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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03433482 | A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age | PHASE2 | COMPLETED | 1,707 | — | — | Aug 30, 2018 | Dec 17, 2019 | Feb 17, 2021 | 49 | Brazil, Estonia +7 |
hSBA titers against N. meningitidis serogroup A are calculated in terms of GMTs adjusted for pre-vaccination titer.
| Arm | Type | Description |
|---|---|---|
| GSK3536820A ACWY_Liq24 Group | EXPERIMENTAL | Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1. |
| ACWY_1 Group | ACTIVE_COMPARATOR | Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. |
| GSK3536820A ACWY_Liq30 Group | EXPERIMENTAL | Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2. |
| ACWY_2 Group | ACTIVE_COMPARATOR | Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2. |
| Name | Type | Description |
|---|---|---|
| MenACWY liquid | BIOLOGICAL | At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY\_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY\_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm. |
| MenACWY | BIOLOGICAL | At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY\_1) or in phase 2 of the study (subjects randomized to study arm ACWY\_2), administered 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 Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protoc...