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

Sanofi

Status

Completed

Conditions

Meningitis

Meningococcal Infections

Treatments

Biological: Menomune®

Biological: Menactra®

Study type

Observational

Funder types

Industry

Identifiers

NCT00862277

MTA64

Details and patient eligibility

About

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

Full description

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.

Enrollment

763 patients

Sex

All

Ages

14 to 27 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)