Meningococcal Disease, Meningococcal Meningitis
Conditions
Keywords
Meningococcal disease, Vaccines, intercalated administration
Brief summary
The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age. This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule.
Interventions
BIOLOGICALrMenB + OMV NZ vaccine
3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
BIOLOGICALMeningococcal C oligosaccharide conjugated vaccine
Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
BIOLOGICALPneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
71 Days to 10 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infants and children according to the following age groups: * Healthy infants 2½ months of age (71 -79 days, inclusive), (only applicable to group I) * Healthy infants 3½ months of age (101 -109 days, inclusive), (only applicable to group II) * Healthy infants 6 months of age (only applicable to group III) (The age window is defined as the first day the subject turns 6 months of age up to the day before the subject turns 7 months of age). * Healthy children 2 to 5 years of age (only applicable to group IVa) (The age window is defined as the first day the subject turns 2 years of age up to the day before the subject turns 6 years of age). * Healthy children 6 to 10 years of age (only applicable to group IVb) (The age window is defined as the first day the subject turns 6 years of age up to the day before the subject turns 11 years of age). * Healthy infants 3 months of age (83-104 days, inclusive), (only applicable to Group V and VI). 2. For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained; 3. Available for all the visits scheduled in the study; 4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion criteria
1. Individuals whose parent(s)/legal guardian(s) are unwilling or unable to give written informed consent to participate in the study; 2. Children's parents or legal guardian who are not able to comprehend and to follow all required study procedures for the whole period of the study. 3. History of any meningococcal B vaccine administration; 4. Previous ascertained or suspected disease caused by N. meningitidis; 5. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 6. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component 7. Significant acute or chronic infection within the previous 7 days or temperature 38° C within the previous day of receiving the study vaccine; 8. Antibiotics treatment within 6 days prior to enrollment; 9. Individuals with history of allergy to vaccine components. 10. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 11. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of high dose systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 14 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion); 12. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment. 13. Receipt of, or intent to immunize with, any other vaccine(s) within 7 days prior to enrollment. 14. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 15. Family members and household members of research staff 16. Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. 17. History of any meningococcal C vaccine administration (Only applicable to group V and VI). 18. History of any Pneumococcal vaccine administration (Only applicable to group V and VI).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | 1 month after second vaccination | Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | 1 month after second vaccination | Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS-primary series. |
| Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | 1 month after second vaccination | Immunogenicity was assessed in terms of percentages of subjects achieving 4-fold increase in hSBA titers as compared to baseline against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS- primary series. |
| Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | 1 month after primary series vaccination | Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains following 2 or 3 dose primary series of vaccination rMenB+OMV NZ (1 month after 3rd infant vaccination in B\_2h3h5\_11 and 1 month after 2nd infant vaccination in B\_3h5\_11, B\_68\_11 and B\_02). Analysis was done on FAS-primary series. |
| Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | 1, 1.5 or 2 months after first infant vaccination | Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains after the first infant vaccination in groups B\_2h3h5\_11b, B\_3h5\_11b and B\_68\_11b (after 1 month for group B\_2h3h5\_11b, 1.5 months for group B\_2h3h5\_11b and 2 months for group B\_68\_11b). Analysis was done on FAS-post first dose. |
| Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination) | Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 after the first infant vaccination in groups B\_2h3h5\_11b, B\_3h5\_11b and B\_68\_11b (at 3.5, 5, and 8 months of age respectively). Analysis was done on FAS-post first dose. |
| Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | 1 month post-booster dose | Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following a booster dose of rMenB+OMV NZ given at 11 months of age (4th dose for B\_2h3h5\_11 and 3rd dose for B\_3h5\_11 and B\_68\_11). Analysis was done on FAS-booster. |
| Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 11 months of age (persistence) | Persistence of bactericidal antibodies at 11 months of age was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ vaccine. Analysis was done on FAS-persistence. |
| Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 11 months of age (persistence) | Persistence of bactericidal antibodies at 11 months of age was assessed in terms of GMTs against N meningitidis serogroup B indicator strains in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ. Analysis was done on FAS-persistence. |
| Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | 1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination | Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, following 2 or 3 dose primary series and booster dose of rMenB+OMV NZ. Analysis was done on FAS-persistence and FAS-booster. |
| Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age | 1 month after second vaccination | Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, after a two dose catch-up immunization series with rMenB+OMV NZ in children 2-10 years of age. Analysis was done on FAS-primary series. |
| Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | Baseline, 1 month after second vaccination and 1 month after booster vaccination | Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months, as measured by the percentages of subjects achieving hSBA titers ≥ 8 against serogroup C. Analysis was done on PPS-primary series and PPS-booster. |
| GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | 1 month after second vaccination, 1 month after booster vaccination | Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary series and FAS-booster. |
| GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence | Pre-booster vaccination (persistence; 12 months of age) | Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence. |
| Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | 1 month after third vaccination | Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713, following 3-dose primary series of vaccination with rMenB+OMV NZ at 2.5, 3.5 and 5 months of age. Analysis was done on FAS-primary series. |
| GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination | Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence and FAS-booster. |
| Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination | Immunogenicity was assessed in terms of Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary and FAS-booster. |
| Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence | Pre-booster vaccination (persistence; 12 months of age) | Immunogenicity was assessed in terms of GMTs against Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence. |
| Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Within 30 minutes after any vaccination | Safety was assessed in terms of number of subjects who reported immediate reactions within 30 minutes following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set. |
| Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Day 1 to day 7 after any vaccination | Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or as a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set. |
| Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Within 30 minutes after any vaccination | Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2 - 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set. |
| Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Day 1 to day 7 after any vaccination | Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2- 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set. |
| Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Within 30 minutes after any vaccination | Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set. |
| Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Day 1 to day 7 after any vaccination | Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set. |
| Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | Until 12 months of age; Day 1 to day 7 (All AEs) | Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV. Analysis was done on unsolicited safety set. |
| Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs) | Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ. Analysis was done on unsolicited safety set. |
| Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs) | Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on unsolicited safety set. |
| Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 1 month after second vaccination and 1 month after booster vaccination | Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and a booster at 12 months. Analysis was done on FAS-primary series and FAS-booster. |
Countries
Brazil, Hungary, Peru, Spain
Participant flow
Recruitment details
The study was conducted in a total of a total of 26 sites; 4 sites in Brazil, 3 sites in Peru, 10 sites in Hungary, 9 sites in Spain.
