Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT00777257
Eligibility Criteria:
Inclusion Criteria :
* Healthy as determined by medical history and physical examination.
* Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
* Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
* Informed assent form that has been approved by the IRB signed by the subject.
* Subject (female) agrees to use measures to prevent pregnancy during the study.
Exclusion Criteria :
* Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
* Known or suspected impairment of immunologic function.
* Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
* Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \<7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.
* Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.
* Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
* Suspected or known hypersensitivity to either of the two study vaccines or their components.
* Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
* Enrolled in another clinical trial.
* Diagnosed with any condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
* Nursing mothers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
17 Years
Study:
NCT00777257
Study Brief:
Protocol Section:
NCT00777257