Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MenACWY liquid · 1 trial · 1 indication
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...
MenACWY liquid is an investigational meningococcal ACWY conjugate vaccine being studied for the prevention of meningitis and meningococcal disease. It is intended for use in healthy adolescents and young adults aged 10 to 40 years. The vaccine is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
MenACWY liquid is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and is currently in Phase 2 clinical development for the prevention of meningococcal disease.
MenACWY liquid is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine is being evaluated for safety and immunogenicity in healthy adolescents and young adults.
MenACWY liquid has one completed Phase 2 clinical trial, identified as NCT03433482. The study investigated the safety and immunogenicity of different formulations of GSK's meningococcal ACWY conjugate vaccine, including MenACWY liquid and Menveo, in 1,707 healthy adolescents and young adults aged 10 to 40 years.
MenACWY liquid is a meningococcal ACWY conjugate vaccine being developed by GSK, and it was studied alongside Menveo in a Phase 2 clinical trial. The trial compared different formulations of GSK's meningococcal ACWY conjugate vaccine, including MenACWY liquid and Menveo, to assess their safety and immunogenicity.
MenACWY liquid is a conjugate vaccine designed to elicit an immune response against Neisseria meningitidis serogroups A, C, W, and Y. By presenting these bacterial antigens to the immune system, the vaccine aims to generate protective antibodies that prevent meningococcal disease. The exact mechanism is being evaluated in clinical trials.