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| B_2h3h5_11 Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. | 253 |
| B_3h5_11 Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. | 250 |
| B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. | 251 |
| B_02_2_5 Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. | 104 |
| B_02_6_10 Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. | 300 |
| BC_35_12 Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age. | 126 |
| C_35_12 Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age. | 125 |
| TOTAL Total of all reporting groups | 1,409 |
| Total | 2,818 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Inappropriate Enrollment | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 4 | 0 | 3 | 1 | 1 | 5 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 3 | 1 |
| Overall Study | Unable to Classify | 1 | 0 | 1 | 0 | 0 | 1 | 5 |
| Overall Study | Withdrawal by Subject | 7 | 11 | 6 | 1 | 4 | 3 | 2 |
Baseline characteristics
| Characteristic | B_2h3h5_11 | B_3h5_11 | B_68_11 | B_02_2_5 | B_02_6_10 | BC_35_12 | C_35_12 | TOTAL |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 2.0 month STANDARD_DEVIATION 0.1 | 3.0 month STANDARD_DEVIATION 0.1 | 6.0 month STANDARD_DEVIATION 0 | 47.5 month STANDARD_DEVIATION 13.4 | 96.9 month STANDARD_DEVIATION 16.8 | 3.0 month STANDARD_DEVIATION 0.2 | 3.0 month STANDARD_DEVIATION 0.1 | 26.6 month STANDARD_DEVIATION 39.3 |
| Sex: Female, Male Female | 117 Participants | 124 Participants | 127 Participants | 49 Participants | 149 Participants | 74 Participants | 59 Participants | 699 Participants |
| Sex: Female, Male Male | 136 Participants | 126 Participants | 124 Participants | 55 Participants | 151 Participants | 52 Participants | 66 Participants | 710 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 246 / 252 | 240 / 249 | 245 / 250 | 100 / 104 | 288 / 300 | 124 / 126 | 115 / 123 | 1,358 / 1,404 |
| serious Total, serious adverse events | 15 / 252 | 18 / 249 | 9 / 250 | 1 / 104 | 2 / 300 | 5 / 126 | 8 / 123 | 58 / 1,404 |
Outcome results
Primary
Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination.
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.
Time frame: 1 month after second vaccination
Population: FAS-Primary series
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | H44/76 (hSBA≥ 4; N=228, 234)) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | 5/99 (hSBA≥ 4) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | NZ98/254 (hSBA≥ 4; N=230, 233) | 98 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | M10713 (hSBA≥ 5; N=181, 192)) | 44 Percentages of subjects |
| B_68_11 | Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | M10713 (hSBA≥ 5; N=181, 192)) | 73 Percentages of subjects |
| B_68_11 | Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | H44/76 (hSBA≥ 4; N=228, 234)) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | NZ98/254 (hSBA≥ 4; N=230, 233) | 99 Percentages of subjects |
| B_68_11 | Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. | 5/99 (hSBA≥ 4) | 100 Percentages of subjects |
Secondary
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ
Persistence of bactericidal antibodies at 11 months of age was assessed in terms of GMTs against N meningitidis serogroup B indicator strains in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ. Analysis was done on FAS-persistence.
Time frame: 11 months of age (persistence)
Population: FAS-persistence
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B_3h5_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (Baseline; N=113,112,120) | 1.15 Titers |
| B_3h5_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (11 moa; N=199,177,188) | 2.55 Titers |
| B_3h5_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 (11 moa; N=233,233,238) | 4.57 Titers |
| B_3h5_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (11 moa; N=234,230,235) | 98 Titers |
| B_3h5_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 (Baseline; N=113,113,122) | 1.07 Titers |
| B_3h5_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (11 moa; N=235,232,237)) | 12 Titers |
| B_3h5_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (Baseline; N=111,113,120) | 1.31 Titers |
| B_3h5_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (Baseline; N=84,64,88) | 2.36 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (11 moa; N=234,230,235) | 50 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 (Baseline; N=113,113,122) | 1.04 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (Baseline; N=111,113,120) | 1.34 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (11 moa; N=235,232,237)) | 12 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (Baseline; N=113,112,120) | 1.16 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 (11 moa; N=233,233,238) | 2.68 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (Baseline; N=84,64,88) | 1.52 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (11 moa; N=199,177,188) | 1.98 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (Baseline; N=111,113,120) | 1.58 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 (11 moa; N=233,233,238) | 12 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (11 moa; N=235,232,237)) | 67 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (11 moa; N=199,177,188) | 3.62 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (Baseline; N=84,64,88) | 1.29 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (11 moa; N=234,230,235) | 285 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 (Baseline; N=113,113,122) | 1 Titers |
| B_68_11 | Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (Baseline; N=113,112,120) | 0.97 Titers |
Secondary
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ
Persistence of bactericidal antibodies at 11 months of age was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ vaccine. Analysis was done on FAS-persistence.
