NCT01992536 - Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180) | Biotech Hunter

Enrollment

194

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

May 31, 2014

Study Completion Date

April 30, 2015

Conditions

Meningococcal Disease

Interventions

BIOLOGICAL

MenABCWY+OMV

"Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a full dose) plus the fully lyophilized MenACWY vaccine"

BIOLOGICAL

MenABCWY+¼OMV

Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine

BIOLOGICAL

Placebo

Saline solution for injection (0.5mL)

Trial Locations (13)

35205

Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615, Birmingham

37087

Site 22, Focus Research Group 201 Signature Place, Lebanon

40004

Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street, Bardstown

40291

Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2, Louisville

45414

Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200, Dayton

45420

Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive, Kettering

90723

Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301, Paramount

93637

Site 24, Madera Family Medical Group 1111 West 4th Street, Madera

05-080

"Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus s.c.", ul.Kościuszki 41

31-223

Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska, Ul. Braci Kiemliczów 14

31-422

Site 12, NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15

01-809

Site 14, Klinika Pediatrii Centrum Medycznego Kształcenia Podyplomowego,Szpital Bielański, Ul. Cegłowska 80

50-354

Site 11, Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44