Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier
1 other identifier
observational
763
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2008
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 13, 2009
CompletedFirst Posted
Study publicly available on registry
March 16, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
January 13, 2011
CompletedApril 14, 2016
April 1, 2016
3 months
March 13, 2009
December 11, 2010
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Day 0
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Day 0
Study Arms (3)
Group 1: Menactra® from Previous Studies
Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21.
Group 2: Menomune® from Previous Study
Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04
Group 3: Control
Meningococcal vaccine-naive age matched subjects
Interventions
Eligibility Criteria
Subjects that previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257); or Menomune® in Study MTA04 and age-matched meningococcal vaccine-naive controls.
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:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
Marietta, Georgia, 30062, United States
Unknown Facility
Martinez, Georgia, 30907, United States
Unknown Facility
Woodstock, Georgia, 30189, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Austintown, Ohio, 44515, United States
Unknown Facility
Cleveland, Ohio, 44121, United States
Unknown Facility
Erie, Pennsylvania, 16505, United States
Unknown Facility
Greenville, Pennsylvania, 16125, United States
Unknown Facility
Harleysville, Pennsylvania, 19438, United States
Unknown Facility
Latrobe, Pennsylvania, 15650, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15236, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Sellersville, Pennsylvania, 18960, United States
Unknown Facility
Wexford, Pennsylvania, 15090, United States
Unknown Facility
Kingsport, Tennessee, 37660, United States
Unknown Facility
Spokane, Washington, 99202, United States
Unknown Facility
Spokane, Washington, 99218, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2009
First Posted
March 16, 2009
Study Start
December 1, 2008
Primary Completion
March 1, 2009
Study Completion
December 1, 2009
Last Updated
April 14, 2016
Results First Posted
January 13, 2011
Record last verified: 2016-04