Phase 2
N=241
Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
Meningitis · Meningococcemia
Bottom Line
View on ClinicalTrials.gov: NCT00777790 ↗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
| Outcome | Result | p-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.
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.