DESIGN139 pregnant women ages 18-39 years and 14-33 weeks' gestation, and 44 non-pregnant women, were randomized 1:1:1 to receive a single intramuscular dose of one of three licensed IIV3s (Agriflu®, Fluzone®, or Fluarix®) prior to the 2010-2011 influenza season. Reactogenicity, adverse events (AEs) and pregnancy outcomes were documented. Serum samples for hemagglutination inhibition (HAI) and neutralization antibody assays were collected prior to and 28 and 180 days after immunization. Maternal sera and cord blood were collected at the time of delivery and sera were obtained from 44 infants at 6 weeks of age.RESULTSPregnant and non-pregnant women experienced similar frequency of injection site (92% and 86%, respectively) and systemic (95% and 87%, respectively) reactions, the majority of which were mild. There were no vaccine-associated maternal or infant serious AEs. Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women. The ratios of cord blood (infant) to maternal HAI antibody titers at delivery ranged between 1.1 and 1.7 for each of the vaccine antigens. Influenza antibody concentrations in infants were 70-40% of the birth titer by 6 weeks of age.CONCLUSIONSThe three IIV3s were well tolerated in pregnant women. Antibody responses were comparable in pregnant and non-pregnant women, and after second or third trimester vaccination. Transplacental transfer of maternal antibodies to the infant was efficient. However, antibody titers decline rapidly in the first 6 weeks of life.

01 Nov 2011·Expert Review of VaccinesQ2 · MEDICINE

The seasonal influenza vaccine Agriflu^®

Q2 · MEDICINE

Article

Author: Vajo, Zoltan

Seasonal influenza continues to have a large impact annually. Combined with pneumonia, influenza is the sixth leading cause of death in the USA, and vaccination has been the most important tool to prevent it. Agriflu(®) is an egg-derived, subunit, nonadjuvanted trivalent inactivated vaccine indicated for immunization to prevent disease caused by influenza virus subtypes A and B contained in the vaccine. Agriflu was approved in the USA by the US FDA on 27 November 2009, for those aged 18 years and older, to prevent disease caused by influenza virus subtypes A and B. Based on clinical trial evidence, Agriflu has been shown to be safe, with <1% serious adverse event rates, and immunogenic. It has been proven to be highly effective to prevent culture-confirmed influenza and, thus, is an alternative to previously licensed seasonal influenza vaccines. Besides Fluvirin(®), Agriflu is the only subunit vaccine available in the USA. Owing to the economic burden, morbidity and mortality caused by seasonal influenza, addition of new, safe and effective vaccines to the available tools, to reduce the impact of influenza, is of importance and benefit, especially in the face of the recent shortages of influenza vaccines.

100 Deals associated with Influenza Virus Vaccine(Seqirus)

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