Time frame: 11 months of age (persistence)
Population: FAS-persistence
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (hSBA≥ 4; 11 months of age; N=235,232,237) | 87 Percentages of subjects |
| B_3h5_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (hSBA≥ 4; 11 months of age; N=234,230,235) | 100 Percentages of subjects |
| B_3h5_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 hSBA≥ 4; 11 months of age; N=233,233,238) | 54 Percentages of subjects |
| B_3h5_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (hSBA≥ 5; 11 months of age; N=199,177,188) | 33 Percentages of subjects |
| B_3h5_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (hSBA≥ 8; 11 months of age; N=235,232,237) | 64 Percentages of subjects |
| B_3h5_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (hSBA≥ 8; 11 months of age; N=234,230,235) | 94 Percentages of subjects |
| B_3h5_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 hSBA≥ 8; 11 months of age; N=233,233,238) | 36 Percentages of subjects |
| B_3h5_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (hSBA≥ 8; 11 months of age; N=199,177,188) | 24 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 hSBA≥ 4; 11 months of age; N=233,233,238) | 41 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 hSBA≥ 8; 11 months of age; N=233,233,238) | 12 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (hSBA≥ 5; 11 months of age; N=199,177,188) | 23 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (hSBA≥ 8; 11 months of age; N=235,232,237) | 60 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (hSBA≥ 8; 11 months of age; N=234,230,235) | 87 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (hSBA≥ 4; 11 months of age; N=235,232,237) | 86 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (hSBA≥ 4; 11 months of age; N=234,230,235) | 93 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (hSBA≥ 8; 11 months of age; N=199,177,188) | 16 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 hSBA≥ 4; 11 months of age; N=233,233,238) | 90 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (hSBA≥ 4; 11 months of age; N=234,230,235) | 100 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (hSBA≥ 4; 11 months of age; N=235,232,237) | 100 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (hSBA≥ 5; 11 months of age; N=199,177,188) | 42 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | NZ98/254 hSBA≥ 8; 11 months of age; N=233,233,238) | 65 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | 5/99 (hSBA≥ 8; 11 months of age; N=234,230,235) | 99 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | H44/76 (hSBA≥ 8; 11 months of age; N=235,232,237) | 96 Percentages of subjects |
| B_68_11 | Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ | M10713 (hSBA≥ 8; 11 months of age; N=199,177,188) | 36 Percentages of subjects |
Secondary
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age
Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, after a two dose catch-up immunization series with rMenB+OMV NZ in children 2-10 years of age. Analysis was done on FAS-primary series.
Time frame: 1 month after second vaccination
Population: FAS-primary series
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| B_3h5_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age | 2333 IU/mL |
Secondary
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ
Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, following 2 or 3 dose primary series and booster dose of rMenB+OMV NZ. Analysis was done on FAS-persistence and FAS-booster.
Time frame: 1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination
Population: FAS-persistence and FAS-booster
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B_3h5_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | Pre-booster vaccination (N=213,220,215) | 474 IU/mL |
| B_3h5_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | 1 month after primary vaccination (N=212,215,212) | 4688 IU/mL |
| B_3h5_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | 1 month after booster dose | 5900 IU/mL |
| B_68_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | Pre-booster vaccination (N=213,220,215) | 291 IU/mL |
| B_68_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | 1 month after primary vaccination (N=212,215,212) | 3152 IU/mL |
| B_68_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | 1 month after booster dose | 6062 IU/mL |
| B_68_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | 1 month after primary vaccination (N=212,215,212) | 4682 IU/mL |
| B_68_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | 1 month after booster dose | 5898 IU/mL |
| B_68_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ | Pre-booster vaccination (N=213,220,215) | 1270 IU/mL |
Secondary
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Immunogenicity was assessed in terms of Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary and FAS-booster.
Time frame: 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
Population: FAS-primary and FAS-booster
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B_3h5_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 1 month after 2nd vacc | 2125 IU/mL |
| B_3h5_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | Pre-booster vacc (N=111) | 194 IU/mL |
| B_3h5_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 1 month after booster vacc (N=113) | 4281 IU/mL |
Secondary
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence
Immunogenicity was assessed in terms of GMTs against Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.
Time frame: Pre-booster vaccination (persistence; 12 months of age)
Population: FAS-persistence
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| B_3h5_11 | Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence | 196 IU/mL |
Secondary
Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV.
Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains after the first infant vaccination in groups B\_2h3h5\_11b, B\_3h5\_11b and B\_68\_11b (after 1 month for group B\_2h3h5\_11b, 1.5 months for group B\_2h3h5\_11b and 2 months for group B\_68\_11b). Analysis was done on FAS-post first dose.
Time frame: 1, 1.5 or 2 months after first infant vaccination
Population: FAS-post first dose
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B_3h5_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | H44/76 1 month after 1st vacc; N=117,115,117 | 4.19 Titers |
| B_3h5_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | 5/99 1 month after 1st vacc | 20 Titers |
| B_3h5_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | NZ98/254 1 month after 1st vacc; N=118,114,117 | 2.87 Titers |
| B_3h5_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | M10713 1 month after 1st vacc; N=95,99,95 | 2.59 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | M10713 1 month after 1st vacc; N=95,99,95 | 1.69 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | H44/76 1 month after 1st vacc; N=117,115,117 | 5.7 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | NZ98/254 1 month after 1st vacc; N=118,114,117 | 2.48 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | 5/99 1 month after 1st vacc | 30 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | M10713 1 month after 1st vacc; N=95,99,95 | 1.62 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | 5/99 1 month after 1st vacc | 37 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | NZ98/254 1 month after 1st vacc; N=118,114,117 | 2.84 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. | H44/76 1 month after 1st vacc; N=117,115,117 | 9.83 Titers |
Secondary
Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV
Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains following 2 or 3 dose primary series of vaccination rMenB+OMV NZ (1 month after 3rd infant vaccination in B\_2h3h5\_11 and 1 month after 2nd infant vaccination in B\_3h5\_11, B\_68\_11 and B\_02). Analysis was done on FAS-primary series.
Time frame: 1 month after primary series vaccination
Population: FAS-primary series
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B_3h5_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | H44/76 (1 month after primary vacc; N=237,228,234, | 109 Titers |
| B_3h5_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | 5/99 (1 month after primary vacc) | 795 Titers |
| B_3h5_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | NZ98/254 1m after primary vacc; N=238,230,233,389 | 34 Titers |
| B_3h5_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | M10713 1 m after primary vacc; N=197,181,192,370 | 4.86 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | 5/99 (1 month after primary vacc) | 605 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | NZ98/254 1m after primary vacc; N=238,230,233,389 | 39 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | M10713 1 m after primary vacc; N=197,181,192,370 | 3.39 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | H44/76 (1 month after primary vacc; N=237,228,234, | 132 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | NZ98/254 1m after primary vacc; N=238,230,233,389 | 65 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | 5/99 (1 month after primary vacc) | 1157 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | M10713 1 m after primary vacc; N=197,181,192,370 | 9.96 Titers |
| B_68_11 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | H44/76 (1 month after primary vacc; N=237,228,234, | 240 Titers |
| B_02 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | M10713 1 m after primary vacc; N=197,181,192,370 | 35 Titers |
| B_02 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | 5/99 (1 month after primary vacc) | 489 Titers |
| B_02 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | H44/76 (1 month after primary vacc; N=237,228,234, | 121 Titers |
| B_02 | Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV | NZ98/254 1m after primary vacc; N=238,230,233,389 | 42 Titers |
Secondary
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence and FAS-booster.
Time frame: 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
Population: FAS-persistence and FAS-booster
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 5/99 (Pre-booster vacc) | 55 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | H44/76 (1 month after 2nd vacc) | 226 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | H44/76 (Pre-booster vacc) | 16 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | H44/76 (1 month after booster vacc; N=114) | 239 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 5/99 (1 month after 2nd vacc) | 555 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 5/99 (1 month after booster vacc; N=113) | 1623 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | NZ98/254 (1 month after 2nd vacc; N=114) | 27 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | NZ98/254 (Pre-booster vacc; N=115) | 2.63 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | NZ98/254 (1 month after booster vacc; N=114) | 68 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | M10713 (1 month after 2nd vacc; N=89) | 9.81 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | M10713 (Pre-booster vacc; N=110) | 2.2 Titers |
| B_3h5_11 | GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | M10713 (1 month after booster vacc; N=101) | 11 Titers |
Secondary
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone
Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary series and FAS-booster.
Time frame: 1 month after second vaccination, 1 month after booster vaccination
Population: FAS-primary series and FAS-booster
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B_3h5_11 | GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | 1 month after 2nd vacc | 568 Titers |
| B_3h5_11 | GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | Pre-booster vacc (N=92,75) | 36 Titers |
| B_3h5_11 | GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | 1 month after booster vacc (N=99,92) | 1201 Titers |
| B_68_11 | GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | 1 month after 2nd vacc | 905 Titers |
| B_68_11 | GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | Pre-booster vacc (N=92,75) | 56 Titers |
| B_68_11 | GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | 1 month after booster vacc (N=99,92) | 1724 Titers |
Secondary
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence
Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.
Time frame: Pre-booster vaccination (persistence; 12 months of age)
Population: FAS-persistence
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| B_3h5_11 | GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence | 36 Titers |
| B_68_11 | GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence | 56 Titers |
Secondary
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12
Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on unsolicited safety set.
Time frame: Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs)
Population: Unsolicited safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | At least possibly related SAEs | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | All AEs (days 1-7) | 103 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | Medically attended AEs | 99 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | AEs leading to premature withdrawal | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | SAEs | 5 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | Deaths | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | At least possibly related AEs | 14 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | Deaths | 0 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | All AEs (days 1-7) | 90 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | At least possibly related AEs | 12 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | SAEs | 7 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | At least possibly related SAEs | 0 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | AEs leading to premature withdrawal | 0 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 | Medically attended AEs | 85 Number of subjects |
Secondary
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10
Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ. Analysis was done on unsolicited safety set.
Time frame: Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)
Population: Unsolicited safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | SAEs | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | Medically attended AEs | 42 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | At least possible related AEs | 16 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | AEs leading to premature withdrawal | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | At least possibly related SAEs | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | Deaths | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | All AEs (days 1-7) | 58 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | Deaths | 0 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | All AEs (days 1-7) | 101 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | At least possible related AEs | 24 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | SAEs | 2 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | At least possibly related SAEs | 0 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | Medically attended AEs | 74 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 | AEs leading to premature withdrawal | 0 Number of subjects |
Secondary
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11
Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV. Analysis was done on unsolicited safety set.
Time frame: Until 12 months of age; Day 1 to day 7 (All AEs)
Population: Unsolicited safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | At least possible related AEs | 88 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | Medically attended AEs | 178 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | At least possibly related SAEs | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | All AEs (days 1-7) | 200 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | Deaths | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | AEs leading to premature withdrawal | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | SAEs | 15 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | At least possibly related SAEs | 1 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | All AEs (days 1-7) | 186 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | At least possible related AEs | 41 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | SAEs | 18 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | Medically attended AEs | 179 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | AEs leading to premature withdrawal | 1 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | Deaths | 0 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | Medically attended AEs | 182 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | At least possible related AEs | 62 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | Deaths | 0 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | AEs leading to premature withdrawal | 0 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | At least possibly related SAEs | 1 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | SAEs | 9 Number of subjects |
| B_68_11 | Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 | All AEs (days 1-7) | 196 Number of subjects |
Secondary
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.
Time frame: Within 30 minutes after any vaccination
Population: Solicited safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Tenderness (rMenB+OMV NZ) (N=126,0) | 7 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Erythema (rMenB+OMV NZ) (N=126,0) | 3 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Induration (rMenB+OMV NZ) (N=126,0) | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Swelling (rMenB+OMV NZ) (N=126,0) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Tenderness (MenC-CRM) | 5 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Erythema (MenC-CRM) | 4 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Induration (MenC-CRM) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Swelling (MenC-CRM) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Change in eating habits | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Sleepiness | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Unusual crying | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Irritability | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Vomiting | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Diarrhea | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Rash | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Fever (≥38°C) | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used for pain | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used to prevent high temp. | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used to treat high temp. | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medically-attended fever | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used to prevent high temp. | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Tenderness (rMenB+OMV NZ) (N=126,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Unusual crying | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Erythema (rMenB+OMV NZ) (N=126,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Fever (≥38°C) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Induration (rMenB+OMV NZ) (N=126,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Irritability | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Swelling (rMenB+OMV NZ) (N=126,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medically-attended fever | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Tenderness (MenC-CRM) | 5 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Vomiting | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Erythema (MenC-CRM) | 5 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used for pain | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Induration (MenC-CRM) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Diarrhea | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Swelling (MenC-CRM) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used to treat high temp. | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Change in eating habits | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Rash | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination | Sleepiness | 0 Number of subjects |
Secondary
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2 - 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.
Time frame: Within 30 minutes after any vaccination
Population: Solicited safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Pain | 6 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Erythema | 6 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Induration | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Swelling | 2 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Chills (N=0,300) | NA Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Change in eating habits (N=104,0) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Sleepiness (N=104,0) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Irritability (N=104,0) | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Vomiting (N=104,0) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Nausea (N=0,300) | NA Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Malaise (N=0,300) | NA Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Diarrhoea (N=104,0) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Headache | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Rash | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Arthralgia | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Myalgia (N=0,300) | NA Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Fever (≥38°C) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Medic. used for pain | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Medic. used to prevent high temp. | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Medic. used to treat high temp | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Medically-attended fever | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Malaise (N=0,300) | 4 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Pain | 17 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Medic. used to prevent high temp. | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Erythema | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Diarrhoea (N=104,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Induration | 3 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Fever (≥38°C) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Swelling | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Headache | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Chills (N=0,300) | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Medically-attended fever | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Change in eating habits (N=104,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Rash | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Sleepiness (N=104,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Medic. used for pain | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Irritability (N=104,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Arthralgia | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Vomiting (N=104,0) | NA Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Medic. used to treat high temp | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Nausea (N=0,300) | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 | Myalgia (N=0,300) | 5 Number of subjects |
Secondary
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ
Safety was assessed in terms of number of subjects who reported immediate reactions within 30 minutes following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.
Time frame: Within 30 minutes after any vaccination
Population: Solicited safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Change in eating habits | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Erythema | 19 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Induration | 4 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Swelling | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Tenderness | 13 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Sleepiness | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Unusual crying | 4 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Vomiting | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Diarrhea | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Irritability | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Rash | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Fever (≥38°C) | 3 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used for pain (N=252,248,250) | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medically-attended fever | 0 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used to treat high temp. (N=252,248,250) | 1 Number of subjects |
| B_3h5_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used to prevent high temp. (N=252,248,250) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Sleepiness | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Unusual crying | 3 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Vomiting | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medically-attended fever | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Diarrhea | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Irritability | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used to prevent high temp. (N=252,248,250) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Rash | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Tenderness | 9 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used to treat high temp. (N=252,248,250) | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Erythema | 19 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Fever (≥38°C) | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Induration | 3 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Swelling | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Change in eating habits | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used for pain (N=252,248,250) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Rash | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Sleepiness | 3 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used for pain (N=252,248,250) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Induration | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Unusual crying | 4 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used to prevent high temp. (N=252,248,250) | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Tenderness | 9 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Vomiting | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Fever (≥38°C) | 2 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Change in eating habits | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Diarrhea | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medically-attended fever | 0 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Erythema | 7 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Irritability | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Swelling | 1 Number of subjects |
| B_68_11 | Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ | Medic. used to treat high temp. (N=252,248,250) | 0 Number of subjects |
Secondary
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or as a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.
Time frame: Day 1 to day 7 after any vaccination
Population: Solicited safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Swelling (N=245,241,244) | 120 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Tenderness (N=245,241,244) | 200 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Erythema (N=245,241,244) | 164 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Induration (N=245,241,244) | 161 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Any local (N=245,241,244) | 226 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Any systemic (N=245,241,244) | 238 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Change in eating habits (N=245,241,244) | 141 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Sleepiness (N=245,241,244) | 186 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Irritability (N=245,241,244) | 180 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Vomiting (N=245,241,244) | 65 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Diarrhea (N=245,241,244) | 91 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Rash (N=245,241,244) | 23 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Unusual Crying (N=245,241,244) | 198 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Fever (≥38°C) (N=245,241,244) | 197 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used for pain (N=245,241,244) | 129 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used to prevent high temp. (N=245,241,244) | 97 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used to treat high temp. (N=245,242,244) | 193 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medically-attended fever | 16 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medically-attended fever | 10 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Any local (N=245,241,244) | 213 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Vomiting (N=245,241,244) | 39 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Unusual Crying (N=245,241,244) | 186 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Tenderness (N=245,241,244) | 174 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used for pain (N=245,241,244) | 110 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used to prevent high temp. (N=245,241,244) | 94 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Erythema (N=245,241,244) | 156 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Diarrhea (N=245,241,244) | 69 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used to treat high temp. (N=245,242,244) | 186 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Induration (N=245,241,244) | 117 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Irritability (N=245,241,244) | 156 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Fever (≥38°C) (N=245,241,244) | 189 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Swelling (N=245,241,244) | 75 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Sleepiness (N=245,241,244) | 152 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Rash (N=245,241,244) | 21 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Any systemic (N=245,241,244) | 236 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Change in eating habits (N=245,241,244) | 112 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Any systemic (N=245,241,244) | 233 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Change in eating habits (N=245,241,244) | 121 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Sleepiness (N=245,241,244) | 143 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used for pain (N=245,241,244) | 109 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Irritability (N=245,241,244) | 151 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medically-attended fever | 15 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Vomiting (N=245,241,244) | 55 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Diarrhea (N=245,241,244) | 74 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used to prevent high temp. (N=245,241,244) | 99 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Rash (N=245,241,244) | 22 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Any local (N=245,241,244) | 202 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Tenderness (N=245,241,244) | 166 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Unusual Crying (N=245,241,244) | 156 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Erythema (N=245,241,244) | 157 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Induration (N=245,241,244) | 121 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Swelling (N=245,241,244) | 84 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Fever (≥38°C) (N=245,241,244) | 184 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ | Medic. used to treat high temp. (N=245,242,244) | 177 Number of subjects |
Secondary
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2- 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.
Time frame: Day 1 to day 7 after any vaccination
Population: Solicited safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Any Local (N=100,297) | 99 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Pain (N=100,297) | 98 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Erythema (N=100,297) | 58 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Induration (N=100,297) | 41 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Swelling (N=100,297) | 50 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Any systemic (N=100,297) | 78 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Chills (N=0,296) | NA Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Change in eating habits (N=100,0) | 35 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Sleepiness (N=100,0) | 39 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Irritability (N=100,0) | 49 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Malaise (N=0,296) | NA Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Vomiting (N=100,0) | 7 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Nausea (N=0,296) | NA Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Diarrhea (N=100,0) | 12 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Headache (N=100,296) | 7 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Rash (N=100,296) | 9 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Arthralgia (N=100,296) | 35 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Myalgia (N=0,296) | NA Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Fever (≥38°C) (N=100,296) | 20 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Medic. used for pain (N=100,296) | 48 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Medic. used to prevent high temp. (N=100,296) | 7 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Medic. used to treat high temp. (N=100,296) | 20 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Medically-attended fever | 0 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Vomiting (N=100,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Any Local (N=100,297) | 287 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Myalgia (N=0,296) | 126 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Pain (N=100,297) | 287 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Nausea (N=0,296) | 36 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Erythema (N=100,297) | 179 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Medic. used to prevent high temp. (N=100,296) | 44 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Induration (N=100,297) | 123 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Diarrhea (N=100,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Swelling (N=100,297) | 146 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Fever (≥38°C) (N=100,296) | 41 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Any systemic (N=100,297) | 205 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Headache (N=100,296) | 89 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Chills (N=0,296) | 45 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Medically-attended fever | 7 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Change in eating habits (N=100,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Rash (N=100,296) | 20 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Sleepiness (N=100,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Medic. used for pain (N=100,296) | 158 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Irritability (N=100,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Arthralgia (N=100,296) | 49 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Malaise (N=0,296) | 114 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 | Medic. used to treat high temp. (N=100,296) | 54 Number of subjects |
Secondary
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.
Time frame: Day 1 to day 7 after any vaccination
Population: Solicited safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Any local rMenB + OMZ NV | 107 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Any local MenC-CRM | 104 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Any systemic | 123 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Tenderness (rMenB+OMV NZ) (N=123,0) | 105 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Erythema (rMenB+OMV NZ) (N=123,0) | 48 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Induration (rMenB+OMV NZ) (N=123,0) | 37 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Swelling (rMenB+OMV NZ) (N=123,0) | 21 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Tenderness (MenC-CRM) (N=123,117) | 104 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Erythema (MenC-CRM) (N=123,117) | 25 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Induration (MenC-CRM) (N=123,117) | 10 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Swelling (MenC-CRM) (N=123,117) | 12 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Change in eating habits (N=123,117) | 67 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Sleepiness (N=123,117) | 93 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Unusual crying (N=123,117) | 105 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Irritability (N=123,117) | 95 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Vomiting (N=123,117) | 29 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Diarrhea (N=123,117) | 41 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Rash (N=123,117) | 8 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Fever (≥38°C) (N=123,117) | 97 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used for pain (N=123,117) | 102 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used to prevent high temp. | 49 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used to treat high temp. | 90 Number of subjects |
| B_3h5_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medically-attended fever | 7 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Change in eating habits (N=123,117) | 47 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Any local rMenB + OMZ NV | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Rash (N=123,117) | 4 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Any local MenC-CRM | 79 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Sleepiness (N=123,117) | 78 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Any systemic | 106 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used to prevent high temp. | 25 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Tenderness (rMenB+OMV NZ) (N=123,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Unusual crying (N=123,117) | 87 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Erythema (rMenB+OMV NZ) (N=123,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Fever (≥38°C) (N=123,117) | 45 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Induration (rMenB+OMV NZ) (N=123,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Irritability (N=123,117) | 66 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Swelling (rMenB+OMV NZ) (N=123,0) | NA Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medically-attended fever | 12 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Tenderness (MenC-CRM) (N=123,117) | 74 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Vomiting (N=123,117) | 27 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Erythema (MenC-CRM) (N=123,117) | 24 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used for pain (N=123,117) | 69 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Induration (MenC-CRM) (N=123,117) | 26 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Diarrhea (N=123,117) | 40 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Swelling (MenC-CRM) (N=123,117) | 21 Number of subjects |
| B_68_11 | Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination | Medic. used to treat high temp. | 40 Number of subjects |
Secondary
Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination
Immunogenicity was assessed in terms of percentages of subjects achieving 4-fold increase in hSBA titers as compared to baseline against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS- primary series.
Time frame: 1 month after second vaccination
Population: FAS- primary series
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | H44/76 (1 month after 2nd vacc; N=385) | 96 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | 5/99 (1 month after 2nd vacc) | 99 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | NZ98/254 (1 month after 2nd vacc; N=387) | 93 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | M10713 (1 month after 2nd vacc; N=352) | 46 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713, following 3-dose primary series of vaccination with rMenB+OMV NZ at 2.5, 3.5 and 5 months of age. Analysis was done on FAS-primary series.
Time frame: 1 month after third vaccination
Population: FAS-primary series
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | H44/76 (hSBA≥ 4; 1 month after 3rd vacc; N=237) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | 5/99 (hSBA≥ 4; 1 month after 3rd vacc) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 4; 1 month after 3rd vacc) | 99 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | M10713 (hSBA≥ 5; 1 month after 3rd vacc; N=197) | 55 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | H44/76 (hSBA≥ 8; 1 month after 3rd vacc; N=237) | 98 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | 5/99 (hSBA≥ 8; 1 month after 3rd vacc) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 8; 1 month after 3rd vacc) | 89 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination | M10713 (hSBA≥ 8; 1 month after 3rd vacc; N=197) | 47 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 after the first infant vaccination in groups B\_2h3h5\_11b, B\_3h5\_11b and B\_68\_11b (at 3.5, 5, and 8 months of age respectively). Analysis was done on FAS-post first dose.
Time frame: Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination)
Population: FAS-post first dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | H44/76 (hSBA≥ 4; Post 1st vacc; N=117,115,117) | 62 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | 5/99 (hSBA≥ 4; Post 1st vacc) | 91 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | NZ98/254 (hSBA≥ 4; Post 1st vacc; N=118,114,117) | 43 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | M10713 (hSBA≥ 5; Post1st vacc; N=95,99,95) | 31 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | H44/76 (hSBA≥ 8; Post 1st vacc; N=117,115,117) | 25 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | 5/99 (hSBA≥ 8; Post1st vacc) | 82 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | NZ98/254 (hSBA≥ 8; 1st vacc; N=118,114,117) | 13 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | M10713 (hSBA≥ 8; Post1st vacc; N=95,99,95) | 21 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | NZ98/254 (hSBA≥ 4; Post 1st vacc; N=118,114,117) | 39 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | NZ98/254 (hSBA≥ 8; 1st vacc; N=118,114,117) | 7 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | M10713 (hSBA≥ 5; Post1st vacc; N=95,99,95) | 18 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | H44/76 (hSBA≥ 8; Post 1st vacc; N=117,115,117) | 38 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | 5/99 (hSBA≥ 8; Post1st vacc) | 90 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | H44/76 (hSBA≥ 4; Post 1st vacc; N=117,115,117) | 72 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | 5/99 (hSBA≥ 4; Post 1st vacc) | 95 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | M10713 (hSBA≥ 8; Post1st vacc; N=95,99,95) | 15 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | NZ98/254 (hSBA≥ 4; Post 1st vacc; N=118,114,117) | 41 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | 5/99 (hSBA≥ 4; Post 1st vacc) | 92 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | H44/76 (hSBA≥ 4; Post 1st vacc; N=117,115,117) | 82 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | M10713 (hSBA≥ 5; Post1st vacc; N=95,99,95) | 17 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | NZ98/254 (hSBA≥ 8; 1st vacc; N=118,114,117) | 13 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | 5/99 (hSBA≥ 8; Post1st vacc) | 86 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | H44/76 (hSBA≥ 8; Post 1st vacc; N=117,115,117) | 58 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV | M10713 (hSBA≥ 8; Post1st vacc; N=95,99,95) | 13 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following a booster dose of rMenB+OMV NZ given at 11 months of age (4th dose for B\_2h3h5\_11 and 3rd dose for B\_3h5\_11 and B\_68\_11). Analysis was done on FAS-booster.
