NCT01272180 - Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults | Biotech Hunter

Enrollment

484

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

October 31, 2011

Study Completion Date

September 30, 2012

Conditions

Invasive Meningococcal Disease

Interventions

BIOLOGICAL

Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.

Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.

BIOLOGICAL

Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.

Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.

BIOLOGICAL

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

BIOLOGICAL

Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.

Trial Locations (13)

35205

Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615, Birmingham

37087

Focus Research Group,201 Signature Place, Lebanon

40004

Kentucky Pediatric/Adult Research, 201 south 5th street, Bardstown

40291

Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2, Louisville

45420

Ohio Pediatric Research Association, 1775 Delco Park Drive, Kettering

45424

Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C, Huber Heights

90723

Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301, Paramount

93637

Madera Family Medical Group,1111 West 4th Street, Madera

05-080

"Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperuss.c, ul.Kościuszki 41", Izabelin (Warszawa)

31-223

NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12, Krakow

31-422

NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15, Krakow

01-809

Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80, Warsaw

50-354

Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44, Wroclaw