.7‡ 2.1‡ 0.6‡ 5.6 1.0 0.0
Vomitingß 2.3 0.4 0.2 1.5 0.2 0.4
Feverà 1.5‡ 0.3 0.0 0.5 0.1 0.0
Rashè 1.4 - - 0.8 - -
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 number of subjects with available data.
†
Grade 2: interferes with or limits usual arm movement, Grade 3: disabling, unable to move arm.
‡
Denotes p <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
Grade 2: 2 episodes, Grade 3: ≥3 episodes.
à
Oral equivalent temperature; Grade 2: 39.0°C to 39.9ºC, Grade 3: ≥40.0ºC.
è
These solicited adverse events were reported as present or absent only.
Local/Injection Site
Pain† 53.9‡ 11.3‡ 0.2 48.1 3.3 0.1
Induration§ 17.1‡ 3.4‡ 0.7‡ 11.0 1.0 0.0
Redness§ 14.4 2.9 1.1‡ 16.0 1.9 0.1
Swelling§ 12.6‡ 2.3‡ 0.9‡ 7.6 0.7 0.0
Systemic
Headache¶ 41.4 10.1 1.2 41.8 8.9 0.9
Fatigue¶ 34.7 8.3 0.9 32.3 6.6 0.4
Malaise ¶ 23.6 6.6‡ 1.1 22.3 4.7 0.9
Arthralgia¶ 19.8‡ 4.7‡ 0.3 16.0 2.6 0.1
Diarrhea# 16.0 2.6 0.4 14.0 2.9 0.3
AnorexiaÞ 11.8 2.3 0.4 9.9 1.6 0.4
Chills¶ 9.7‡ 2.1‡ 0.6‡ 5.6 1.0 0.0
Vomitingß 2.3 0.4 0.2 1.5 0.2 0.4
Feverà 1.5‡ 0.3 0.0 0.5 0.1 0.0
Rashè 1.4 - - 0.8 - -
Seizureè 0.0 - - 0.0 - -
Adverse Events in Concomitant Vaccine Studies
Solicited Injection site and Systemic Reactions when Given with Routine Pediatric Vaccines
For a description of the study design and number of participants [see Clinical Studies, Concomitant Vaccine Administration (14.3)]. In the primary safety study, 1378 U.S. children were enrolled to receive Menactra vaccine alone at 9 months of age and Menactra vaccine plus one or more other routinely administered vaccines (MMRV, PCV7 and HepA) at 12 months of age (N=961). Another group of children received two or more routinely administered vaccines (MMRV, PCV7 and HepA vaccines) (control group, n=321) at 12 months of age. The frequency of occurrence of solicited adverse events is presented in Table 1. Participants who received Menactra vaccine and the concomitant vaccines at 12 months of age described above reported similar frequencies of tenderness, redness and swelling at the Menactra vaccine injection site and at the concomitant vaccine injection sites. Tenderness was the most frequent injection site reaction (48%, 39%, 46% and 43% at the Menactra vaccine, MMRV, PCV7 and HepA vaccine sites, respectively). Irritability was the most frequent systemic reaction, reported in 62% of recipients of Menactra vaccine plus concomitant vaccines, and 65% of control group. [See Concomitant Vaccine Administration (14.3)].
Solicited Injection site and Systemic Reactions when Given with Tetanus and Diphtheria Toxoid Adsorbed Vaccine
In a clinical study, rates of local and systemic reactions aft
