Status:
COMPLETED
Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningococcal Infections
Meningitis
Eligibility:
All Genders
14-27 years
Brief Summary
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
763 Patients enrolled
Trial Details
Trial ID
NCT00862277
Start Date
December 1 2008
End Date
December 1 2009
Last Update
April 14 2016
Active Locations (20)
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1
Little Rock, Arkansas, United States, 72205
2
Fountain Valley, California, United States, 92708
3
Marietta, Georgia, United States, 30062
4
Martinez, Georgia, United States, 30907