drugset / Trial / NCT01214850
Novartis Vaccine and Diagnostics Carriage Trial
RandomizedParallel-groupSingle-blindPrevention
Summary
The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population.
Timeline
- Start
- 2010-09
- Primary completion
- 2012-01
- Completion
- 2012-01
Outcome
Missed primary endpoint
registry analysis (superiority or other test); rMenB+OMV vs Control; p = 0.3828; Odds Ratio (OR) 1.185 (95% CI 0.809 to 1.737); Regression, Logistic NCT01214850 ↗
registry MenACWY vs Control; Odds Ratio (OR) 0.840 (95% CI 0.555 to 1.273); Regression, Logistic NCT01214850 ↗
paper Although we detected no significant difference between groups at 1 month after vaccine course PMID 25145775 ↗
Publications
- Lemee L, Hong E, Etienne M, Deghmane AE, Delbos V, Terrade A, Berthelot G, Caron F, Taha MK. Genetic diversity and levels of expression of factor H binding protein among carriage isolates of Neisseria meningitidis. PLoS One. 2014 Sep 23;9(9):e107240. doi: 10.1371/journal.pone.0107240. eCollection 2014.
- Read RC, Baxter D, Chadwick DR, Faust SN, Finn A, Gordon SB, Heath PT, Lewis DJ, Pollard AJ, Turner DP, Bazaz R, Ganguli A, Havelock T, Neal KR, Okike IO, Morales-Aza B, Patel K, Snape MD, Williams J, Gilchrist S, Gray SJ, Maiden MC, Toneatto D, Wang H, McCarthy M, Dull PM, Borrow R. Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. Lancet. 2014 Dec 13;384(9960):2123-31. doi: 10.1016/S0140-6736(14)60842-4. Epub 2014 Aug 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MenACWY-CRM | Vaccine | — | — |
| Subject | rMenB+OMV NZ | Unknown | — | — |
| Comparator | IC51 | Vaccine | — | — |