- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00772070
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arkansas
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Jonesboro, Arkansas, United States, 72401
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Little Rock, Arkansas, United States, 72211
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Massachusetts
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Woburn, Massachusetts, United States, 01801
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Missouri
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Bridgeton, Missouri, United States, 63044
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New York
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Rochester, New York, United States, 14620
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15241
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Sellersville, Pennsylvania, United States, 18960
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Virginia
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Norfolk, Virginia, United States, 23501
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria :
- 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.
Exclusion Criteria :
- Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc.)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature (≥ 99.5ºF [≥ 37.5ºC]) at the time of inclusion
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Previously received TetraMenD
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
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0.05 mL, Subcutaneous
Other Names:
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Experimental: Meningococcal vaccine-naїve
Participants have never received a Meningococcal vaccine in the past.
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0.05 mL, Subcutaneous
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Time Frame: Day 0 and Days 8 and 28 post-vaccination
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Day 0 and Days 8 and 28 post-vaccination
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Time Frame: Baseline to Day 8 and Day 28 post-vaccination
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Baseline to Day 8 and Day 28 post-vaccination
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Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Time Frame: Day 0 to 7 post-vaccination
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Day 0 to 7 post-vaccination
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTA17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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