The project compared adverse event reporting rates for Lederle's DTP and DTPH vaccines. Fourteen lots of DTPH vaccines and 14 contemporaneous lots of DTP were selected. Adverse Event REports (VAERS reports) reporting rates were calculated for 20 categories of adverse events, including the categories of all serious and death events. Significant elevations of reporting rates for DTPH vaccine were found for many categories of events including all events and serious events. """"""""Relative risks"""""""" were between 1.5 and 2.5 (DTPH/DTP) and p values ranged down to 10-4.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Intramural Research (Z01)
Project #
1Z01BS002005-01
Application #
5200891
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
1995
Total Cost
Indirect Cost
Name
Division of Biologics Standards
Department
Type
DUNS #
City
State
Country
United States
Zip Code