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. Author manuscript; available in PMC: 2011 Aug 31.

Published in final edited form as: Vaccine. 2010 Jul 7;28(38):6367–6373. doi: 10.1016/j.vaccine.2010.06.084

A. Percent of Subjects with Maximum Local Reactogenicity by Dose and Vaccination. Reactogenicity data was summarized as maximum severity for each symptom after each vaccination. The most common solicited reaction is pain/tenderness at the injections site. A similar number of moderate events followed each vaccination. Severe reactions occurred in subjects receiving the 20 μg dose following the third vaccination. The proportion of subjects experiencing mild or greater severity of reactogenicity is not associated with assigned dosage level (p < 0.05, exact test).

B. Maximum Systemic Reactogenicity by Dose and Vaccination. Systemic reactogenicity data was solicited for 15 days (Study days 0–14) after each vaccination and was recorded on a diary card. Subjects graded reactogenicity as mild, moderate or severe. Mild was defined as awareness of symptom but easily tolerated and did not keep the subject from normal, daily activities; moderate was defined as the subject acting like something was wrong and resulted in some limitation in the subject’s normal daily activities; and severe was defined as being extremely distressed or unable to do normal daily activities. Reactogenicity was summarized as maximum severity for each symptom after each vaccination. A similar number of moderate events followed each vaccination. Severe reactions occurred in subjects receiving the 20 μg dose following the second and third vaccinations. The proportion of subjects experiencing mild or greater severity of reactogenicity is not associated with assigned dosage level (p < 0.05, exact test).

A. Percent of Subjects with Maximum Local Reactogenicity by Dose and Vaccination. Reactogenicity data was summarized as maximum severity for each symptom after each vaccination. The most common solicited reaction is pain/tenderness at the injections site. A similar number of moderate events followed each vaccination. Severe reactions occurred in subjects receiving the 20 μg dose following the third vaccination. The proportion of subjects experiencing mild or greater severity of reactogenicity is not associated with assigned dosage level (p < 0.05, exact test).

B. Maximum Systemic Reactogenicity by Dose and Vaccination. Systemic reactogenicity data was solicited for 15 days (Study days 0–14) after each vaccination and was recorded on a diary card. Subjects graded reactogenicity as mild, moderate or severe. Mild was defined as awareness of symptom but easily tolerated and did not keep the subject from normal, daily activities; moderate was defined as the subject acting like something was wrong and resulted in some limitation in the subject’s normal daily activities; and severe was defined as being extremely distressed or unable to do normal daily activities. Reactogenicity was summarized as maximum severity for each symptom after each vaccination. A similar number of moderate events followed each vaccination. Severe reactions occurred in subjects receiving the 20 μg dose following the second and third vaccinations. The proportion of subjects experiencing mild or greater severity of reactogenicity is not associated with assigned dosage level (p < 0.05, exact test).