We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Novavax RSV Vaccine Flops in Phase III Primary Endpoint

Novavax RSV Vaccine Flops in Phase III Primary Endpoint

September 26, 2016

Novavax’s respiratory syncytial virus failed to meet its Phase III trial endpoints, and did not demonstrate efficacy compared to placebo. The trial of the RSV F Vaccine enrolled 11,856 adults, 60 years of age and older, at 60 sites in the U.S.

The trial did not demonstrate prevention of moderate-severe RSV-associated lower respiratory tract disease, nor did it meet its secondary objective of reducing the incidence of all symptomatic respiratory disease due to RSV.

The attack rate for the primary objective was approximately 25 percent of that observed in a previous Phase II trial, according to the company. Novavax expects to have preliminary immunogenicity data in the coming weeks.

View today's stories

Pharmaceuticals Research and Development

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • UKflag.jpg

    UK Study Says Single Shot of Pfizer/BioNTech Vaccine Significantly Lessened Asymptomatic Infections

  • emergency use authorization approved

    Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test

  • FDA clears text

    Vetex Medical’s Thrombectomy Catheter Cleared by FDA

  • 100Bills_flatmoney.gif

    Merck Purchases Rights to Debiopharm’s Xevinapant for More Than $1 Billion

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing