Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00474487 | A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults | PHASE3 | COMPLETED | 2,831 | — | — | May 1, 2007 | Feb 1, 2008 | Apr 21, 2014 | 2 | Argentina, Colombia |
Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Novartis MenACWY Vaccine (19 to 55 Years) | EXPERIMENTAL | Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years |
| Licensed polysaccharide vaccine | ACTIVE_COMPARATOR | Licensed meningococcal ACWY polysaccharide vaccine |
| Licensed Conjugate Vaccine | ACTIVE_COMPARATOR | Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine |
| Novartis MenACWY Vaccine (56 to 65 Years) | EXPERIMENTAL | Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years |
| Name | Type | Description |
|---|---|---|
| Meningococcal ACWY Polysaccharide Vaccine | BIOLOGICAL | One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection. |
| MenACWY CRM (19 to 55 years) | BIOLOGICAL | One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age. |
| Meningococcal ACWY Conjugate Vaccine | BIOLOGICAL | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection. |
| Novartis MenACWY Vaccine (56 to 65 Years) | BIOLOGICAL | One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age. |
Inclusion Criteria: * individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent * individuals who are available for all visits and telephone calls scheduled for the study; * individuals who are in good health E...