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

Phase 2

Completed

• Conditions: Meningococcal Infection; Meningitis
• Interventions: Biological: Polysaccharide Diphtheria Conjugate Vaccine

• Registration Number: NCT00258856
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-24
• Study First Submitted QC: 2005-11-24
• Study First Posted: 2005-11-28
• Study Start: 2006-01
• Primary Completion: 2007-03
• Study Completion: 2007-11
• Results First Submitted: 2009-10-19
• Results First Submitted QC: 2009-10-19
• Results First Posted: 2009-11-25
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menactra® Group 1	Polysaccharide Diphtheria Conjugate Vaccine	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.
Menactra® Group 2	Polysaccharide Diphtheria Conjugate Vaccine	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.
Meningococcal Vaccine-naïve Group 3	Polysaccharide Diphtheria Conjugate Vaccine	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.
Meningococcal Vaccine-naïve Group 4	Polysaccharide Diphtheria Conjugate Vaccine	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.

Primary Outcome Measures

Name	Time	Method
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.	7 or 14 days post-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.