Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)

PHASE3CompletedINTERVENTIONAL
Enrollment

570

Participants

Timeline

Start Date

September 3, 2019

Primary Completion Date

September 14, 2020

Study Completion Date

September 14, 2020

Conditions
Meningococcal Immunisation (Healthy Volunteers)
Interventions
BIOLOGICAL

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine

Pharmaceutical form: Solution for injection Route of administration: IM

BIOLOGICAL

Meningococcal Group B vaccine (Trumenba®)

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

BIOLOGICAL

Meningococcal group B vaccine (Bexsero®)

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

Trial Locations (30)

16505

Investigational Site Number 8400038, Erie

22903

Investigational Site Number 8400037, Charlottesville

29414

Investigational Site Number 8400039, Charleston

35205

Investigational Site Number 8400012, Birmingham

37388

Investigational Site Number 8400029, Tullahoma

37660

Investigational Site Number 8400018, Kingsport

40004

Investigational Site Number 8400013, Bardstown

40517

Investigational Site Number 8400033, Lexington

44121

Investigational Site Number 8400028, South Euclid

45414

Investigational Site Number 8400030, Dayton

63044

Investigational Site Number 8400034, Bridgeton

68504

Investigational Site Number 8400027, Lincoln

68505

Investigational Site Number 8400002, Lincoln

68516

Investigational Site Number 8400004, Lincoln

73069

Investigational Site Number 8400009, Norman

84037

Investigational Site Number 8400031, Kaysville

84041

Investigational Site Number 8400001, Layton

Investigational Site Number 8400014, Layton

84057

Investigational Site Number 8400040, Orem

84064

Investigational Site Number 8400011, Provo

84067

Investigational Site Number 8400023, Roy

84095

Investigational Site Number 8400015, South Jordan

Investigational Site Number 8400036, South Jordan

84107

Investigational Site Number 8400003, Salt Lake City

84109

Investigational Site Number 8400007, Salt Lake City

Investigational Site Number 8400022, Salt Lake City

92123-1881

Investigational Site Number 8400005, San Diego

84075-9645

Investigational Site Number 8400032, Syracuse

84088-8865

Investigational Site Number 8400024, West Jordan

00981

Investigational Site Number 6300001, San Juan

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT04084769 - Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4) | Biotech Hunter | Biotech Hunter