A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
Official Title
A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Mar 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2011
Primary Completion Date
Jan 2014Actual
Completion Date
Dec 2014Actual
First Submitted Date
Apr 13, 2011
First Submission Date that Met QC Criteria
Apr 20, 2011
First Posted Date
Apr 21, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 14, 2015
Results First Submitted that Met QC Criteria
Dec 14, 2015
Results First Posted Date
Jan 20, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 3, 2015
Certification/Extension First Submitted that Passed QC Review
Feb 3, 2015
Certification/Extension First Posted Date
Feb 23, 2015Estimated
Last Update Submitted Date
Mar 30, 2016
Last Update Posted Date
May 9, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Meningococcal Disease
Meningococcal Meningitis
Keywords
Meningococcal disease
Vaccines
intercalated administration
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,409Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
B_2h3h5_11
Experimental
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.
Biological: rMenB + OMV NZ vaccine
B_3h5_11
Experimental
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.
Biological: rMenB + OMV NZ vaccine
B_68_11
Experimental
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.
Biological: rMenB + OMV NZ vaccine
B_02_2_5
Experimental
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.
Biological: rMenB + OMV NZ vaccine
B_02_6_10
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
rMenB + OMV NZ vaccine
Biological
3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
B_2h3h5_11
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
1 month after second vaccination
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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).
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;
Available for all the visits scheduled in the study;
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria:
Individuals whose parent(s)/legal guardian(s) are unwilling or unable to give written informed consent to participate in the study;
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.
History of any meningococcal B vaccine administration;
Previous ascertained or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
Significant acute or chronic infection within the previous 7 days or temperature 38° C within the previous day of receiving the study vaccine;
Antibiotics treatment within 6 days prior to enrollment;
Individuals with history of allergy to vaccine components.
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);
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);
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.
Receipt of, or intent to immunize with, any other vaccine(s) within 7 days prior to enrollment.
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.
Family members and household members of research staff
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.
History of any meningococcal C vaccine administration (Only applicable to group V and VI).
History of any Pneumococcal vaccine administration (Only applicable to group V and VI).
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
71 Days
Maximum Age
10 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Vaccines
Novartis Vaccines
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Site 55 - Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Safadi MAP, Martinon-Torres F, Weckx LY, Moreira ED Junior, da Fonseca Lima EJ, Willemsen A, Toneatto D, Habib MA, Borys D. Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: A post-hoc analysis in a phase 3b, randomised, controlled trial. Vaccine. 2019 Aug 14;37(35):4858-4863. doi: 10.1016/j.vaccine.2019.07.021. Epub 2019 Jul 18.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
B_3h5_11
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: rMenB + OMV NZ vaccine
BC_35_12
Experimental
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.
Biological: Meningococcal C oligosaccharide conjugated vaccine
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.
Biological: Meningococcal C oligosaccharide conjugated vaccine
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.
1 month after second vaccination
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.
1 month after second vaccination
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.
1 month after primary series vaccination
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.
1, 1.5 or 2 months after first infant vaccination
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.
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)
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.
1 month post-booster dose
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.
11 months of age (persistence)
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.
11 months of age (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
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.
1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination
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.
1 month after second vaccination
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.
Baseline, 1 month after second vaccination and 1 month after booster vaccination
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.
1 month after second vaccination, 1 month after booster vaccination
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.
Pre-booster vaccination (persistence; 12 months of age)
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.
1 month after second vaccination and 1 month after booster vaccination
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.
1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
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.
1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
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.
Pre-booster vaccination (persistence; 12 months of age)
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.
Within 30 minutes after any vaccination
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.
Day 1 to day 7 after any vaccination
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.
Within 30 minutes after any vaccination
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.
Day 1 to day 7 after any vaccination
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.
Within 30 minutes after any vaccination
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.
Day 1 to day 7 after any vaccination
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.
Until 12 months of age; Day 1 to day 7 (All AEs)
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.
Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)
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.
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)
Site 54- Associação Obras Sociais Irmã Dulce, Avenida Bonfim, nº 161
Largo de Roma
Salvador/BA-CEP
40420-000
Brazil
Site 53 - CRIE UNIFESP
Rua Borges Lagoa 770
São Paulo
04038002
Brazil
Site 50 - Associacao Fundo de Incentivo a Psicofarmacologia
Rua Marselhesa 500 Vila Clementino
São Paulo
04020-060
Brazil
Site 37 - Praxis Dr Julianna Kovacs
Honved Utca 2
Bordany
6795
Hungary
Site 40 - General Pediatric Practice Hacsek
Poth Iren U 80
Budapest
Hungary
Site 42 - Praxis Dr Eszter Bari
Szentharomsag Ter 10
Csongrád megye
6640
Hungary
Site 34 - General Pediatric Practice Somorjai
Bajcsi Ut 32
Debrecen
4025
Hungary
Site 32 - Praxis Dr Eleonora Konya
Fo Utca 12
Malyi
3434
Hungary
Site 31 - General Practice Dr Olga Fekete
Kando Kalman Utca 1
Miskolc
3534
Hungary
Site 30 - General Practice Dr Simko
Selyemret U. 1.
