Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meningitis, Meningococcal Infection

Intervention / Treatment
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* Biological: Polysaccharide Diphtheria Conjugate Vaccine
* Biological: Polysaccharide Diphtheria Conjugate Vaccine
* Biological: Polysaccharide Diphtheria Conjugate Vaccine
* Biological: Polysaccharide Diphtheria Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 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 1<br>Participants 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. | Biological: Polysaccharide Diphtheria Conjugate Vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Experimental: Menactra® Group 2<br>Participants 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. | Biological: Polysaccharide Diphtheria Conjugate Vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Experimental: Meningococcal Vaccine-naïve Group 3<br>Participants 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. | Biological: Polysaccharide Diphtheria Conjugate Vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Experimental: Meningococcal Vaccine-naïve Group 4<br>Participants 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. | Biological: Polysaccharide Diphtheria Conjugate Vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Meningococcal infection, Neisseria meningitidis, Menactra®, Menomune®