A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
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.
Timeline
- Start
- 2009-02
- Primary completion
- 2014-03
- Completion
- 2014-03
Outcome
Met primary endpoint
registry NUMBER rLP2086 60 mcg- Stage 1: Subfamily A Strain A05 (N= 80, 18, 115, 106): 88.9 Percentage of participants NCT00808028 ↗
registry analysis (superiority or other test); rLP2086 60 mcg- Stage 1; p = 0.0007; Binomial Distribution NCT00808028 ↗
registry NUMBER rLP2086 60 mcg- Stage 1: Subfamily B Strain B02 (N= 84, 21, 121, 114): 71.4 Percentage of participants NCT00808028 ↗
registry analysis (superiority or other test); rLP2086 60 mcg- Stage 1; p = 0.0392; Binomial Distribution NCT00808028 ↗
registry NUMBER rLP2086 60 mcg- Stage 1: Subfamily A Strain A05 (N= 73, 19, 111,100): 89.5 Percentage of participants NCT00808028 ↗
registry analysis (superiority or other test); rLP2086 60 mcg- Stage 1; p = 0.0004; Binomial Distribution NCT00808028 ↗
registry NUMBER rLP2086 60 mcg- Stage 1: Subfamily B Strain B02 (N= 79, 21, 112,105): 81.0 Percentage of participants NCT00808028 ↗
registry analysis (superiority or other test); rLP2086 60 mcg- Stage 1; p = 0.0036; Binomial Distribution NCT00808028 ↗
Publications
- Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
- Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.
- Marshall HS, Richmond PC, Beeslaar J, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Lee SS, Perez JL; 6108A12001 Study Investigators. Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2017 Jan;17(1):58-67. doi: 10.1016/S1473-3099(16)30314-0. Epub 2016 Oct 11.
- Richmond PC, Marshall HS, Nissen MD, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Beeslaar J, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Perez JL; 2001 Study Investigators. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012 Aug;12(8):597-607. doi: 10.1016/S1473-3099(12)70087-7. Epub 2012 May 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rLP2086 | Vaccine | 60 ug | — |
| Subject | rLP2086 | Vaccine | 120 ug | — |
| Subject | rLP2086 | Vaccine | 200 ug | — |