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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03652610 | A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age | PHASE2 | COMPLETED | 996 | — | — | Sep 7, 2018 | Jun 11, 2019 | Feb 9, 2021 | 30 | Australia, Belgium +3 |
hSBA titers against N.meningitidis serogroup A were calculated in terms of GMTs adjusted for pre-vaccination titer.
| Arm | Type | Description |
|---|---|---|
| GSK3536820A ACWY_Liq Group | EXPERIMENTAL | Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS. |
| ACWY Group | ACTIVE_COMPARATOR | Healthy adults 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo). |
| Name | Type | Description |
|---|---|---|
| MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A) | BIOLOGICAL | Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm |
| Licensed GSK MenACWY vaccine (Menveo) | BIOLOGICAL | Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm |
Inclusion Criteria: 1. Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/Legally Acceptable Respresentative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the proto...