The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
264
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.
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.
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.
06 Kosin University Gospel Hospital 34, amnam-dong
Seo-gu, Busan, South Korea
05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu
Ansan-si, Gyeonggi-do, South Korea
04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup
Yangsan, Gyeongsangnam-do, South Korea
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
Time frame: Day 1 and Day 61
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.
Time frame: Day 1 and Day 61
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.
Time frame: Day 61/ Day 1
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.
Time frame: Day 61
The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.
The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.
Time frame: Day 1 and Day 61
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07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil
Bundang-gu, Seongnam, South Korea
01 Seoul National University Hospital 101 Daehang-ro,
Jongno-gu, Seoul, South Korea
03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong
Yangch’ŏn-gu, Seoul, South Korea
02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu
Incheon, South Korea
The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.
The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.
Time frame: Day 61/Day 1
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Time frame: Day 1 through day 7 after each vaccination
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Time frame: Day 1 through Day 61