Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

PHASE3CompletedINTERVENTIONAL
Enrollment

264

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Meningococcal Disease
Interventions
BIOLOGICAL

Meningococcal B Recombinant vaccine rMenB+OMV NZ

Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.

BIOLOGICAL

Placebo

Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.

BIOLOGICAL

Meningococcal ACWY-CRM conjugate vaccine

Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.

Trial Locations (7)

602-702

06 Kosin University Gospel Hospital 34, amnam-dong, Seo-gu

425-707

05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu, Ansan-si

626-770

04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup, Yangsan

463-707

07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil, Bundang-gu

110-744,

01 Seoul National University Hospital 101 Daehang-ro,, Jongno-gu

158-710

03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong, Yangch’ŏn-gu

400-711

02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu, Incheon

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Novartis Vaccines

INDUSTRY