Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine. Immunogenicity: To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
216
0.5 mL, Subcutaneous
0.5 mL, Intramuscular
0.5 mL. Intramuscular
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Bardstown, Kentucky, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
West Jordon, Utah, United States
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Time frame: 0-7 days post-vaccination 1
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Solicited injection site reactions: Pain, Erythema, and Swelling.
Time frame: 0-7 Days Post-vaccination 2
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Time frame: Day 0 to 7 Post-vaccination 2
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0.5 mL, Intramuscular
Unnamed facility
Seattle, Washington, United States
Unnamed facility
Spokane, Washington, United States