eral hydration.
ø
Grade 2: >38.5°C to ≤39.5°C, Grade 3: >39.5°C.
Local/Injection Site
Tenderness¶
Menactra Site 37.4 4.3 0.6 48.5 7.5 1.3 - - -
PCV7 Site - - - 45.6 9.4 1.6 45.7 8.3 0.3
MMRV Site - - - 38.9 7.1 1.0 43.0 5.2 0.0
HepA Site - - - 43.4 8.7 1.4 40.9 4.6 0.3
Erythema#
Menactra Site 30.2 2.5 0.3 30.1 1.3 0.1 - - -
PCV7 Site - - - 29.4 2.6 0.2 32.6 3.0 0.7
MMRV Site - - - 22.5 0.9 0.3 33.2 5.9 0.0
HepA Site - - - 25.1 1.1 0.0 26.6 0.7 0.0
Swelling#
Menactra Site 16.8 0.9 0.2 16.2 0.9 0.1 - - -
PCV7 Site - - - 19.5 1.3 0.4 16.6 1.3 0.7
MMRV Site - - - 12.1 0.4 0.1 14.1 0.3 0.0
HepA Site - - -` 16.4 0.7 0.2 13.5 0.0 0.3
Systemic
IrritabilityÞ 56.8 23.1 2.9 62.1 25.7 3.7 64.8 28.7 4.2
Abnormal cryingß 33.3 8.3 2.0 40.0 11.5 2.4 39.4 10.1 0.7
Drowsinessà 30.2 3.5 0.7 39.8 5.3 1.1 39.1 5.2 0.7
Appetite lossè 30.2 7.1 1.2 35.7 7.6 2.6 31.9 6.5 0.7
Vomitingð 14.1 4.6 0.3 11.0 4.4 0.2 9.8 2.0 0.0
Feverø 12.2 4.5 1.1 24.5 11.9 2.2 21.8 7.3 2.6
Table 2: Percentage of US Participants 2 Years Through 10 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration Menactra vaccine Menomune – A/C/Y/W-135 vaccine
N*=1156 - 1157 N*=1027
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 total number of subjects reporting at least one solicited reaction. The median age of participants was 6 years in both vaccine groups.
†
Grade 2: interferes with normal activities, Grade 3: disabling, unwilling to move arm.
‡
Grade 2: 1.0-2.0 inches, Grade 3: >2.0 inches.
§
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 - -
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.
*
N = The total number of subjects reporting at least one solicited reaction. The median age of participants was 6 years in both vaccine groups.
†
Grade 2: interferes with normal activities, Grade 3: disabling, unwilling to move arm.
‡
Grade 2: 1.0-2.0 inches, Grade 3: >2.0 inches.
§
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