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

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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

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.

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
Sellersville, Pennsylvania 18960
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Sellersville, PA
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Austintown, OH
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Bardstown, KY
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Cleveland, OH
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Erie, PA
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Fountain Valley, California 92708
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Fountain Valley, CA
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Greenville, PA
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Harleysville, PA
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Kingsport, TN
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Latrobe, PA
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Little Rock, AR
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Marietta, GA
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Martinez, GA
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Omaha, NE
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Pittsburgh, PA
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Spokane, WA
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Wexford, PA
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Woodstock, GA
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