Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 14 - 27 |
Updated: | 4/21/2016 |
Start Date: | December 2008 |
End Date: | December 2009 |
Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier
To evaluate the persistence of bactericidal antibodies in adolescents and adults who
received one dose of Menactra® vaccine approximately four to eight years earlier
received one dose of Menactra® vaccine approximately four to eight years earlier
Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19
(NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study.
All eligible subjects will provide a blood sample at Visit 1, after which their
participation in the study will be terminated. An age-matched meningococcal-vaccine naïve
control group will be recruited to provide a blood sample for baseline antibody level
evaluation.
No vaccine will be administered in this study.
(NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study.
All eligible subjects will provide a blood sample at Visit 1, after which their
participation in the study will be terminated. An age-matched meningococcal-vaccine naïve
control group will be recruited to provide a blood sample for baseline antibody level
evaluation.
No vaccine will be administered in this study.
Inclusion Criteria :
- For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject
- For subjects aged < 18 years: Informed consent form signed and dated by the subject
and the subject's parent/legal guardian
- Subject (and parent/legal guardian if subject is < 18 years of age) able to attend
the scheduled visit and comply with all trial procedures
- For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®,
received in Study MTA04, MTA12, MTA19, or MTA21)
- For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®,
received in Study MTA04)
- For Group 3: Aged 14 through 27 years and never received any meningococcal vaccine
Exclusion Criteria :
- Participation in another clinical trial investigating a vaccine, drug, medical
device, or a medical procedure in the 4 weeks preceding inclusion
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
or long-term systemic corticosteroids therapy > 2 weeks
- Chronic illness at a stage that could interfere with trial conduct or completion, in
the opinion of the investigator
- Current alcohol abuse or drug addiction that may interfere with the subject's ability
to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months that might interfere
with the assessment of immune responses
- Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity
- History of invasive meningococcal disease (confirmed either clinically,
serologically, or microbiologically)
- For Groups 1 and 2: Previous vaccination (including booster) against meningococcal
disease, with the exception of the Menactra® or Menomune® vaccination received in
trial MTA04, MTA12, MTA19, or MTA21
- Subjects deprived of freedom by an administrative or court order, or in an emergency
setting, or hospitalized without his/her consent
- Received oral or injected antibiotic therapy within the 72 hours prior to the blood
draw (temporary criteria)
We found this trial at
18
sites
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