Phase 2
N=539
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Meningitis, Meningococcal
Bottom Line
View on ClinicalTrials.gov: NCT00808028 ↗Enrolled (actual)
539
Serious AEs
2.0%
Results posted
Apr 2015
Primary outcome: Primary: Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 — 1.3; 88.9; 83.5; 87.7 Percentage of participants — p=>0.9999
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- meningococcal B rLP2086 vaccine. (Biological); normal saline (placebo) (Other)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 |
1.3; 88.9; 83.5; 87.7; 0.0; 71.4 | >0.9999 |
| PRIMARY Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 |
5.5; 89.5; 92.8; 94.0; 1.3; 81.0 | >0.9999 |
| PRIMARY Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 |
44.6; 81.8; 38.9; 47.2; 4.1; 18.2 | — |
| PRIMARY Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 |
2.5; 4.1; 2.0 | — |
| SECONDARY Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level |
10.9; 0.0; 10.0; 12.0; 3.1; 0.0 | — |
Summary
The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
- Negative urine pregnancy test for all female subjects.
- Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion Criteria
- History of any invasive meningococcal disease.
- A previous anaphylactic or severe vaccine-associated adverse reaction.
- Any clinically significant chronic disease.
- A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
- Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
Data sourced from ClinicalTrials.gov (NCT00808028). 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.