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Activity Number: 75 - Contributed Poster Presentations: Biometrics Section
Type: Contributed
Date/Time: Monday, August 3, 2020 : 10:00 AM to 2:00 PM
Sponsor: Biometrics Section
Abstract #309908
Title: Reactogenicity Adverse Events; Collection, Analysis and Reporting Process in Vaccine Clinical Trials
Author(s): Tulin Shekar*
Companies: Merck
Keywords: reactogenicity; adverse event; vaccine; data collection; analysis and reporting

Vaccine reactogenicity is an integral part of vaccine trials. Reactogenicity adverse events are defined as adverse events that are expected and occur soon after vaccination. These adverse events may include pain, redness, swelling or induration for injected vaccines, and systemic symptoms, such as fever, myalgia, headache, or rash. Reactogenicity events provide important information after vaccination such as help to the vaccine community, including healthcare professionals, in maintaining confidence in vaccines by promoting vaccination, setting expectations for vaccines regarding what might occur after vaccination. In this poster, we will provide technical details on how reactogenicity data is collected and analyzed. We will review CDISC Therapeutic Area Data Standards User Guide for Vaccines for data structure, and provide sample reactogenicity summaries that are available in public.

Authors who are presenting talks have a * after their name.

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