Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
Age
15–23
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Subject is healthy, as determined by medical history.
Subject is between the ages of 15 and 23 years (not yet 24 years).
For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study)
Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications
A negative urine pregnancy test is required for menstruating female subjects.
You may not be if
History of documented invasive meningococcal disease.
Received any other meningococcal vaccine
Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment
Scheduled to receive any vaccination in the 28-day period after enrollment
Received systemic antibiotic therapy within the 72 hours prior to collection of a blood sample
Actively enrolled or scheduled to be enrolled in another clinical study
Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, hematologic, psychiatric, or other organ system)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion
Administration of immune globulin, other blood products, or corticosteroid within 3 months of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Personal or family history of Guillain-Barre Syndrome
Suspected or known hypersensitivity to any of the vaccine components
Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
Any condition, which in the opinion of the investigator would pose a health risk to the participant.
