Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®
Persistence of Bactericidal Antibodies in Adolescents and Adults Aged 15 to 23 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier
1 other identifier
interventional
145
1 country
8
Brief Summary
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2005
8 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, 2005
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
December 14, 2009
CompletedApril 14, 2016
April 1, 2016
1.2 years
December 22, 2005
November 10, 2009
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.
Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.
28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)
Other Outcomes (1)
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions
Day 0 to 7 post-vaccination
Study Arms (4)
Menactra® Vaccine Group 1
EXPERIMENTALParticipants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Menactra® Vaccine Group 2
EXPERIMENTALParticipants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination
Meningococcal Vaccine-naive Group 3
ACTIVE COMPARATORParticipants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Meningococcal Vaccine-naive Group 4
ACTIVE COMPARATORParticipants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Interventions
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Subject is healthy, as determined by medical history.
- Subject is between the ages of 15 and 23 years (not yet 24 years).
- For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
- Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study)
- Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
- Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications
- A negative urine pregnancy test is required for menstruating female subjects.
You may not qualify if:
- History of documented invasive meningococcal disease.
- Received any other meningococcal vaccine
- Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment
- Scheduled to receive any vaccination in the 28-day period after enrollment
- Received systemic antibiotic therapy within the 72 hours prior to collection of a blood sample
- Actively enrolled or scheduled to be enrolled in another clinical study
- Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, hematologic, psychiatric, or other organ system)
- Known or suspected impairment of immunologic function
- Administration of immune globulin, other blood products, or corticosteroid within 3 months of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
- Personal or family history of Guillain-Barre Syndrome
- Suspected or known hypersensitivity to any of the vaccine components
- Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
- Any condition, which in the opinion of the investigator would pose a health risk to the participant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Marietta, Georgia, 30062, United States
Unknown Facility
Woburn, Massachusetts, 01801, United States
Unknown Facility
Akron, Ohio, 44308, United States
Unknown Facility
Columbus, Ohio, 43205, United States
Unknown Facility
Sellersville, Pennsylvania, 18960, United States
Unknown Facility
Kingsport, Tennessee, 37660, United States
Unknown Facility
Norfolk, Virginia, 23510, 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 Monitor
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 23, 2005
Study Start
December 1, 2005
Primary Completion
February 1, 2007
Study Completion
December 1, 2007
Last Updated
April 14, 2016
Results First Posted
December 14, 2009
Record last verified: 2016-04