Healthy
Conditions
Keywords
Meningococcal disease, prevention, vaccination
Brief summary
This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.
Interventions
BIOLOGICALrMenB
One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
BIOLOGICALrMenB+OMV
One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
BIOLOGICALDTaP-Hib-IPV
Intramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
BIOLOGICALPC7
IM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
BIOLOGICALMenC-CRM
MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh.
BIOLOGICALMenC-Hib
MenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh.
BIOLOGICALMMR
IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left thigh.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
Subjects eligible to be enrolled in the study: 1. healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg; 2. for whom a parent/legal guardian had provided written informed consent after the nature of the study had been explained; 3. those available for all the visits scheduled in the study; 4. those in good health as determined by: 1. medical history 2. physical examination 3. clinical judgment of the investigator
Exclusion criteria
Individuals were not to be enrolled into the study: 1\. whose parents/legal guardians were unwilling or unable to give written informed consent to participate in the study; 2. who had previously received any meningococcal B vaccine; 3. who had received prior vaccination with Diphtheria Tetanus Pertussis (DTP) (acellular or whole cell), Inactivated Polio Vaccine (IPV) or Oral Polio Vaccine (OPV), H influenzae type b (Hib) or Heptavalent Pneumococcal Conjugate (PC7) vaccine; 4. who had a previous ascertained or suspected disease caused by N meningitidis, S pneumoniae, C diphtheriae, tetani, Poliovirus, Hib, or B pertussis (history of laboratory confirmed, or clinical condition of spasmodic cough for a period ≥2weeks associated with apnea or whooping); 5. who had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis, B pertussis, Hib, C diphtheriae or Polio infection since birth; 6. who had a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 7. who had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (≥38.0°C) within the previous 3 days; 8. who had any present or suspected serious acute or chronic disease (e.g., with signs of cardiac, renal failure, hepatic disease, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome); 9. who had leukemia, lymphomas; 10. who had a known or suspected autoimmune disease or impairment/alteration of immune function resulting from (for example): 1. receipt of any immunosuppressive therapy since birth 2. receipt of immunostimulants since birth 3. receipt of any systemic corticosteroid since birth 11. with a suspected or known HIV infection or HIV related disease; 12. who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation from birth and for the full length of the study; 13. with a known bleeding diathesis, or any condition that might be associated with a prolonged bleeding time; 14. who had experienced any seizure, either associated with fever or as part of an underlying neurological disorder or syndrome 15. who had taken antibiotics within 7 days prior to enrollment (exception: antibiotics taken once daily within 14 days after the last dose); 16. who had either received, or for whom there was intent to immunize with any other vaccine(s), with respect to the study vaccines, within 30 days prior and throughout the study period; 17. who had ever received another investigational agent from birth prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study; 18. whose parents/legal guardians, were planning to leave the area of the study site before the end of the study period; 19. with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | At baseline (pre-vaccination) and 30 days after the third vaccination | Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection. |
| Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Day 1 through day 7 after each vaccination | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3). |
| Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Baseline and one month after third-dose of infants series | Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age. |
| Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Baseline and one month after third-dose of infants series | The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age. |
| Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Day 1 through day 7 after each vaccination | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups). |
| Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Day 1 through day 7 after each vaccination | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3). |
| Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Day 1 through day 7 after each vaccination | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3). |
| Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Day 1 through day 7 after each vaccination | Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only). |
| Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | 30 days after the third vaccination | Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination | Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination. |
| Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | pre-first vaccination and 1 month after first vaccination | Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population. |
| Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | 30 days after the second vaccination and 1 month after fourth (booster) vaccination | Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age. |
| Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | pre-first vaccination and 1 month after first vaccination | Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. |
| Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | 1 month after first vaccination | Geometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age. |
| Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination. | Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age. |
| Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age. | Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population. |
| Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 1 month after first vaccination | Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination. |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects were enrolled at three study centers in the United Kingdom (UK).
