Meningococcal Disease
Conditions
Keywords
Meningococcal disease, prevention, vaccination
Brief summary
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.
Interventions
BIOLOGICALMen ACWY CRM
A single dose of a 0.5 mL injectable solution
BIOLOGICAL4CMenB
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.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults,18 through 50 years of age, who were or might be routinely exposed to N. meningitidis cultures
Exclusion criteria
* Previous ascertained or suspected disease caused by N. meningitidis; * Pregnancy or breastfeeding; * History of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; * Any present or suspected serious acute or chronic disease * Known or suspected autoimmune disease or impairment /alteration of immune function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | One month after vaccinations | Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains. |
| Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | One month after vaccinations | 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: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination |
| Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | One month after vaccinations | Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains. |
| Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | One month after vaccinations | 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: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination |
| Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | One month after vaccinations | 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. |
Countries
Italy
Participant flow
Recruitment details
Participants were enrolled at one site in Italy and one site in Germany.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Events or Death | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | 4CMenB |
|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 6.1 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 52 / 53 | 51 / 52 | 50 / 50 | 19 / 41 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 | 0 / 50 | 0 / 41 |
Outcome results
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.
Time frame: One month after vaccinations
Population: The analysis was done on the per protocol population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4CMenB (44/76-SL) | Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | 54 titer |
| 4CMenB (5/99) | Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | 42 titer |
| 4CMen B (NZ98/254) | Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | 90 titer |
| MenACWY-CRM (Y) | Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | 36 titer |
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.
Time frame: One month after vaccinations
Population: The analysis was done on the per protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4CMenB (44/76-SL) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Before dose 3 titer(N=24) | 26 titer |
| 4CMenB (44/76-SL) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 1 titer (N=25) | 33 titer |
| 4CMenB (44/76-SL) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 3 titer (N=39) | 95 titer |
| 4CMenB (44/76-SL) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Baseline titer | 2.5 titer |
| 4CMenB (44/76-SL) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 2 titer | 93 titer |
| 4CMenB (5/99) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 3 titer (N=39) | 269 titer |
| 4CMenB (5/99) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Baseline titer | 2.3 titer |
| 4CMenB (5/99) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 1 titer (N=25) | 29 titer |
| 4CMenB (5/99) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 2 titer | 144 titer |
| 4CMenB (5/99) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Before dose 3 titer(N=24) | 37 titer |
| 4CMen B (NZ98/254) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Baseline titer | 1.8 titer |
| 4CMen B (NZ98/254) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 1 titer (N=25) | 23 titer |
| 4CMen B (NZ98/254) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Before dose 3 titer(N=24) | 9.4 titer |
| 4CMen B (NZ98/254) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 3 titer (N=39) | 30 titer |
| 4CMen B (NZ98/254) | Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Post dose 2 titer | 32 titer |
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.
Time frame: One month after vaccinations
Population: The analysis was done on the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Injection pain (any) | 52 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Induration (severe) | 0 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Arthralgia (any) | 10 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Myalgia (severe) | 3 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Myalgia (any) | 15 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Nausea (any) | 7 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Arthralgia (severe) | 0 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Analgesic, antipyretic medicine used | 10 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Fever (≥ 38°C) | 2 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Nausea (severe) | 2 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Injection pain (severe) | 8 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Erythema (any) | 22 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Stayed home | 5 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Malaise (any) | 16 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Induration (any) | 23 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Erythema (severe) | 0 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Headache (severe) | 2 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Malaise (severe) | 3 participants |
| 4CMenB (44/76-SL) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Headache (any) | 15 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Malaise (severe) | 1 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Headache (any) | 13 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Myalgia (any) | 19 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Stayed home | 4 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Myalgia (severe) | 3 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Arthralgia (severe) | 0 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Arthralgia (any) | 12 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Erythema (severe) | 0 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Induration (any) | 24 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Injection pain (severe) | 7 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Induration (severe) | 0 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Injection pain (any) | 50 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Fever (≥ 38°C) | 1 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Nausea (any) | 5 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Nausea (severe) | 0 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Headache (severe) | 0 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Malaise (any) | 17 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Erythema (any) | 23 participants |
| 4CMenB (5/99) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Analgesic, antipyretic medicine used | 7 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Fever (≥ 38°C) | 0 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Injection pain (any) | 50 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Injection pain (severe) | 9 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Erythema (any) | 28 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Erythema (severe) | 0 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Induration (any) | 29 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Induration (severe) | 0 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Nausea (any) | 9 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Nausea (severe) | 0 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Malaise (any) | 26 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Malaise (severe) | 2 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Myalgia (any) | 24 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Myalgia (severe) | 7 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Arthralgia (any) | 20 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Arthralgia (severe) | 3 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Headache (any) | 21 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Headache (severe) | 0 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Stayed home | 5 participants |
| 4CMen B (NZ98/254) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Analgesic, antipyretic medicine used | 5 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Malaise (severe) | 1 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Injection pain (severe) | 0 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Headache (any) | 9 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Malaise (any) | 11 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Nausea (severe) | 0 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Injection pain (any) | 10 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Headache (severe) | 1 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Nausea (any) | 4 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Induration (severe) | 0 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Induration (any) | 5 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Fever (≥ 38°C) | 2 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Erythema (severe) | 0 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Erythema (any) | 9 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Analgesic, antipyretic medicine used | 4 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Arthralgia (any) | 6 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Myalgia (severe) | 1 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Stayed home | 2 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Arthralgia (severe) | 0 participants |
| MenACWY-CRM (Y) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | Myalgia (any) | 5 participants |
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: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Time frame: One month after vaccinations
Population: The analysis was done on the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4CMenB (44/76-SL) | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | titers ≥ 4 | 96 percentage |
| 4CMenB (44/76-SL) | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | titers ≥8 | 96 percentage |
| 4CMenB (5/99) | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | titers ≥8 | 96 percentage |
| 4CMenB (5/99) | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | titers ≥ 4 | 100 percentage |
| 4CMen B (NZ98/254) | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | titers ≥ 4 | 100 percentage |
| 4CMen B (NZ98/254) | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | titers ≥8 | 100 percentage |
| MenACWY-CRM (Y) | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | titers ≥ 4 | 83 percentage |
| MenACWY-CRM (Y) | Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | titers ≥8 | 83 percentage |
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: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Time frame: One month after vaccinations
Population: The analysis was done on the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 2) | 100 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Baseline) | 37 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 1) N=25 | 84 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 2) | 100 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Before dose 3) N=24 | 75 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Before dose 3) N=24 | 96 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 3) N=39 | 97 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 3) N=39 | 97 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 1) N=25 | 80 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 1) N=25 | 80 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 2) | 100 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Before dose 3) N=24 | 71 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Baseline) | 26 percentage |
| 4CMenB (44/76-SL) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 3) N=39 | 92 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 1) N=25 | 76 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Before dose 3) N=24 | 75 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Baseline) | 37 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 2) | 100 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 3) N=39 | 100 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 1) N=25 | 88 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Baseline) | 15 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 2) | 100 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 2) | 100 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 3) N=39 | 100 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 1) N=25 | 64 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Before dose 3) N=24 | 100 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 3) N=39 | 100 percentage |
| 4CMenB (5/99) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Before dose 3) N=24 | 100 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 3) N=39 | 92 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 2) | 78 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Baseline) | 15 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 1) N=25 | 72 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 2) | 83 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Before dose 3) N=24 | 54 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥8 (Post dose 3) N=39 | 77 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 1) N=25 | 68 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Before dose 3) N=24 | 46 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | ≥4 fold increase (Post dose 3) N=39 | 69 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Baseline) | 22 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 1) N=25 | 80 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Post dose 2) | 91 percentage |
| 4CMen B (NZ98/254) | Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | titer ≥4 (Before dose 3) N=24 | 67 percentage |