Performance Improvement 1995. Food and Drug Administration

02/01/1995

Listing of Abstract Titles

Evaluation of Influenza Virus Vaccine in High Risk Infection Categories

Increasing the Safety of the Blood Supply by Screening Donors More Effectively

TITLE: Evaluation of Influenza Virus Vaccine in High Risk Infection Categories

ABSTRACT NUMBER: 019

ABSTRACT: The objective of this study was to ensure the continued protection of the public from the influenza virus through ongoing investigation into the reactogenicity, immunogenicity, and protective efficiency of split product and whole virus influenza vaccines and other vaccines that are commercially available or being considered for licensure. Information from the study is helping scientific reviewers assess current vaccines, while providing guidance to developing vaccines for licensure in the Center for Biologics Evaluation and Research. The sera obtained during this study are being used to provide standard sets of sera so that results from different national and international reference laboratories can verify comparability of results. The studies in infants are reproduced by no other source and serve as an important reference resource.

FEDERAL CONTACT OFFICE: Office of Program Planning and Evaluation

PERSON: Tim Hagerty

PHONE NUMBER: 301/443-4076

PIC NUMBER: 4355

PERFORMER ORGANIZATION: Hackensack Medical Center, Hackensack, NJ

P.I.: Peter Gross

TITLE: Increasing the Safety of the Blood Supply by Screening Donors More Effectively

ABSTRACT NUMBER: 020

ABSTRACT: The goal of the study was to improve the blood donation process by integrating and simplifying all information (particularly HIV/AIDS-related information) presented to donors. The study evaluated mechanisms for blood donor education that address the needs of first-time donors and blood center staff. The study findings are helping the Center for Biologics Evaluation and Research staff screen out unsuitable donors and motivate healthy ones to donate more frequently. As a result of this study, a new donor screening process and a training program for health screeners were developed.

FEDERAL CONTACT OFFICE: Office of Program Planning and Evaluation

PERSON: Tim Hagerty

PHONE NUMBER: 301/443-4076

PIC NUMBER: 5685

PERFORMER ORGANIZATION: American Institutes for Research, Washington, DC

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