drugset / Trial / NCT02140762
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.
Timeline
- Start
- 2014-05
- Primary completion
- 2014-11
- Completion
- 2015-02
Publications
- Background Adu-Bobie J, Capecchi B, Serruto D, Rappuoli R, Pizza M. Two years into reverse vaccinology. Vaccine. 2003 Jan 30;21(7-8):605-10. doi: 10.1016/s0264-410x(02)00566-2.
- Background Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011 Jul;11(7):969-85. doi: 10.1517/14712598.2011.585965. Epub 2011 May 26.
- Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
- Welsch JA, Senders S, Essink B, Klein T, Smolenov I, Pedotti P, Barbi S, Verma B, Toneatto D. Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine. 2018 Aug 23;36(35):5309-5317. doi: 10.1016/j.vaccine.2018.07.016. Epub 2018 Jul 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MenABCWY | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Menveo | Vaccine | 0.5 ml | Intramuscular |