Grade 2: 1-3 hours duration, Grade 3: >3 hours duration.
¶
Grade 2: 3-4 episodes, Grade 3: ≥5 episodes.
#
Grade 2: interferes with normal activities, Grade 3: disabling, unwilling to engage in play or interact with others.
Þ
Grade 2: skipped 2 meals, Grade 3: skipped ≥3 meals.
ß
Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unable to move major joints due to pain.
à
Oral equivalent temperature; Grade 2: 38.4°C to 39.4ºC, Grade 3: ≥39.5ºC.
è
These solicited adverse events were reported as present or absent only.
ð
Grade 2: 2 episodes, Grade 3: ≥3 episodes.
Local/Injection Site
Pain† 45.0 4.9 0.3 26.1 2.5 0.0
Redness‡ 21.8 4.6 3.9 7.9 0.5 0.0
Induration‡ 18.9 3.4 1.4 4.2 0.6 0.0
Swelling‡ 17.4 3.9 1.9 2.8 0.3 0.0
Systemic
Irritability§ 12.4 3.0 0.3 12.2 2.6 0.6
Diarrhea¶ 11.1 2.1 0.2 11.8 2.5 0.3
Drowsiness# 10.8 2.7 0.3 11.2 2.5 0.5
AnorexiaÞ 8.2 1.7 0.4 8.7 1.3 0.8
Arthralgiaß 6.8 0.5 0.2 5.3 0.7 0.0
Feverà 5.2 1.7 0.3 5.2 1.7 0.2
Rashè 3.4 - - 3.0 - -
Vomitingð 3.0 0.7 0.3 2.7 0.7 0.6
Seizureè 0.0 - - 0.0 - -
Table 3: Percentage of Participants 11 Years Through 18 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration Menactra vaccine Menomune – A/C/Y/W-135 vaccine
N*=2264 - 2265 N*=970
Reaction Any Grade 2 Grade 3 Any Grade 2 Grade 3
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.
*
N = The number of subjects with available data.
†
Grade 2: interferes with or limits usual arm movement, Grade 3: disabling, unable to move arm.
‡
Denotes ρ <0.05 level of significance. The p values were calculated for each category and severity using Chi Square test.
§
Grade 2: 1.0-2.0 inches, Grade 3: >2.0 inches.
¶
Grade 2: interferes with normal activities, Grade 3: requiring bed rest.
#
Grade 2: 3-4 episodes, Grade 3: ≥5 episodes.
Þ
Grade 2: skipped 2 meals, Grade 3: skipped ≥3 meals.
ß
Oral equivalent temperature; Grade 2: 38.5°C to 39.4ºC, Grade 3: ≥39.5ºC.
à
Grade 2: 2 episodes, Grade 3: ≥3 episodes.
è
These solicited adverse events were reported as present or absent only.
Local/Injection Site
Pain† 59.2‡ 12.8‡ 0.3 28.7 2.6 0.0
Induration§ 15.7‡ 2.5‡ 0.3 5.2 0.5 0.0
Redness§ 10.9‡ 1.6‡ 0.6‡ 5.7 0.4 0.0
Swelling§ 10.8‡ 1.9‡ 0.5‡ 3.6 0.3 0.0
Systemic
Headache¶ 35.6‡ 9.6‡ 1.1 29.3 6.5 0.4
Fatigue¶ 30.0‡ 7.5 1.1‡ 25.1 6.2 0.2
Malaise¶ 21.9‡ 5.8‡ 1.1 16.8 3.4 0.4
Arthralgia¶ 17.4‡ 3.6‡ 0.4 10.2 2.1 0.1
Diarrhea# 12.0 1.6 0.3 10.2 1.3 0.0
AnorexiaÞ 10.7‡ 2.0 0.3 7.7 1.1 0.2
Chills¶ 7.0‡ 1.7‡ 0.2 3.5 0.4 0.1
Feverß 5.1 ‡ 0.6 0.0 3.0 0.3 0.1
Vomitingà 1.9 0.4 0.3 1.4 0.5 0.3
Rashè 1.6 - - 1.4 - -
Seizureè 0.0 - - 0.0 - -
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.
*
N = The num |
