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| ID | Type | Description | Link |
|---|---|---|---|
| 20130090378 | Other Identifier | MFDS |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rMenB | Experimental | Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study. |
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| Placebo/MenACWY | Active Comparator | Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal B Recombinant vaccine rMenB+OMV NZ | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 and Day 61 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 06 Kosin University Gospel Hospital 34, amnam-dong | Seo-gu | Busan | 602-702 | South Korea | ||
| 05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26826544 | Derived | Lee HJ, Choe YJ, Hong YJ, Kim KH, Park SE, Kim YK, Oh CE, Lee H, Song H, Bock H, Casula D, Bhusal C, Arora AK. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trial. Vaccine. 2016 Feb 24;34(9):1180-6. doi: 10.1016/j.vaccine.2016.01.033. Epub 2016 Jan 28. |
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All enrolled subjects were included in the trial.
Subjects were recruited from 7 study sites in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | rMENB | Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study |
| FG001 | Placebo/MenACWY | Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Biological | 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. |
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| Meningococcal ACWY-CRM conjugate vaccine | Biological | 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. |
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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. |
| 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. | 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. | Day 1 and Day 61 |
| 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. | 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. | 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. | Day 1 through Day 61 |
| Ansan-si |
| Gyeonggi-do |
| 425-707 |
| South Korea |
| 04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup | Yangsan | Gyeongsangnam-do | 626-770 | South Korea |
| 07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil | Bundang-gu | Seongnam | 463-707 | South Korea |
| 01 Seoul National University Hospital 101 Daehang-ro, | Jongno-gu | Seoul | 110-744, | South Korea |
| 03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong | Yangch’ŏn-gu | Seoul | 158-710 | South Korea |
| 02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu | Incheon | 400-711 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | rMENB | Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study |
| BG001 | Placebo/MenACWY | Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was done on the Full Analysis Set (FAS) i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 1 and Day 61 |
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| Secondary | 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. | Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 1 and Day 61 |
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| Secondary | 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. | Analysis was done on the FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 61/ Day 1 |
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| Secondary | 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. | Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 61 |
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| Secondary | 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. | Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Day 1 and Day 61 |
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| Secondary | 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. | Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 61/Day 1 |
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| Secondary | 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. | Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data. | Posted | Number | Number of subjects | Day 1 through day 7 after each vaccination |
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| Secondary | 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. | Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data. | Posted | Number | number of subjects | Day 1 through Day 61 |
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Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rMENB | Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study | 2 | 174 | 167 | 175 | ||
| EG001 | Placebo/MenACWY | Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study | 0 | 88 | 63 | 88 | ||
| EG002 | Total | Total of subjects | 2 | 262 | 230 | 263 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTROENTERITIS | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| PAROVARIAN CYST | Reproductive system and breast disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| INJECTION SITE INDURATION | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| INJECTION SITE SWELLING | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| MALAISE | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| PYREXIA | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| EATING DISORDERS | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
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| Male |
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| 5/99 strain (Day 1) |
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| 5/99 strain (Day 61) |
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| NZ98/254 strain (Day 1) |
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| NZ98/254 strain (Day 61) |
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