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Also known as MenACWY liquid
MenACWY liquid vaccine with approximately 30% MenA FS · 2 trials · 2 indications
hSBA titers against N.meningitidis serogroup A were calculated in terms of GMTs adjusted for pre-vaccination titer.
hSBA titers against N. meningitidis serogroup A are 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). |
| 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 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 |
| 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 Respresentative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the proto...
It is an investigational meningococcal ACWY conjugate vaccine developed by GSK plc under the code GSK3536820A. It is a liquid formulation designed to protect against meningococcal infections and meningitis caused by serogroups A, C, W, and Y. It has completed Phase 2 clinical testing.
It is being developed for the prevention of meningococcal infections and meningitis caused by Neisseria meningitidis serogroups A, C, W, and Y. The Phase 2 program evaluated it in healthy adolescents and adults, including a study in participants 10 to 40 years of age.
GSK plc, which trades under the ticker GSK, is the developer of this vaccine. GSK Biologicals conducted the clinical studies of the candidate, referred to in trial documentation as GSK3536820A, and compared it with the company's licensed Menveo vaccine.
The vaccine is in Phase 2 development. Two Phase 2 trials have been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA for any indication.
Two completed Phase 2 trials studied the vaccine: NCT03652610 in healthy adults 18 to 40 years of age, and NCT03433482 in healthy adolescents and young adults 10 to 40 years of age. Both were randomized, double-blind, and active-controlled against Menveo.
Yes, GSK3536820A is the internal development code for this MenACWY liquid vaccine candidate. It is also referred to simply as the MenACWY liquid vaccine. The name reflects its liquid formulation containing approximately 30% MenA FS.