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MenACWY-CRM · 1 trial · 2 indications
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
| Arm | Type | Description |
|---|---|---|
| 2 through 5 years (1 Vac) MenACWY-CRM 1 | PLACEBO_COMPARATOR | Subjects 2 through 5 years received one vaccination of MenACWY-CRM |
| 2 through 5 years (2 Vac) MenACWY-CRM 2 | ACTIVE_COMPARATOR | Subjects 2 through 5 years received two vaccinations of MenACWY-CRM |
| 6 through 10 years (1 Vac) MenACWY-CRM 3 | PLACEBO_COMPARATOR | Subjects 6 through 10 years received one vaccination of MenACWY-CRM |
| 6 through 10 years (2 Vac) MenACWY-CRM 4 | ACTIVE_COMPARATOR | Subjects 6 through 10 years received two vaccinations of MenACWY-CRM |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM | BIOLOGICAL | The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm |
Inclusion Criteria: * Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations Exclusion Criteria: 1. Unwilling or unable to give written informed assent or consent to participate in the study. 2. Perceived to be unreliable o...
MenACWY-CRM is an investigational vaccine being studied for the prevention of meningococcal disease, a serious bacterial infection. It is designed for use in healthy children aged 2 through 10 years. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
MenACWY-CRM is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in pediatric populations.
MenACWY-CRM is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory agencies. A Phase 3 trial has been completed to assess its immunogenicity, safety, and antibody persistence in healthy children.
MenACWY-CRM has one completed Phase 3 clinical trial, registered as NCT01682876. This study evaluated the immunogenicity, safety, and one-year persistence of antibodies after one or two doses of the vaccine in healthy children aged 2 through 10 years in the United States.
MenACWY-CRM is classified as a monoclonal antibody modality, though it functions as a conjugate vaccine. It is designed to elicit an immune response against meningococcal serogroups A, C, W, and Y. The vaccine is being studied for its ability to generate protective antibodies in children.