Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

1,250

Participants

Timeline

Start Date

January 25, 2021

Primary Completion Date

May 3, 2023

Study Completion Date

September 29, 2023

Conditions
Meningitis, Meningococcal
Interventions
COMBINATION_PRODUCT

MenABCWY vaccine

2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.

COMBINATION_PRODUCT

Placebo

1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group

BIOLOGICAL

MenACWY vaccine

1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group

COMBINATION_PRODUCT

MenB vaccine

2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.

Trial Locations (69)

1426

GSK Investigational Site, Buenos Aires

2010

GSK Investigational Site, Darlinghurst

2035

GSK Investigational Site, Maroubra

2259

GSK Investigational Site, Kanwal

2450

GSK Investigational Site, Coffs Harbour

3052

GSK Investigational Site, Parkville

3168

GSK Investigational Site, Clayton

4068

GSK Investigational Site, Taringa

4121

GSK Investigational Site, Tarragindi

5000

GSK Investigational Site, Córdoba

5800

GSK Investigational Site, Río Cuarto

6009

GSK Investigational Site, Nedlands

13210

GSK Investigational Site, Syracuse

15025

GSK Investigational Site, Pittsburgh

15063

GSK Investigational Site, Monongahela

15213

GSK Investigational Site, Pittsburgh

15217

GSK Investigational Site, Pittsburgh

16066

GSK Investigational Site, Cranberry Township

20017

GSK Investigational Site, Washington D.C.

27612

GSK Investigational Site, Raleigh

28304

GSK Investigational Site, Fayetteville

28401

GSK Investigational Site, Wilmington

29406

GSK Investigational Site, Charleston

29607

GSK Investigational Site, Greenville

30328

GSK Investigational Site, Sandy Springs

30338

GSK Investigational Site, Atlanta

31904

GSK Investigational Site, Columbus

32127

GSK Investigational Site, Port Orange

33126

GSK Investigational Site, Miami

33135

GSK Investigational Site, Miami

39531

GSK Investigational Site, Biloxi

40291

GSK Investigational Site, Louisville

48236

GSK Investigational Site, Grosse Pointe Woods

61822

GSK Investigational Site, Champaign

62301

GSK Investigational Site, Quincy

72401

GSK Investigational Site, Jonesboro

75010

GSK Investigational Site, Carrollton

75024

GSK Investigational Site, Plano

75251

GSK Investigational Site, Dallas

75605

GSK Investigational Site, Longview

77055

GSK Investigational Site, Houston

77450

GSK Investigational Site, Katy

77706

GSK Investigational Site, Beaumont

78745

GSK Investigational Site, Austin

83642

GSK Investigational Site, Meridian

84037

GSK Investigational Site, Kaysville

84041

GSK Investigational Site, Layton

84067

GSK Investigational Site, Roy

84075

GSK Investigational Site, Syracuse

87102

GSK Investigational Site, Albuquerque

91790

GSK Investigational Site, West Covina

91911

GSK Investigational Site, Chula Vista

92220

GSK Investigational Site, Banning

98105

GSK Investigational Site, Seattle

02114

GSK Investigational Site, Boston

02725

GSK Investigational Site, Fall River

01844

GSK Investigational Site, Methuen

02135

GSK Investigational Site, Roslindale

02886-6110

GSK Investigational Site, Warwick

77381-3527

GSK Investigational Site, The Woodlands

C1222

GSK Investigational Site, CABA

C1425AWK

GSK Investigational Site, Ciudad Autonoma Buenos Aires

B7600FYH

GSK Investigational Site, Mar del Plata

T4000IHE

GSK Investigational Site, San Miguel de Tucumán

T4000NWB

GSK Investigational Site, San Miguel de Tucumán

C1428

GSK Investigational Site, Buenos Aires

N1H 1B1

GSK Investigational Site, Guelph

N7T 4X3

GSK Investigational Site, Sarnia

M9V 4B4

GSK Investigational Site, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04707391 - Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine | Biotech Hunter | Biotech Hunter