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A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Children, Adolescents and Adults in Russia
To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.
Details
| Lead sponsor | Novartis Vaccines |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 198 |
| Start date | 2012-11 |
| Completion | 2013-03 |
Conditions
- Meningococcal Disease
Interventions
- MenACWY-CRM
Primary outcomes
- Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination — Day 29
Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4
Countries
Russia