A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

1,440

Participants

Timeline

Start Date

June 14, 2021

Primary Completion Date

February 2, 2024

Study Completion Date

February 2, 2024

Conditions
Infections, Meningococcal
Interventions
COMBINATION_PRODUCT

MenABCWY-2Gen low dose vaccine

MenABCWY-2Gen low dose vaccine is administered intramuscularly as 2 doses to participants in the ABCWY low dose Group in study Phase I, ABCWY low dose\_06 Group and ABCWY low dose\_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY low dose\_01 Group, ABCWY low doseS\_02 Group and ABCWY low doseS\_06 Group in study Phase II (Sourcing).

COMBINATION_PRODUCT

MenABCWY-2Gen high dose vaccine

MenABCWY-2Gen high dose vaccine is administered intramuscularly 2 doses to participants in the ABCWY high dose Group in study Phase I, ABCWY high dose\_06 Group and ABCWY high dose\_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY high dose\_01 Group, ABCWY high doseS\_02 Group and ABCWY high doseS\_06 Group in study Phase II (Sourcing).

COMBINATION_PRODUCT

Placebo

Placebo is administered intramuscularly as 2 doses to participants in the Placebo low dose Group, Placebo high dose Group in study Phase I and as 1 dose to participants in the ABCWY low dose\_06 Group, ABCWY low dose\_02 Group, ABCWY high dose\_06 Group, ABCWY high dose\_02 Group in study Phase II (Formulation and Schedule-finding).

COMBINATION_PRODUCT

MenB vaccine

MenB vaccine is administered intramuscularly as 2 doses in a 0,6-months schedule to participants in the Control Group in study Phase II (Formulation and Schedule-finding).

BIOLOGICAL

MenACWY vaccine

MenACWY vaccine is administered intramuscularly as 1 dose to participants in the Control Group in study Phase II (Formulation and Schedule-finding).

Trial Locations (53)

1000

GSK Investigational Site, Brussels

2010

GSK Investigational Site, Darlinghurst

2650

GSK Investigational Site, Edegem

4006

GSK Investigational Site, Fortitude Valley

4068

GSK Investigational Site, Taringa

4121

GSK Investigational Site, Tarragindi

6009

GSK Investigational Site, Nedlands

6163

GSK Investigational Site, Spearwood

6534

GSK Investigational Site, Linkebeek

9000

GSK Investigational Site, Ghent

20100

GSK Investigational Site, Turku

20520

GSK Investigational Site, Turku

29414

GSK Investigational Site, Charleston

33016

GSK Investigational Site, Miami Lakes

33175

GSK Investigational Site, Doral

34742

GSK Investigational Site, Istanbul

37212

GSK Investigational Site, Nashville

41103

GSK Investigational Site, Siemianowice Śląskie

41380

GSK Investigational Site, Kocaeli

45219

GSK Investigational Site, Cincinnati

50368

GSK Investigational Site, Wroclaw

65802

GSK Investigational Site, Springfield

68516

GSK Investigational Site, Lincoln

78229

GSK Investigational Site, San Antonio

80501

GSK Investigational Site, Longmont

80922

GSK Investigational Site, Colorado Springs

83642

GSK Investigational Site, Meridian

83686

GSK Investigational Site, Nampa

20241-180

GSK Investigational Site, Rio de Janeiro

40415-006

GSK Investigational Site, Salvador

15090-000

GSK Investigational Site, São José do Rio Preto

01227-200

GSK Investigational Site, São Paulo

04266-010

GSK Investigational Site, São Paulo

00180

GSK Investigational Site, Helsinki

85-048

GSK Investigational Site, Bydgoszcz

85-796

GSK Investigational Site, Bydgoszcz

82-300

GSK Investigational Site, Elblag

40-600

GSK Investigational Site, Katowice

40-648

GSK Investigational Site, Katowice

30-348

GSK Investigational Site, Krakow

30-644

GSK Investigational Site, Krakow

62-030

GSK Investigational Site, Luboń

33-100

GSK Investigational Site, Tarnów

87-100

GSK Investigational Site, Torun

55-100

GSK Investigational Site, Trzebnica

00-189

GSK Investigational Site, Warsaw

02-647

GSK Investigational Site, Warsaw

02-793

GSK Investigational Site, Warsaw

SE-506 30

GSK Investigational Site, Borås

SE-371 79

GSK Investigational Site, Karlskrona

SE-703 62

GSK Investigational Site, Örebro

SE-113 61

GSK Investigational Site, Stockholm

SE-901 85

GSK Investigational Site, Umeå

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY