Status:
COMPLETED
Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcal Infection
Eligibility:
All Genders
15-23 years
Phase:
PHASE2
Brief Summary
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00269477
Start Date
December 1 2005
End Date
December 1 2007
Last Update
April 14 2016
Active Locations (8)
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1
Atlanta, Georgia, United States, 30322
2
Marietta, Georgia, United States, 30062
3
Woburn, Massachusetts, United States, 01801
4
Akron, Ohio, United States, 44308