wing Vaccine Administration at 9 Months and 12 Months of Age Menactra vaccine at 9 months of age Menactra + PCV7*+ MMRV† + HepA‡ vaccines at 12 months of age
PCV7*+ MMRV†+ HepA‡ vaccines at 12 months of age
N§=998 - 1002 N§=898 - 908 N§=302 - 307
Reaction Any Grade 2 Grade 3 Any Grade 2 Grade 3 Any Grade 2 Grade 3
*
PCV7 (Prevnar®) = Pneumococcal 7-valent Conjugate Vaccine
†
MMRV (ProQuad®) = Measles, Mumps, Rubella and Varicella Virus Vaccine Live
‡
HepA (VAQTA®) = Hepatitis A Vaccine, Inactivated
§
N = The number of subjects with available data.
¶
Grade 2: cries and protests when injection site is touched, Grade 3: cries when injected limb is moved, or the movement of the injected limb is reduced.
#
Grade 2: ≥1.0 inches to <2.0 inches, Grade 3: ≥2.0 inches.
Þ
Grade 2: requires increased attention, Grade 3: inconsolable.
ß
Grade 2: 1 to 3 hours, Grade 3: >3 hours.
à
Grade 2: not interested in surroundings or did not wake up for a feed/meal, Grade 3: sleeping most of the time or difficult to wake up.
è
Grade 2: missed 1 or 2 feeds/meals completely, Grade 3: refuses ≥3 feeds/meals or refuses most feeds/meals.
ð
Grade 2: 2 to 5 episodes per 24 hours, Grade 3: ≥6 episodes per 24 hours or requiring parenteral 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
PCV7 (Prevnar®) = Pneumococcal 7-valent Conjugate Vaccine
†
MMRV (ProQuad®) = Measles, Mumps, Rubella and Varicella Virus Vaccine Live
‡
HepA (VAQTA®) = Hepatitis A Vaccine, Inactivated
§
N = The number of subjects with available data.
¶
Grade 2: cries and protests when injection site is touched, Grade 3: cries when injected limb is moved, or the movement of the injected limb is reduced.
#
Grade 2: ≥1.0 inches to <2.0 inches, Grade 3: ≥2.0 inches.
Þ
Grade 2: requires increased attention, Grade 3: inconsolable.
ß
Grade 2: 1 to 3 hours, Grade 3: >3 hours.
à
Grade 2: not interested in surroundings or did not wake up for a feed/meal, Grade 3: sleeping most of the time or difficult to wake up.
è
Grade 2: missed 1 or 2 feeds/meals completely, Grade 3: refuses ≥3 feeds/meals or refuses most feeds/meals.
ð
Grade 2: 2 to 5 episodes per 24 hours, Grade 3: ≥6 episodes per 24 hours or requiring parent |
