TABLE 6-1 Ad Hoc Studies of Immediate-Onset Adverse Events Following Anthrax Vaccination: Local Events

Study

Study Population and Observation Period

Data Collection Method(s)

Number of Subjects or Doses

Randomized Controlled Trials

Field study (Brachman et al., 1962)b

U.S. goat hair mill workers (4 mills), 1955–1959

Examination at 24 and 48 hours (2 mills)

1,249 persons (4 mills)

Placebo

 

Route of administration pilot study (Pittman, 2001b; Pittman et al., 2002)c

Military and civilian study volunteers, 1998

Active surveillance

173 persons; 117 with all doses

Intramuscular

 

118 doses

Subcutaneous

 

203 doses

Subcutaneous

Men

 

132 doses

Subcutaneous

Women

 

71 doses

Other Controlled Studies

Double dose (Gunzenhauser et al., 2001)

ROTC cadets, Ft. Lewis, summer 2000

Self-report; postvaccination survey

73 cadets

Doubled first dosee

 

25

Standard dosese

 

48



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