Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001563-29 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4CMenB | Experimental |
| |
| MenACWY CRM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Men ACWY CRM | Biological | A single dose of a 0.5 mL injectable solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains. | One month after vaccinations |
| Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
| One month after vaccinations |
| Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains. | One month after vaccinations |
| Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
| One month after vaccinations |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda USL 7 of Siena | Siena | 53100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21177912 | Result | Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011 Mar;18(3):483-6. doi: 10.1128/CVI.00304-10. Epub 2010 Dec 22. | |
| 33020485 |
Not provided
Not provided
Approximately 250 adults were planned to be enrolled in this study but only a total of 54 subjects were enrolled after the screening for the inclusion and exclusion criteria.
Participants were enrolled at one site in Italy and one site in Germany.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 4CMenB | All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 4CMenB | All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains. | The analysis was done on the per protocol population. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month after vaccinations |
|
Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4CMenB (1st Vaccination) | All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Post dose 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA | Systematic Assessment | After first vaccination |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
Not provided
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 4CMenB |
| Biological |
All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm. |
|
| Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7. | One month after vaccinations |
| Derived |
| Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0. |
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain |
| OG002 | 4CMen B (NZ98/254) | All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain. |
|
|
| Primary | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
| The analysis was done on the per protocol population. | Posted | Number | 95% Confidence Interval | percentage | One month after vaccinations |
|
|
|
| Primary | Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains. | The analysis was done on the per protocol population. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month after vaccinations |
|
|
|
| Primary | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
| The analysis was done on the per protocol population. | Posted | Number | 95% Confidence Interval | percentage | One month after vaccinations |
|
|
|
| Primary | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7. | The analysis was done on the per protocol population. | Posted | Number | participants | One month after vaccinations |
|
|
|
| 0 |
| 53 |
| 52 |
| 53 |
| EG001 | 4CMenB (2nd Vaccination) | All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Post dose 2. | 0 | 52 | 51 | 52 |
| EG002 | 4CMenB (3rd Vaccination) | All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Post dose 3. | 0 | 50 | 50 | 50 |
| EG003 | Men ACWY-CRM | All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Post dose 1 MenACWY. | 0 | 41 | 19 | 41 |
|
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
Not provided
| D007239 | Infections |
|
| titer ≥4 (Post dose 2) |
|
| titer ≥4 (Before dose 3) N=24 |
|
| titer ≥4 (Post dose 3) N=39 |
|
| titer ≥8 (Baseline) |
|
| titer ≥8 (Post dose 1) N=25 |
|
| titer ≥8 (Post dose 2) |
|
| titer ≥8 (Before dose 3) N=24 |
|
| titer ≥8 (Post dose 3) N=39 |
|
| ≥4 fold increase (Post dose 1) N=25 |
|
| ≥4 fold increase (Post dose 2) |
|
| ≥4 fold increase (Before dose 3) N=24 |
|
| ≥4 fold increase (Post dose 3) N=39 |
|
| titers ≥8 |
|
| Injection pain (severe) |
|
| Erythema (any) |
|
| Erythema (severe) |
|
| Induration (any) |
|
| Induration (severe) |
|
| Nausea (any) |
|
| Nausea (severe) |
|
| Malaise (any) |
|
| Malaise (severe) |
|
| Myalgia (any) |
|
| Myalgia (severe) |
|
| Arthralgia (any) |
|
| Arthralgia (severe) |
|
| Headache (any) |
|
| Headache (severe) |
|
| Fever (≥ 38°C) |
|
| Stayed home |
|
| Analgesic, antipyretic medicine used |
|