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| rMenB Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). | 48 |
| rMenB+OMV Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). | 50 |
| Routine Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age. | 25 |
| Routine+OMV Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age. | 24 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | rMenB | rMenB+OMV | Routine | Routine+OMV | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59.0 Days STANDARD_DEVIATION 3.4 | 60.9 Days STANDARD_DEVIATION 5.9 | 60.4 Days STANDARD_DEVIATION 5.9 | 60.9 Days STANDARD_DEVIATION 6.1 | 60.2 Days STANDARD_DEVIATION 5.3 |
| Sex: Female, Male Female | 24 Participants | 22 Participants | 9 Participants | 7 Participants | 62 Participants |
| Sex: Female, Male Male | 24 Participants | 28 Participants | 16 Participants | 17 Participants | 85 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 | 48 / 48 | 50 / 50 | 25 / 25 | 24 / 24 |
| serious Total, serious adverse events | 3 / 48 | 9 / 50 | 4 / 25 | 2 / 24 |
Outcome results
Primary
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.
Time frame: Baseline and one month after third-dose of infants series
Population: Analysis was performed on the PP set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Baseline | 1.32 titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd dose (N=36,39) | 13 titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Baseline (N=42,43) | 1.22 titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd dose (N=32,37) | 159 titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Baseline (N=46,46) | 1.23 titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd dose (N=37,40) | 1.16 titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Baseline (N=46,46) | 1.15 titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Baseline | 1.4 titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd dose (N=32,37) | 126 titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd dose (N=36,39) | 30 titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd dose (N=37,40) | 19 titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Baseline (N=42,43) | 1.43 titers |
Primary
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.
Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection.
Time frame: At baseline (pre-vaccination) and 30 days after the third vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | Strain 44/76-SL (1 Month After 3rd | 9.89 Ratio |
| rMenB | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | Strain 5/99 (1 Month After 3rd Vacc; | 131 Ratio |
| rMenB | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | Strain NZ98/254 (1 Month After 3rd | 0.91 Ratio |
| rMenB+OMV | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | Strain 44/76-SL (1 Month After 3rd | 21 Ratio |
| rMenB+OMV | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | Strain 5/99 (1 Month After 3rd Vacc; | 91 Ratio |
| rMenB+OMV | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | Strain NZ98/254 (1 Month After 3rd | 16 Ratio |
Primary
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3).
Time frame: Day 1 through day 7 after each vaccination
Population: Analysis was performed on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 1 | 19 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 3 (N=48,48,25,24) | 41 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 3 (N=48,48,25,24) | 23 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 1 | 37 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 3 (N=48,48,25,24) | 12 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 2 (N=48,49,25,24) | 14 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 2 (N=48,49,25,24) | 17 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 2 (N=48,49,25,24) | 42 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 1 | 21 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 2 (N=48,49,25,24) | 44 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 1 | 20 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 3 (N=48,48,25,24) | 42 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 2 (N=48,49,25,24) | 8 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 1 | 22 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 3 (N=48,48,25,24) | 12 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 3 (N=48,48,25,24) | 20 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 2 (N=48,49,25,24) | 16 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 1 | 41 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 2 (N=48,49,25,24) | 25 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 1 | 8 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 2 (N=48,49,25,24) | 5 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 3 (N=48,48,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 1 | 24 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 3 (N=48,48,25,24) | 24 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 1 | 10 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 2 (N=48,49,25,24) | 8 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 3 (N=48,48,25,24) | 13 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 1 | 16 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 1 | 22 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 3 (N=48,48,25,24) | 6 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 3 (N=48,48,25,24) | 15 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Induration - Vaccination 2 (N=48,49,25,24) | 11 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 2 (N=48,49,25,24) | 5 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 3 (N=48,48,25,24) | 23 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Erythema - Vaccination 2 (N=48,49,25,24) | 22 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Tenderness - Vaccination 1 | 14 Number of subjects |
Primary
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3).
Time frame: Day 1 through day 7 after each vaccination
Population: Analysis was performed on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 3 (N=45,48,24,23) | 8 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 3 (N=45,48,24,23) | 21 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 2 (N=48,48,25,24) | 42 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 1 | 37 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 1 | 12 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 2 (N=48,48,25,24) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 2 (N=48,48,25,24) | 13 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 3 (N=45,48,24,23) | 44 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 1 | 7 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 2 (N=48,48,25,24) | 43 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 1 | 8 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 2 (N=48,48,25,24) | 10 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 3 (N=45,48,24,23) | 15 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 1 | 44 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 3 (N=45,48,24,23) | 45 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 1 | 16 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 2 (N=48,48,25,24) | 21 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 3 (N=45,48,24,23) | 24 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 3 (N=45,48,24,23) | 5 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 2 (N=48,48,25,24) | 21 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 2 (N=48,48,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 3 (N=45,48,24,23) | 22 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 1 | 10 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 1 | 7 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 3 (N=45,48,24,23) | 12 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 2 (N=48,48,25,24) | 11 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 1 | 24 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 3 (N=45,48,24,23) | 5 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 1 | 7 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 2 (N=48,48,25,24) | 21 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 1 | 21 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 2 (N=48,48,25,24) | 11 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 2 (N=48,48,25,24) | 6 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Erythema - Vaccination 3 (N=45,48,24,23) | 23 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Tenderness - Vaccination 1 | 5 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Induration - Vaccination 3 (N=45,48,24,23) | 16 Number of subjects |
Primary
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3).
Time frame: Day 1 through day 7 after each vaccination
Population: Analysis was performed on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Tenderness - Vaccination 1 | 19 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Tenderness - Vaccination 3 (N=48,48,25,24) | 10 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Erythema - Vaccination 1 | 38 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Erythema - Vaccination 3 (N=48,48,25,24) | 43 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Induration - Vaccination 1 | 19 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Induration - Vaccination 3 (N=48,48,25,24) | 19 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Induration - Vaccination 3 (N=48,48,25,24) | 19 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Erythema - Vaccination 3 (N=48,48,25,24) | 42 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Tenderness - Vaccination 1 | 21 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Erythema - Vaccination 1 | 43 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Tenderness - Vaccination 3 (N=48,48,25,24) | 12 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Induration - Vaccination 1 | 21 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Tenderness - Vaccination 3 (N=48,48,25,24) | 6 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Erythema - Vaccination 1 | 24 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Erythema - Vaccination 3 (N=48,48,25,24) | 24 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Induration - Vaccination 3 (N=48,48,25,24) | 13 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Induration - Vaccination 1 | 11 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Tenderness - Vaccination 1 | 7 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Induration - Vaccination 1 | 13 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Induration - Vaccination 3 (N=48,48,25,24) | 16 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Tenderness - Vaccination 3 (N=48,48,25,24) | 6 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Erythema - Vaccination 3 (N=48,48,25,24) | 22 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Tenderness - Vaccination 1 | 10 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Erythema - Vaccination 1 | 20 Number of subjects |
Primary
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups).
Time frame: Day 1 through day 7 after each vaccination
Population: Analysis was performed on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 2 (N=48,48,24,23) | 43 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 4 (N=45,48,24,23) | 10 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 3 (N=47,48,24,23) | 20 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 1 | 40 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 2 (N=48,48,24,23) | 13 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 1 | 17 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 2 (N=48,48,24,23) | 10 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 1 | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 4 (N=45,48,24,23) | 43 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 3 (N=47,48,24,23) | 10 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 4 (N=45,48,24,23) | 22 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 3 (N=47,48,24,23) | 43 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 1 | 17 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 2 (N=48,48,24,23) | 14 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 3 (N=47,48,24,23) | 17 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 4 (N=45,48,24,23) | 23 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 1 | 42 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 2 (N=48,48,24,23) | 45 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 3 (N=47,48,24,23) | 44 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 4 (N=45,48,24,23) | 46 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 1 | 24 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 2 (N=48,48,24,23) | 24 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 3 (N=47,48,24,23) | 22 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 4 (N=45,48,24,23) | 34 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 3 (N=47,48,24,23) | 6 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 4 (N=45,48,24,23) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 3 (N=47,48,24,23) | 10 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 2 (N=48,48,24,23) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 4 (N=45,48,24,23) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 4 (N=45,48,24,23) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 3 (N=47,48,24,23) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 1 | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 1 | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 2 (N=48,48,24,23) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 1 | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 2 (N=48,48,24,23) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 1 | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 3 (N=47,48,24,23) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 1 | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 4 (N=45,48,24,23) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 2 (N=48,48,24,23) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 3 (N=47,48,24,23) | 19 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 4 (N=45,48,24,23) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 4 (N=45,48,24,23) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Induration - Vaccination 2 (N=48,48,24,23) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Erythema - Vaccination 1 | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 3 (N=47,48,24,23) | 7 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Tenderness - Vaccination 2 (N=48,48,24,23) | 0 Number of subjects |
Primary
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only).
Time frame: Day 1 through day 7 after each vaccination
Population: Analysis was performed on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 2 (N=48,49,25,24) | 19 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 3 (N=48,48,25,24) | 11 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 2 (N=48,49,25,24) | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 5 (N=47,48,24,23) | 1 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 3 (N=48,48,25,24) | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 2 (N=48,49,25,24) | 26 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 6 (N=45,48,25,24) | 20 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 5 (N=47,48,24,23) | 1 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 4 (N=48,48,25,24) | 5 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 3 (N=48,48,25,24) | 12 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 5 (N=47,48,24,23) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 3 (N=48,48,25,24) | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 5 (N=47,48,24,23) | 5 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 3 (N=48,48,25,24) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 1 (N=48,50,25,23) | 1 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 6 (N=45,48,25,24) | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits - Vaccination 1 | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 2 (N=48,49,25,24) | 0 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 1 | 9 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 3 (N=48,48,25,24) | 23 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 3 (N=48,48,25,24) | 27 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 1 | 34 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 2 (N=48,49,25,24) | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 4 (N=48,48,25,24) | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 6 (N=45,48,25,24) | 16 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 6 (N=45,48,25,24) | 6 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 3 (N=48,48,25,24) | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 2 (N=48,49,25,24) | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 4 (N=48,48,25,24) | 10 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analgesic/Antipyretic Med. Used-Vaccination 1 | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 4 (N=48,48,25,24) | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 5 (N=47,48,24,23) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 2 (N=48,49,25,24) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 1 (N=48,50,25,24) | 10 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 5 (N=47,48,24,23) | 6 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 2 (N=48,49,25,24) | 6 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 4 (N=48,48,25,24) | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 4 (N=48,48,25,24) | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 6 (N=45,48,25,24) | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 6 (N=45,48,25,24) | 11 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 4 (N=48,48,25,24) | 5 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 5 (N=47,48,24,23) | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 6 (N=45,48,25,24) | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 2 (N=48,49,25,24) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 6 (N=45,48,25,24) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 6 (N=45,48,25,24) | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 1 | 32 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 3 (N=48,48,25,24) | 8 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 1 | 11 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 4 (N=48,48,25,24) | 9 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 5 (N=47,48,24,23) | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 4 (N=48,48,25,24) | 5 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 5 (N=47,48,24,23) | 17 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 1 | 13 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 4 (N=48,48,25,24) | 17 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 5 (N=47,48,24,23) | 4 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 6 (N=45,48,25,24) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 3 (N=48,48,25,24) | 7 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 1 | 37 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits - Vaccination 1 | 13 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 2 (N=48,49,25,24) | 29 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 2 (N=48,49,25,24) | 23 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 2 (N=48,49,25,24) | 6 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 3 (N=48,48,25,24) | 34 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 4 (N=48,48,25,24) | 15 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 1 | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 5 (N=47,48,24,23) | 30 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 6 (N=45,48,25,24) | 30 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 2 (N=48,49,25,24) | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 3 (N=48,48,25,24) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 3 (N=48,48,25,24) | 9 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 1 | 9 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analgesic/Antipyretic Med. Used-Vaccination 1 | 29 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 4 (N=48,48,25,24) | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 5 (N=47,48,24,23) | 14 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 6 (N=45,48,25,24) | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 6 (N=45,48,25,24) | 13 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 3 (N=48,48,25,24) | 31 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 1 | 32 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 5 (N=47,48,24,23) | 2 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 2 (N=48,49,25,24) | 17 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 4 (N=48,48,25,24) | 4 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 3 (N=48,48,25,24) | 21 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 5 (N=47,48,24,23) | 7 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 4 (N=48,48,25,24) | 0 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 4 (N=48,48,25,24) | 7 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 2 (N=48,49,25,24) | 6 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 5 (N=47,48,24,23) | 20 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 1 (N=48,50,25,23) | 9 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 1 | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 2 (N=48,49,25,24) | 0 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 6 (N=45,48,25,24) | 8 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 2 (N=48,49,25,24) | 1 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 3 (N=48,48,25,24) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 3 (N=48,48,25,24) | 4 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 1 (N=48,50,25,24) | 2 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 4 (N=48,48,25,24) | 1 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 6 (N=45,48,25,24) | 13 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 5 (N=47,48,24,23) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 6 (N=45,48,25,24) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 6 (N=45,48,25,24) | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 4 (N=48,48,25,24) | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 2 (N=48,49,25,24) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 5 (N=47,48,24,23) | 30 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 5 (N=47,48,24,23) | 10 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 3 (N=48,48,25,24) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 6 (N=45,48,25,24) | 33 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 4 (N=48,48,25,24) | 2 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 5 (N=47,48,24,23) | 10 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 5 (N=47,48,24,23) | 5 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 2 (N=48,49,25,24) | 1 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 3 (N=48,48,25,24) | 2 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 4 (N=48,48,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 2 (N=48,49,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 3 (N=48,48,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 4 (N=48,48,25,24) | 1 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 5 (N=47,48,24,23) | 6 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 1 | 19 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 2 (N=48,49,25,24) | 12 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 3 (N=48,48,25,24) | 6 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 4 (N=48,48,25,24) | 6 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 5 (N=47,48,24,23) | 5 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 1 | 7 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 2 (N=48,49,25,24) | 5 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 3 (N=48,48,25,24) | 1 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 4 (N=48,48,25,24) | 1 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 5 (N=47,48,24,23) | 1 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 1 | 4 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 2 (N=48,49,25,24) | 4 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 3 (N=48,48,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 4 (N=48,48,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 5 (N=47,48,24,23) | 1 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 1 | 17 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 2 (N=48,49,25,24) | 14 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 3 (N=48,48,25,24) | 13 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 4 (N=48,48,25,24) | 7 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits - Vaccination 1 | 11 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 2 (N=48,49,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 3 (N=48,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 4 (N=48,48,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 1 | 8 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 2 (N=48,49,25,24) | 5 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 3 (N=48,48,25,24) | 9 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 4 (N=48,48,25,24) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 5 (N=47,48,24,23) | 3 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 1 (N=48,50,25,24) | 2 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 1 (N=48,50,25,23) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 4 (N=48,48,25,24) | 2 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 5 (N=47,48,24,23) | 4 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analgesic/Antipyretic Med. Used-Vaccination 1 | 10 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 2 (N=48,49,25,24) | 10 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 3 (N=48,48,25,24) | 14 Number of subjects |
| Routine | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 5 (N=47,48,24,23) | 9 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 4 (N=48,48,25,24) | 3 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits - Vaccination 1 | 5 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 4 (N=48,48,25,24) | 2 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 3 (N=48,48,25,24) | 4 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 2 (N=48,49,25,24) | 3 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 5 (N=47,48,24,23) | 10 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 1 | 7 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 5 (N=47,48,24,23) | 3 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 2 (N=48,49,25,24) | 8 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 4 (N=48,48,25,24) | 2 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 3 (N=48,48,25,24) | 1 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 1 (N=48,50,25,24) | 3 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 5 (N=47,48,24,23) | 1 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 2 (N=48,49,25,24) | 2 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 1 | 5 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 3 (N=48,48,25,24) | 2 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 5 (N=47,48,24,23) | 13 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 1 (N=48,50,25,23) | 1 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 2 (N=48,49,25,24) | 1 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 4 (N=48,48,25,24) | 3 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 3 (N=48,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 3 (N=48,48,25,24) | 7 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 3 (N=48,48,25,24) | 10 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 4 (N=48,48,25,24) | 1 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 2 (N=48,49,25,24) | 9 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Sleepiness - Vaccination 1 | 15 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 5 (N=47,48,24,23) | 4 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 5 (N=47,48,24,23) | 4 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 5 (N=47,48,24,23) | 6 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analg. Antipyr. Med. Used-Vaccin 4 (N=48,48,25,24) | 9 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Fever (≥38 °C) - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 4 (N=48,48,25,24) | 1 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 4 (N=48,48,25,24) | 4 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Rash - Vaccination 2 (N=48,49,25,24) | 2 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 5 (N=47,48,24,23) | 13 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 3 (N=48,48,25,24) | 4 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 4 (N=48,48,25,24) | 6 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Vomiting - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 1 | 7 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 3 (N=48,48,25,24) | 12 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 2 (N=48,49,25,24) | 13 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Analgesic/Antipyretic Med. Used-Vaccination 1 | 8 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 2 (N=48,49,25,24) | 1 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Irritability - Vaccination 1 | 15 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 6 (N=45,48,25,24) | 0 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Change in eating habits- Vaccin 2 (N=48,49,25,24) | 1 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Unusual crying - Vaccination 3 (N=48,48,25,24) | 6 Number of subjects |
| Routine+OMV | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Diarrhea - Vaccination 5 (N=47,48,24,23) | 1 Number of subjects |
Primary
Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.
Time frame: Baseline and one month after third-dose of infants series
Population: Analysis was performed on the per protocol (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Strain 44/76-SL - Titer ≥1:4 - Baseline | 11 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Str. 44/76-SL-Titer ≥1:4- Post-3rd dose (N=36,39) | 78 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Strain 5/99 - Titer ≥1:4 - Baseline (N=42,43) | 7 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Str. 5/99 - Titer ≥1:4- Post-3rd dose (N=32,37) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Strain NZ98/254 - Titer ≥1:4 - Baseline (N=46,46) | 4 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Str. NZ98/254-Titer ≥1:4- Post-3rd dose (N=37,40) | 5 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Strain NZ98/254 - Titer ≥1:4 - Baseline (N=46,46) | 9 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Strain 44/76-SL - Titer ≥1:4 - Baseline | 11 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Str. 5/99 - Titer ≥1:4- Post-3rd dose (N=32,37) | 95 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Str. 44/76-SL-Titer ≥1:4- Post-3rd dose (N=36,39) | 87 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Str. NZ98/254-Titer ≥1:4- Post-3rd dose (N=37,40) | 85 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Strain 5/99 - Titer ≥1:4 - Baseline (N=42,43) | 14 Percentage of subjects |
Primary
Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.
Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.
Time frame: 30 days after the third vaccination
Population: Analysis was performed on the Per Protocol Set (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | Str. 5/99-SL 4-fold Rise-Post-3rd dose (N=32,37) | 97 Percentage of Subjects |
| rMenB | Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | Str. 44/76-SL 4-fold Rise-Post-3rd dose (N=36,39) | 69 Percentage of Subjects |
| rMenB | Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | Str. NZ98/254-4-fold Rise-Post-3rd dose (N=37,40) | 3 Percentage of Subjects |
| rMenB+OMV | Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | Str. 44/76-SL 4-fold Rise-Post-3rd dose (N=36,39) | 85 Percentage of Subjects |
| rMenB+OMV | Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | Str. 5/99-SL 4-fold Rise-Post-3rd dose (N=32,37) | 92 Percentage of Subjects |
| rMenB+OMV | Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | Str. NZ98/254-4-fold Rise-Post-3rd dose (N=37,40) | 78 Percentage of Subjects |
Secondary
Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination
Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age.
Time frame: 30 days after the second vaccination and 1 month after fourth (booster) vaccination
Population: Analysis was performed on the PP set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) | 4.36 ratios |
| rMenB | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) | 104 ratios |
| rMenB | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38) | 0.92 ratios |
| rMenB | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | 44/76-SL (1 month after booster; N=38, 31) | 42 ratios |
| rMenB | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | 5/99 (1 month after booster; N=34, 30) | 217 ratios |
| rMenB | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | NZ98/254 (1 month after booster; N=39, 31) | 0.85 ratios |
| rMenB+OMV | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | 5/99 (1 month after booster; N=34, 30) | 467 ratios |
| rMenB+OMV | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) | 19 ratios |
| rMenB+OMV | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | 44/76-SL (1 month after booster; N=38, 31) | 78 ratios |
| rMenB+OMV | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) | 71 ratios |
| rMenB+OMV | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | NZ98/254 (1 month after booster; N=39, 31) | 28 ratios |
| rMenB+OMV | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38) | 5.55 ratios |
Secondary
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age
Geometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age.
