Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents

Study Overview
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Brief Summary
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This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02. Primary Objective: To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.

Detailed Description
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All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.

Official Title
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Antibody Responses to a Booster Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, Menactra® in Adolescents Who Previously Received Menomune® or Menactra®

Conditions
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Meningitis, Meningococcemia

Intervention / Treatment
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* Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
* Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
* Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Participant is healthy, as determined by medical history and physical examination. Participant is at least 13 years of age but not yet 22 years of age at time of enrollment. For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up). For the Control group, participant has no previous history of any meningococcal vaccination. If < 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-approved informed consent form. If ≥ 18 years of age, participant has signed an IRB-approved informed consent form. Able to provide vaccination log. 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 oral temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of inclusion. For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial. For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination. 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 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination. 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. In females, a positive or equivocal urine pregnancy test at the time of vaccination. 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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menactra® Group<br>Received Menactra® vaccine in Study MTA02 | Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Experimental: Menomune® Group<br>Received Menomune® vaccine in Study MTA02 | Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Experimental: Control Group<br>Meningococcal vaccine-naïve Control Group. | Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Mneactra®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group. | Day 0 and 8 and 28 days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Meningococcemia, Neisseria meningitidis