drugset / Trial / NCT03135834
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.
Timeline
- Start
- 2017-04-24
- Primary completion
- 2022-10-25
- Completion
- 2022-10-25
Publications
- Peterson J, Drazan D, Moughan B, Maguire JD, Zolotas L, Maansson R, O'Neill R, Peyrani P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose. Vaccine. 2025 Jan 1;43(Pt 1):126469. doi: 10.1016/j.vaccine.2024.126469. Epub 2024 Nov 8.
- Peterson J, Drazan D, Czajka H, Maguire J, Pregaldien JL, Seppa I, Maansson R, O'Neill R, Balmer P, Jodar L, Jansen KU, Anderson AS, Perez JL, Beeslaar J. Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults: an observer-blind, active-controlled, randomised trial. Lancet Infect Dis. 2023 Dec;23(12):1370-1382. doi: 10.1016/S1473-3099(23)00191-3. Epub 2023 Aug 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MenABCWY | Vaccine | 0.5 ml | Intramuscular |
| Subject | Menveo | Vaccine | — | — |
| Subject | rLP2086 | Vaccine | — | — |