Time frame: 1 month after first vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | 5/99 (1 month after first Vacc; N=21, 22) | 73 Ratio |
| rMenB | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | 44/76-SL (1 month after first Vacc; N=22, 22) | 1.51 Ratio |
| rMenB | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | NZ98/254 (1 month after first Vacc; N=21, 22) | 0.97 Ratio |
| rMenB+OMV | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | 44/76-SL (1 month after first Vacc; N=22, 22) | 3.21 Ratio |
| rMenB+OMV | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | 5/99 (1 month after first Vacc; N=21, 22) | 8 Ratio |
| rMenB+OMV | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | NZ98/254 (1 month after first Vacc; N=21, 22) | 1.66 Ratio |
Secondary
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ
Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population.
Time frame: pre-first vaccination and 1 month after first vaccination
Population: Analysis was performed on the PP set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | 5/99 (pre-vaccination; N=21,22) | 1 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | 44/76-SL (1 month after first Vacc; N=22,22) | 2.34 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | 5/99 (1 month after first Vacc; N=21,22) | 73 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | 44/76-SL (pre-vaccination; N=22,22) | 1.55 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | NZ98/254 (1 month after first Vacc; N=21, 22) | 1 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | NZ98/254 (pre-vaccination; N=21, 22) | 1.03 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | NZ98/254 (1 month after first Vacc; N=21, 22) | 1.66 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | 44/76-SL (pre-vaccination; N=22,22) | 1.88 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | 5/99 (pre-vaccination; N=21,22) | 1 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | NZ98/254 (pre-vaccination; N=21, 22) | 1 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | 5/99 (1 month after first Vacc; N=21,22) | 8 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | 44/76-SL (1 month after first Vacc; N=22,22) | 6.02 titers |
Secondary
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination.
Time frame: prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination
Population: Analysis was performed on the PP set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain 44/76-SL (pre-vaccination; N=45, 45) | 1.32 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain 5/99 (pre-vaccination; N=42, 43) | 1.22 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain NZ98/254 (pre-vaccination; N=46, 46) | 1.23 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) | 5.96 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) | 119 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38) | 1.13 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | 44/76-SL (6 months after pre-booster; N=40, 44) | 5.46 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | 5/99 (6 months after pre-booster; N=37, 40) | 37 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | NZ98/254 (6 months after pre-booster; N=41, 44) | 1.14 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | 44/76-SL (1 month after booster; N=38, 31) | 56 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | 5/99 (1 month after booster; N=34, 30) | 261 titers |
| rMenB | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | NZ98/254 (1 month after booster; N=39, 31) | 1.09 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | 5/99 (1 month after booster; N=34, 30) | 691 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain 44/76-SL (pre-vaccination; N=45, 45) | 1.4 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | 44/76-SL (6 months after pre-booster; N=40, 44) | 5.07 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain 5/99 (pre-vaccination; N=42, 43) | 1.43 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | 44/76-SL (1 month after booster; N=38, 31) | 114 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain NZ98/254 (pre-vaccination; N=46, 46) | 1.15 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | 5/99 (6 months after pre-booster; N=37, 40) | 21 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) | 28 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | NZ98/254 (1 month after booster; N=39, 31) | 33 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) | 104 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | NZ98/254 (6 months after pre-booster; N=41, 44) | 2.38 titers |
| rMenB+OMV | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38) | 6.55 titers |
Secondary
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination.
Time frame: pre-first vaccination and 1 month after first vaccination
Population: Analysis was performed on the PP set after booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | 44/76-SL (1 month after first Vacc; N=22,22) | 32 Percentage of subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | 5/99 (12 Months of Age, pre-first vacc; N=21,22) | 0 Percentage of subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | 5/99 (1 month after first Vacc; N=21,22) | 100 Percentage of subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | 44/76-SL (12 Months Age, pre-first vacc; N=22,22) | 9 Percentage of subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | NZ98/254 (1 month after first Vacc; N=21, 22) | 0 Percentage of subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | NZ98/254 (12 Months Age, pre-first vacc; N=21,22) | 0 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | NZ98/254 (1 month after first Vacc; N=21, 22) | 18 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | 44/76-SL (12 Months Age, pre-first vacc; N=22,22) | 18 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | 5/99 (12 Months of Age, pre-first vacc; N=21,22) | 0 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | 44/76-SL (1 month after first Vacc; N=22,22) | 73 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | 5/99 (1 month after first Vacc; N=21,22) | 73 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | NZ98/254 (12 Months Age, pre-first vacc; N=21,22) | 0 Percentage of subjects |
Secondary
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population.
Time frame: At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 44/76-SL (Pre-Vaccination; N=45, 45) | 11 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 5/99 (Pre-vaccination; N=42, 43) | 7 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 5/99 (6 months after prebooster; N=37, 40) | 92 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | 5/99 (1 month after booster; N=34, 30) | 97 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | NZ98/254 (1 month after booster; N=39, 31) | 3 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain NZ98/254 Pre-Vaccination; N=46, 46) | 4 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) | 58 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) | 89 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38 | 5 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | 44/76-SL (6 months after pre-booster; N=40, 44) | 70 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | NZ98/254 (6 months after pre-booster; N=41, 44) | 5 Percentages of Subjects |
| rMenB | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | 44/76-SL (1 month after booster; N=38, 31) | 100 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain NZ98/254 Pre-Vaccination; N=46, 46) | 9 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 44/76-SL (Pre-Vaccination; N=45, 45) | 11 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38 | 74 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 5/99 (Pre-vaccination; N=42, 43) | 14 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) | 95 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 5/99 (6 months after prebooster; N=37, 40) | 88 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | 44/76-SL (1 month after booster; N=38, 31) | 100 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | NZ98/254 (6 months after pre-booster; N=41, 44) | 36 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | 5/99 (1 month after booster; N=34, 30) | 97 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) | 100 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | NZ98/254 (1 month after booster; N=39, 31) | 94 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | 44/76-SL (6 months after pre-booster; N=40, 44) | 68 Percentages of Subjects |
Secondary
Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination.
Time frame: 1 month after first vaccination
Population: Analysis was performed on the PP set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 44/76-SL (1 month after first Vacc; N=22, 22) | 14 Percentage of subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 5/99 (1 month after first Vacc; N=21, 22) | 100 Percentage of subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | NZ98/254 (1 month after first Vacc; N=21, 22) | 0 Percentage of subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 44/76-SL (1 month after 4th (booster); N=37, 30) | 92 Percentage of subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 5/99 (1 month after 4th (booster); N=33, 27) | 97 Percentage of subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | NZ98/254 (1 month after 4th (booster); N=38, 29) | 0 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 5/99 (1 month after 4th (booster); N=33, 27) | 97 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 44/76-SL (1 month after first Vacc; N=22, 22) | 36 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 44/76-SL (1 month after 4th (booster); N=37, 30) | 93 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | 5/99 (1 month after first Vacc; N=21, 22) | 59 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | NZ98/254 (1 month after 4th (booster); N=38, 29) | 76 Percentage of subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | NZ98/254 (1 month after first Vacc; N=21, 22) | 9 Percentage of subjects |
Secondary
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age.
Time frame: At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) | 89 Percentages of Subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | NZ98/254 (6 months after pre-booster; N=41, 44) | 2 Percentages of Subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | 44/76-SL (6 months after pre-booster; N=40, 44) | 45 Percentages of Subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | 44/76-SL (1 month after 4th (booster); N=37, 30) | 92 Percentages of Subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | Strain NZ98/254 (1 Month After 2nd Vacc N=41, 38) | 2 Percentages of Subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | 5/99 (1 month after 4th (booster); N=33, 27) | 95 Percentages of Subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | 5/99 (6 months after pre-booster; N=37, 40) | 84 Percentages of Subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | NZ98/254 (1 month after 4th (booster); N=38, 29) | 0 Percentages of Subjects |
| rMenB | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) | 50 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | NZ98/254 (1 month after 4th (booster); N=38, 29) | 76 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) | 86 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) | 94 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | Strain NZ98/254 (1 Month After 2nd Vacc N=41, 38) | 55 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | 44/76-SL (6 months after pre-booster; N=40, 44) | 41 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | 5/99 (6 months after pre-booster; N=37, 40) | 65 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | NZ98/254 (6 months after pre-booster; N=41, 44) | 23 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | 44/76-SL (1 month after 4th (booster); N=37, 30) | 93 Percentages of Subjects |
| rMenB+OMV | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | 5/99 (1 month after 4th (booster); N=33, 27) | 97 Percentages of Subjects |