Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

New Data Demonstrate High Efficacy of Fluarix Tetra (Flu Vaccine) in Children

By GSK | March 7, 2018

Vaccine efficacy was highest against moderate-to-severe influenza, where the disease is associated with the greatest medical and socioeconomic burden. The study met its two primary endpoints, demonstrating 63.2% (97.5% CI: 51.8–72.3) vaccine efficacy against laboratory-confirmed moderate-to-severe influenza, and 49.8% (97.5% CI: 41.8–56.8) vaccine efficacy against influenza of any severity in children six to 35 months of age.

Data from the secondary endpoint, looking at culture-confirmed influenza due to influenza strains matching the vaccine strains, showed vaccine efficacy in this subset was even higher. Vaccine efficacy against moderate-to-severe influenza was 77.6% (97.5% CI: 64.3–86.6) and vaccine efficacy against influenza of any severity was 60.1% (97.5% CI: 49.1–69.0).

“Young children belong to one of the high-risk groups for influenza and are at particular risk of complications and severe disease, even when they are otherwise healthy. In addition, children play a major role in the dissemination of influenza in any community across the world”, said Thomas Breuer, Chief Medical Officer, GSK Vaccines. “This study is the first randomised clinical trial designed to evaluate vaccine efficacy for a Quadrivalent influenza vaccine in young children. It adds to the growing body of evidence to support universal vaccination including all children from six months of age to help prevent influenza in this age group, as well as the spread of influenza across the community.”

The study also found that IIV4 reduced the impact of influenza on healthcare utilisation and daily activities, approximately halving the likelihood of visits to a doctor, antibiotic use, parental work absence and missed day-care related to the current influenza illness. This is the first study to demonstrate the impact, in a randomised clinical trial, of influenza vaccination on the use of antibiotics.

About the study

The study was a Phase III, observer-blind, multinational clinical trial to evaluate the efficacy of IIV4 in the prevention of laboratory-confirmed influenza in children six to 35 months of age.

The study was conducted in five independent cohorts between October 2011 and December 2014, and enrolled 12,018 subjects in 13 countries from Europe, Central America and Asia during the 2011-2012 and 2012-2013 Northern Hemisphere influenza seasons, and from 2012 to 2014 during influenza seasons in subtropical countries to provide robust data on vaccine efficacy.

The two primary endpoints were vaccine efficacy against moderate-to-severe influenza or all influenza (regardless of disease severity) confirmed by reverse transcription polymerase chain reaction (RT-PCR) on nasal swabs.

The safety profile of the IIV4 was comparable with that of the non-influenza control vaccine.


Filed Under: Drug Discovery

 

Related Articles Read More >

FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
Lokavant’s Spectrum v15 uses AI to cut trial-feasibility modeling from weeks to minutes
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE