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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005815-25 | EudraCT Number |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rMenB+OMV NZ | Experimental | A single 0.5mL dose of the study vaccine will be administered intramuscularly in the deltoid muscle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rMenB+OMV NZ | Biological | Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination. | Day1 and Day 91 |
| Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline. | Day1 and Day 91 |
| Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. | Day1 and Day91 |
| Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. | Day1 and Day91 |
| Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule. |
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Inclusion Criteria:
Sponsor's employees are considered eligible to participate in the trial as per inclusion criteria.
Exclusion Criteria:
Pregnancy or nursing (breastfeeding) mothers;
Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry;
Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria;
History of any serogroup B meningococcal vaccine administration;
Previous known or suspected disease caused by N. meningitidis;
History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine;
Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study;
History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
Any significant chronic infection;
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
Family members and household members of research staff;
Participation in another clinical trial within the last 30 days or planned for during study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis site | Marburg | 35037 | Germany |
All enrolled subjects were included in the trial.
Subjects were recruited from single study center in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | rMenB+OMV NZ | Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. |
| Day 91 |
| Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule | The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination. | Day 1 and Day 91 |
| Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline. | Day 1 and Day 91 |
| Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline. | Day 1 and Day 91 |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported. | Day 1 through Day 7 postvaccination. |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91. | Day 1 through Day 91 postvaccination. |
| Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported. | Day 1 through Day 91 postvaccination. |
| COMPLETED |
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| NOT COMPLETED |
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Subjects received two doses of rMenB+OMV NZ at 0 month and 2 month schedule.
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| ID | Title | Description |
|---|---|---|
| BG000 | rMenB+OMV NZ | Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule. |
| Units | Counts |
|---|---|
| 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 | year |
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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 | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination. | Analysis was done on Full Analysis Set | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day1 and Day 91 |
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| Primary | Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline. | The analysis was done on the Full Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day1 and Day 91 |
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| Primary | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. | Analysis was done on Full Analysis Set. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day1 and Day91 |
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| Primary | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. | Analysis was done on Full Analysis Set. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Day1 and Day91 |
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| Primary | Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule. | The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. | Analysis was done on Full Analysis Set. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 91 |
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| Primary | Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule | The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination. | Analysis was done on Full Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | U/mL | Day 1 and Day 91 |
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| Primary | Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline. | Analysis was done on Full Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 and Day 91 |
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| Primary | Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline. | Analysis was done on Full Analysis Set. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Day 1 and Day 91 |
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| Primary | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported. | Analysis was done on Solicited Safety Set. | Posted | Number | Number of Subjects | Day 1 through Day 7 postvaccination. |
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| Primary | Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91. | Analysis was done on Unsolicited Safety Set. | Posted | Number | Number of subjects | Day 1 through Day 91 postvaccination. |
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| Primary | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported. | Analysis was done on Unsolicited Safety Set. | Posted | Number | Number of subjects | Day 1 through Day 91 postvaccination. |
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Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
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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+OMVNZ | Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule. | 0 | 13 | 13 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| CHILLS | General disorders | MedDRA (10.0) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (10.0) | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA (10.0) | Systematic Assessment |
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| INJECTION SITE INDURATION | General disorders | MedDRA (10.0) | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA (10.0) | Systematic Assessment |
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| INJECTION SITE SWELLING | General disorders | MedDRA (10.0) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (10.0) | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryCpontactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| After 2nd vaccination (Day 91)(N=12) |
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| NZ98/254 Prevaccination (Day 1) |
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| Post 2nd vaccination (Day 91)(N=12) |
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| M10713 Prevaccination (Day 1) |
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| Post second vaccination (Day 91)(N=12) |
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