Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier
1 other identifier
interventional
234
1 country
11
Brief Summary
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will 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 Jan 2006
11 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
First Submitted
Initial submission to the registry
November 24, 2005
CompletedFirst Posted
Study publicly available on registry
November 28, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
November 25, 2009
CompletedFebruary 14, 2014
January 1, 2014
1.2 years
November 24, 2005
October 19, 2009
January 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 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 the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
7 or 14 days post-vaccination
Study Arms (4)
Menactra® Group 1
EXPERIMENTALParticipants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination.
Menactra® Group 2
EXPERIMENTALParticipants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination.
Meningococcal Vaccine-naïve Group 3
EXPERIMENTALParticipants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
Meningococcal Vaccine-naïve Group 4
EXPERIMENTALParticipants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® 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 7 and 15 years (not yet 16 years).
- For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
- The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.
- A negative urine pregnancy test is required for menstruating female subjects.
- Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
You may not qualify if:
- Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)
- History of documented invasive meningococcal disease
- Received any other meningococcal vaccine
- Received any vaccine in the 28-day period prior to enrollment
- Received 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, psychiatric, or other organ system)
- Known or suspected impairment of immunologic function
- Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment
- Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) 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 of family history of Guillain-Barres 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 (11)
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Marietta, Georgia, 30062, United States
Unknown Facility
Baltimore, Maryland, 21201-1559, United States
Unknown Facility
Woburn, Massachusetts, 01801, United States
Unknown Facility
Bridgeton, Missouri, 63044, United States
Unknown Facility
Rochester, New York, 14620, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Sellersville, Pennsylvania, 18960, United States
Unknown Facility
Salt Lake City, Utah, 84123, 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
November 24, 2005
First Posted
November 28, 2005
Study Start
January 1, 2006
Primary Completion
March 1, 2007
Study Completion
November 1, 2007
Last Updated
February 14, 2014
Results First Posted
November 25, 2009
Record last verified: 2014-01