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Licensed GSK MenACWY vaccine

Phase 2

Infections, Meningococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Feb 9, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment996

FDA Designations

No designations recorded

Clinical trial landscape

Licensed GSK MenACWY vaccine · 1 trial · 1 indication

Phase 2 1
NCT03652610A 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 AgeInfections, Meningococcal
COMPLETED996 Analytics
PHASE2COMPLETED
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
Infections, MeningococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group, and Between-group Ratios
At Day 29

hSBA titers against N.meningitidis serogroup A were calculated in terms of GMTs adjusted for pre-vaccination titer.

Secondary Endpoints

hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios
At Day 1 and Day 29
Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y
At Day 29
Percentages of Subjects With a ≥4 Fold Rise in hSBA Antibody Titers for Each of the N.Meningitidis Serogroups A, C,W and Y for Each Vaccine Group, and Between-group Differences
At Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
GSK3536820A ACWY_Liq GroupEXPERIMENTALHealthy 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 GroupACTIVE_COMPARATORHealthy adults 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).

Interventions

NameTypeDescription
MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A)BIOLOGICALSingle dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm
Licensed GSK MenACWY vaccine (Menveo)BIOLOGICALSingle dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites30

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...

Countries:AustraliaBelgiumCanadaGermanyItaly
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Frequently asked questions about Licensed GSK MenACWY vaccine

What is the licensed GSK MenACWY vaccine used for?

The licensed GSK MenACWY vaccine is used for meningococcal infections, specifically to prevent disease caused by Neisseria meningitidis serogroups A, C, W, and Y. It is being studied in healthy adults aged 18 to 40 years to evaluate its safety and immunogenicity.

Who makes the licensed GSK MenACWY vaccine?

The licensed GSK MenACWY vaccine is developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this meningococcal vaccine to assess its safety and immune response in adult populations.

What phase is the licensed GSK MenACWY vaccine in?

The licensed GSK MenACWY vaccine is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved for general use, and it is currently being evaluated in a completed Phase 2 trial involving healthy adults.

What clinical trials is the licensed GSK MenACWY vaccine in?

The licensed GSK MenACWY vaccine was studied in clinical trial NCT03652610, a Phase 2 study investigating the safety and immunogenicity of different formulations of GSK's meningococcal ACWY conjugate vaccine compared to Menveo. The trial enrolled 996 healthy adults aged 18 to 40 years across Australia, Belgium, Canada, Germany, and Italy.

Is the licensed GSK MenACWY vaccine the same as Menveo?

The licensed GSK MenACWY vaccine is not the same as Menveo. In clinical trial NCT03652610, the GSK vaccine formulations (GSK3536820A and Menveo) were compared, with Menveo serving as an active control. The study assessed the safety and immunogenicity of the different formulations.

How does the licensed GSK MenACWY vaccine work?

The licensed GSK MenACWY vaccine is a conjugate vaccine designed to elicit an immune response against meningococcal serogroups A, C, W, and Y. It works by presenting bacterial polysaccharides linked to a carrier protein to stimulate the immune system to produce protective antibodies.