N/A
N=762
Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
Meningococcal Infections · Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT00862277 ↗Enrolled (actual)
762
Serious AEs
—
Results posted
Jan 2011
Primary outcome: Primary: Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment — 53; 34; 20; 50 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Menactra® (Biological); Menomune® (Biological)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment |
53; 34; 20; 50; 29; 17 | — |
| PRIMARY Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment |
74.0; 19.1; 11.0; 24.9; 16.9; 8.58 | — |
Summary
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
Eligibility Criteria
Inclusion Criteria
- For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject
- For subjects aged 2 weeks
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses
- Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity
- History of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically)
- For Groups 1 and 2: Previous vaccination (including booster) against meningococcal disease, with the exception of the Menactra® or Menomune® vaccination received in trial MTA04, MTA12, MTA19, or MTA21
- Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)
Data sourced from ClinicalTrials.gov (NCT00862277). 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.