Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD
1 other identifier
interventional
173
1 country
8
Brief Summary
This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier. Primary Objective: To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal 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 Mar 2003
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 13, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedResults Posted
Study results publicly available
May 14, 2009
CompletedFebruary 14, 2014
January 1, 2014
5 months
October 13, 2008
March 26, 2009
January 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Day 0 and Days 8 and 28 post-vaccination
Other Outcomes (2)
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Baseline to Day 8 and Day 28 post-vaccination
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Day 0 to 7 post-vaccination
Study Arms (2)
Previously received TetraMenD
EXPERIMENTALParticipants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
Meningococcal vaccine-naїve
EXPERIMENTALParticipants have never received a Meningococcal vaccine in the past.
Interventions
0.05 mL, Subcutaneous
Eligibility Criteria
You may qualify if:
- Stage I
- Participant is healthy, as determined by medical history and physical examination.
- Participant is at least 3 years of age but not yet 6 years of age at the enrolment.
- For the TetraMenD group: received one dose of TetraMenD as a participant in trial 603-02 no less than 18 months prior to enrolment
- For the Control group: no previous history of any meningococcal vaccination
- Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
- Stage II
- Participant is healthy, as determined by medical history and physical examination.
- Participant is at least 3 years of age but not yet 6 years of age at the time of enrollment in Stage 1.
- Enrolled in the Control group only and received one dose of the reduced dose Menomune at Stage 1.
- Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
You may not qualify if:
- Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc.)
- Known or suspected impairment of immunologic function
- For Stage I, history of documented invasive meningococcal disease or previous meningococcal vaccination with exception of those participants recruited from Trial 603-02.
- For Stage II, history of documented invasive meningococcal disease or participant did not receive Reduced-dose Menomune® six months prior.
- Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks 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.
- Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn
- Received any vaccine in the 28-day period prior to study vaccination, or scheduled to receive any vaccination during the 28-day period after study vaccination in Stage 1 of the trial.
- 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
- Enrolled in another clinical trial
- Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Little Rock, Arkansas, 72211, 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
Norfolk, Virginia, 23501, United States
Related Publications (1)
Pichichero M, Papa T, Blatter M, Mitchell D, Kratz R, Sneed J, Bassily E, Casey J, Gilmet G. Immune memory in children previously vaccinated with an experimental quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine. Pediatr Infect Dis J. 2006 Nov;25(11):995-1000. doi: 10.1097/01.inf.0000243215.46312.4a.
PMID: 17072120RESULT
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
October 13, 2008
First Posted
October 15, 2008
Study Start
March 1, 2003
Primary Completion
August 1, 2003
Study Completion
May 1, 2004
Last Updated
February 14, 2014
Results First Posted
May 14, 2009
Record last verified: 2014-01