Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

945

Participants

Timeline

Start Date

August 25, 2020

Primary Completion Date

November 21, 2023

Study Completion Date

November 21, 2023

Conditions
Infections, Meningococcal
Interventions
COMBINATION_PRODUCT

Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)

1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group.

BIOLOGICAL

Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)

1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group.

COMBINATION_PRODUCT

Placebo

1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group.

Trial Locations (53)

13045

GSK Investigational Site, Cortland

15025

GSK Investigational Site, Pittsburgh

15213

GSK Investigational Site, Pittsburgh

15217

GSK Investigational Site, Pittsburgh

15234

GSK Investigational Site, Pittsburgh

16043

GSK Investigational Site, Chiavari GE

16148

GSK Investigational Site, Hermitage

16508

GSK Investigational Site, Erie

20122

GSK Investigational Site, Milan

20162

GSK Investigational Site, Milan

22044

GSK Investigational Site, Falls Church

23294

GSK Investigational Site, Richmond

27103

GSK Investigational Site, Winston-Salem

28226

GSK Investigational Site, Charlotte

29414

GSK Investigational Site, Charleston

33470

GSK Investigational Site, Wellington

40004

GSK Investigational Site, Bardstown

40291

GSK Investigational Site, Louisville

47715

GSK Investigational Site, Evansville

57108

GSK Investigational Site, Sioux Falls

68504

GSK Investigational Site, Lincoln

68505

GSK Investigational Site, Lincoln

68516

GSK Investigational Site, Lincoln

68526

GSK Investigational Site, Lincoln

70508

GSK Investigational Site, Lafayette

71122

GSK Investigational Site, Foggia

75010

GSK Investigational Site, Austin

75024

GSK Investigational Site, Plano

75093

GSK Investigational Site, Plano

75165

GSK Investigational Site, Waxahachie

75251

GSK Investigational Site, Dallas

77584

GSK Investigational Site, Houston

77901

GSK Investigational Site, Victoria

78613

GSK Investigational Site, Austin

78726

GSK Investigational Site, Austin

83686

GSK Investigational Site, Nampa

83687

GSK Investigational Site, Nampa

83702

GSK Investigational Site, Boise

84057

GSK Investigational Site, Orem

84075

GSK Investigational Site, Syracuse

84095

GSK Investigational Site, South Jordan

84107

GSK Investigational Site, Salt Lake City

85238

GSK Investigational Site, Phoenix

90027

GSK Investigational Site, Los Angeles

90201

GSK Investigational Site, Bell Gardens

94596

GSK Investigational Site, Walnut Creek

94611

GSK Investigational Site, Oakland

95051

GSK Investigational Site, Santa Clara

95119

GSK Investigational Site, San Jose

95661

GSK Investigational Site, Roseville

95815

GSK Investigational Site, Sacramento

97330

GSK Investigational Site, Corvallis

75230-2571

GSK Investigational Site, Dallas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04318548 - Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age | Biotech Hunter | Biotech Hunter