Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

November 18, 2021

Primary Completion Date

February 5, 2027

Study Completion Date

February 5, 2027

Conditions
Meningitis, Meningococcal
Interventions
COMBINATION_PRODUCT

MenABCWY vaccine

Two doses of the MenABCWY vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, on a 0-, 24-month schedule in the ABCWY-24 Group, and a 0-, 48-month schedule in the ABCWY-48 Group.

COMBINATION_PRODUCT

Placebo

Single dose of Placebo (saline solution in pre-filled syringe), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1441 in the ABCWY-24 Group, and at Day 721 in the ABCWY-48 Group.

Trial Locations (30)

13850

GSK Investigational Site, Endwell

13905

GSK Investigational Site, Binghamton

16269

GSK Investigational Site, Leipzig

20016

GSK Investigational Site, Washington D.C.

28226

GSK Investigational Site, Charlotte

29414

GSK Investigational Site, Charleston

31210

GSK Investigational Site, Macon

33156

GSK Investigational Site, Miami

33173

GSK Investigational Site, Miami

35205

GSK Investigational Site, Birmingham

37660

GSK Investigational Site, Kingsport

40503

GSK Investigational Site, Nicholasville

49565

GSK Investigational Site, Bramsche

59804

GSK Investigational Site, Missoula

68134

GSK Investigational Site, Omaha

68309

GSK Investigational Site, Mannheim

68510

GSK Investigational Site, Lincoln

68803

GSK Investigational Site, Grand Island

71037

GSK Investigational Site, Haughton

75024

GSK Investigational Site, Austin

76863

GSK Investigational Site, Herxheim

76889

GSK Investigational Site, Schweigen-Rechtenbach

80216

GSK Investigational Site, Missoula

83471

GSK Investigational Site, Schönau am Königssee

84037

GSK Investigational Site, Layton

84088

GSK Investigational Site, Valparaiso

85745

GSK Investigational Site, Tucson

93003

GSK Investigational Site, Ventura

97030

GSK Investigational Site, Gresham

77555 1115

GSK Investigational Site, Galveston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT05087056 - Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents | Biotech Hunter | Biotech Hunter