Application of a Historical Control Database to Characterize Adverse Events in a Vaccine-Eligible Population

• Activity Number: 160
• Type: Invited
• Date/Time: Monday, August 10, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Prakash Bhuyan*
• Companies: Pfizer Inc.
• Keywords: drug development ; safety ; data analysis ; historic controls

Abstract

Background:Safety evaluation for drug development requires contextual information to distinguish between expected and unexpected adverse events. A historical clinical trial database, eControls, was adapted to eligibility requirements of clinical studies of prophylactic vaccines for healthy adults to estimate the background incidence of adverse events for a healthy, vaccine-eligible, adult population. Methods:Clinical data sources were integrated from 42 completed studies (45,291 subjects). Subjects were excluded if they had conditions that would have prevented participation in typical prophylactic vaccine studies. Adverse event incidence rates were calculated as observed during the treatment period (?6 weeks). A placebo subset was explored as an indicator of potential bias. Results:The most frequent adverse event term was headache (4.77%). Allergy-related events, urticaria and anaphylaxis occurred at 7 and 0.08 events per 1000-subject years, respectively. Conclusions:This application illustrates the utility of historic clinical trial data to estimate the incidence of adverse events in clinical study settings to provide context for the interpretation of product safety.