Time frame: 1 month post-booster dose
Population: FAS-booster
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | H44/76 (hSBA≥ 4, after booster; N=233,227,238) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | 5/99 (hSBA≥ 4, after booster) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 4, after booster; N=231,226,236) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | M10713 (hSBA≥ 5, after booster; N=203,181,193) | 83 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | H44/76 (hSBA≥ 8, after booster; N=233,227,238) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | 5/99 (hSBA≥ 8, after booster) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 8, after booster; N=231,226,236) | 95 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | M10713 (hSBA≥ 8, after booster; N=203,181,193) | 78 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 4, after booster; N=231,226,236) | 99 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 8, after booster; N=231,226,236) | 95 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | M10713 (hSBA≥ 5, after booster; N=203,181,193) | 87 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | H44/76 (hSBA≥ 8, after booster; N=233,227,238) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | 5/99 (hSBA≥ 8, after booster) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | H44/76 (hSBA≥ 4, after booster; N=233,227,238) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | 5/99 (hSBA≥ 4, after booster) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | M10713 (hSBA≥ 8, after booster; N=203,181,193) | 83 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 4, after booster; N=231,226,236) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | 5/99 (hSBA≥ 4, after booster) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | H44/76 (hSBA≥ 4, after booster; N=233,227,238) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | M10713 (hSBA≥ 5, after booster; N=203,181,193) | 83 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 8, after booster; N=231,226,236) | 97 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | 5/99 (hSBA≥ 8, after booster) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | H44/76 (hSBA≥ 8, after booster; N=233,227,238) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination | M10713 (hSBA≥ 8, after booster; N=203,181,193) | 74 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and a booster at 12 months. Analysis was done on FAS-primary series and FAS-booster.
Time frame: 1 month after second vaccination and 1 month after booster vaccination
Population: FAS-primary series and FAS-booster
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | H44/76 (hSBA≥4; 1 month after 2nd vacc) | 97 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | H44/76 (hSBA≥4; 1 month after booster vacc; N=114) | 100 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 5/99 (hSBA≥4; 1 month after 2nd vacc) | 96 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 5/99 (hSBA≥4; 1 month after booster vacc; N=113) | 97 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | NZ98/254 (hSBA≥4; 1 month after 2nd vacc; N=118) | 95 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | NZ98/254 (hSBA≥4; 1 mo after booster vacc; N=114) | 97 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | M10713 (hSBA≥5; 1 month after 2nd vacc; N=98) | 68 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | M10713 (hSBA≥5; 1 month after booster vacc; N=101) | 67 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | H44/76 (hSBA≥8; 1 month after 2nd vacc) | 97 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | H44/76 (hSBA≥8; 1 month after booster vacc; N=114) | 99 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 5/99 (hSBA≥8; 1 month after 2nd vacc) | 96 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | 5/99 (hSBA≥8; 1 month after booster vacc; N=113) | 97 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | NZ98/254 (hSBA≥8; 1 month after 2nd vacc; N=118) | 87 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | NZ98/254 (hSBA≥8; 1 mo after booster vacc; N=114) | 95 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | M10713 (hSBA≥8; 1 month after 2nd vacc; N=98) | 60 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM | M10713 (hSBA≥8; 1 month after booster vacc; N=101) | 61 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS-primary series.
Time frame: 1 month after second vaccination
Population: FAS-primary series
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | H44/76 (hSBA≥ 4; 1 month after 2nd vacc; N=386) | 99 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | 5/99 (hSBA≥ 4; 1 month after 2nd vacc) | 99 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 4; 1 month after 2nd vacc; N=389) | 99 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | M10713 (hSBA≥ 5; 1 month after 2nd vacc; N=370) | 94 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | H44/76 (hSBA≥ 8; 1 month after 2nd vacc; N=386) | 98 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | 5/99 (hSBA≥ 8; 1 month after 2nd vacc) | 99 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | NZ98/254 (hSBA≥ 8; 1 month after 2nd vacc; N=389) | 95 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination | M10713 (hSBA≥ 8; 1 month after 2nd vacc; N=370) | 92 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone
Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months, as measured by the percentages of subjects achieving hSBA titers ≥ 8 against serogroup C. Analysis was done on PPS-primary series and PPS-booster.
Time frame: Baseline, 1 month after second vaccination and 1 month after booster vaccination
Population: PPS-primary series and PPS-booster.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | Serogroup C (1 month after 2nd vacc) | 99 Percentages of subjects |
| B_3h5_11 | Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | Serogroup C (1 month after booster vacc; N=70,47) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | Serogroup C (1 month after 2nd vacc) | 100 Percentages of subjects |
| B_68_11 | Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone | Serogroup C (1 month after booster vacc; N=70,47) | 100 Percentages of subjects |
Comparison: Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after 2nd vaccination for serogroup C.95% CI: [-6.4, 3.9]Miettinen and Nurminen method
Comparison: Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after booster vaccination for serogroup C.95% CI: [-5.2, 7.6]Miettinen and Nurminen method