Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

Completed

Conditions studied: Meningococcal Infections, Meningitis

In brief

To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier

Key facts

Study ID

NCT00862277

Run by

Sanofi Pasteur, a Sanofi Company

People needed

763

Starts

2008-12-01

Expected to finish

2009-12-01

Last updated by the study team

2016-04-14

Who can join

Age: 14 and older, up to 27. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Fountain Valley, California, United States
• Study site — Marietta, Georgia, United States
• Study site — Martinez, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Omaha, Nebraska, United States
• Study site — Austintown, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Erie, Pennsylvania, United States
• Study site — Greenville, Pennsylvania, United States
• Study site — Harleysville, Pennsylvania, United States
• Study site — Latrobe, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Sellersville, Pennsylvania, United States
• Study site — Wexford, Pennsylvania, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Spokane, Washington, United States
• Study site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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