Phase 2
Completed N=127
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
Healthy
Source: ClinicalTrials.gov NCT00387725 ↗
Enrolled (actual)
127
Serious AEs
6.3%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 — 0.0; 33.3; 63.6; 83.3 percentage of participants
Summary
Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 |
0.0; 33.3; 63.6; 83.3; 0.0; 18.8 | — |
| PRIMARY Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 |
0.0; 68.8; 70.7; 90.7; 0.0; 87.5 | — |
| PRIMARY Percentage of Participants With at Least One Adverse Event (AE) |
90.5; 93.8; 93.3; 97.8 | — |
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria
- Aged 8 to 14 years at the time of enrollment.
- Healthy male or female subjects
- Negative urine pregnancy test for female subjects
Exclusion Criteria
Exclusion Criteria
- Prior vaccination with a meningococcal B vaccine
- Prior meningococcal disease
Data sourced from ClinicalTrials.gov (NCT00387725). 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. Informational only — not medical advice.