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Phase 2 N=241 Prevention

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

Meningitis · Meningococcemia

Enrolled (actual)
241
Serious AEs
0.0%
Results posted
Mar 2009
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. — 1075.2; 193.6; 83.3; 9300.5 Titer

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
Age
Pediatric, Adult · 13+ yrs
Sex
All
Sponsor
Sanofi Pasteur, a Sanofi Company
Primary completion
Apr 2004

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
1075.2; 193.6; 83.3; 9300.5; 4423.9; 12897.1

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00777790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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