This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,378
0.5 mL, IM at age 9 and 12 months
0.5 mL, intramuscular at 12 months of age
0.5 mL, Intramuscular at age 12 months
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability
Time frame: Day 0 to 7 Post-vaccination
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0.5 mL, Intramuscular at age 12 months
Unnamed facility
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Pinson, Alabama, United States
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Tuscaloosa, Alabama, United States
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Chandler, Arizona, United States
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Bentonville, Arkansas, United States
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Conway, Arkansas, United States
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Hardy, Arkansas, United States
Unnamed facility
Jonesboro, Arkansas, United States
...and 69 more locations