Miskolc
3527
Hungary
Site 33 - General Pediatric Practice Ujhelyi
Szent Istvan U 10
Nyiregyhaza
4400
Hungary
Site 35 - Praxis Dr Eva Kovacs
Csongradi Sgt 63
Szeged
6723
Hungary
Site 36 - General Practice Dr Edit Oszlacs
Debreceni Utca 10-14
Szeged
6723
Hungary
Site 80 - Hospital Nacional docente Madre Nino San Bartolome
Av Alfonso Ugarte
Lima
Peru
Site 82 - Investigaciones Medicas en Salud INMENSA
Jr Jose de La Torre Ugarte Lince
Lima
Peru
Site 81 - Via Libre
Jr Paraguay Cercado de Lima
Lima
Peru
Site 15
AlmerÃa
04007
Spain
Site 16
AlmerÃa
04120
Spain
Site 20
Barcelona
08195
Spain
Site 17
Madrid
28041
Spain
Site 18
Madrid
28935
Spain
Site 11
Ourense
32005
Spain
Site 13
Pontevedra
36002
Spain
Site 10
Santiago de Compostela
15706
Spain
Site 14
Seville
41014
Spain
Derived
Martinon-Torres F, Carmona Martinez A, Simko R, Infante Marquez P, Arimany JL, Gimenez-Sanchez F, Couceiro Gianzo JA, Kovacs E, Rojo P, Wang H, Bhusal C, Toneatto D. Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018 Mar;76(3):258-269. doi: 10.1016/j.jinf.2017.12.005. Epub 2017 Dec 15.
P Safadi MA, Martinon-Torres F, Weckx LY, Moreira ED Junior, da Fonseca Lima EJ, Mensi I, Calabresi M, Toneatto D. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. Vaccine. 2017 Apr 11;35(16):2052-2059. doi: 10.1016/j.vaccine.2017.03.002. Epub 2017 Mar 18.
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
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.
FG000253 subjects
FG001250 subjects
FG002251 subjects
FG003104 subjects
FG004300 subjects
FG005126 subjects
FG006125 subjects
COMPLETED
FG000239 subjects
FG001234 subjects
FG002243 subjects
FG003100 subjects
FG004295 subjects
FG005117 subjects
FG006111 subjects
NOT COMPLETED
FG00014 subjects
FG00116 subjects
FG0028 subjects
FG0034 subjects
FG0045 subjects
FG0059 subjects
FG00614 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Inappropriate Enrollment
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0014 subjects
FG0020 subjects
FG0033 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Unable to Classify
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0007 subjects
FG00111 subjects
FG0026 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
TOTAL
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000253
BG001250
BG002251
BG003104
BG004300
BG005126
BG006125
BG0071409
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
month
Title
Denominators
Categories
Title
Measurements
BG0002.0± 0.1
BG0013.0± 0.1
BG0026.0± 0.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000117
BG001124
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
FAS-Primary series
Posted
Number
97.5% Confidence Interval
Percentages of subjects
1 month after second vaccination
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Participants
OG000230
OG001238
Title
Denominators
Categories
H44/76 (hSBA≥ 4; N=228, 234))
Title
Measurements
OG000100(97 to 100)
OG001100(97 to 100)
5/99 (hSBA≥ 4)
Title
Measurements
OG000
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.
FAS-primary series
Posted
Number
95% Confidence Interval
Percentages of subjects
1 month after third vaccination
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months of age) plus booster (11 months of age)
Units
Counts
Participants
OG000
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.
FAS-primary series
Posted
Number
95% Confidence Interval
Percentages of subjects
1 month after second vaccination
ID
Title
Description
OG000
B_02
Subjects, 2-10 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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
Units
Counts
Participants
OG000
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.
FAS- primary series
Posted
Number
95% Confidence Interval
Percentages of subjects
1 month after second vaccination
ID
Title
Description
OG000
B_02
Subjects, 2-10 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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
Units
Counts
Participants
OG000
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.
FAS-primary series
Posted
Geometric Mean
95% Confidence Interval
Titers
1 month after primary series vaccination
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
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.
rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)
OG002
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.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
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.
FAS-post first dose
Posted
Geometric Mean
95% Confidence Interval
Titers
1, 1.5 or 2 months after first infant vaccination
ID
Title
Description
OG000
B_2h3h5_11b
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. Blood draw at 3.5, 6, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
B_3h5_11b
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. Blood draw at 5, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)
OG002
B_68_11b
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.
FAS-post first dose
Posted
Number
95% Confidence Interval
Percentages of subjects
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)
ID
Title
Description
OG000
B_2h3h5_11b
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. Blood draw at 3.5, 6, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
B_3h5_11b
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. Blood draw at 5, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)
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.
FAS-booster
Posted
Number
95% Confidence Interval
Percentages of subjects
1 month post-booster dose
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
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.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)
OG002
B_68_11
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.
FAS-persistence
Posted
Number
95% Confidence Interval
Percentages of subjects
11 months of age (persistence)
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
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.
rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)
OG002
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.
FAS-persistence
Posted
Geometric Mean
95% Confidence Interval
Titers
11 months of age (persistence)
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
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.
rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)
OG002
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.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
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.
FAS-persistence and FAS-booster
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
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.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)
OG002
B_68_11
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.
FAS-primary series
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after second vaccination
ID
Title
Description
OG000
B_02
Subjects, 2-10 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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
Units
Counts
Participants
OG000
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.
PPS-primary series and PPS-booster.
Posted
Number
95% Confidence Interval
Percentages of subjects
Baseline, 1 month after second vaccination and 1 month after booster vaccination
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
FAS-primary series and FAS-booster
Posted
Geometric Mean
95% Confidence Interval
Titers
1 month after second vaccination, 1 month after booster vaccination
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
FAS-persistence
Posted
Geometric Mean
95% Confidence Interval
Titers
Pre-booster vaccination (persistence; 12 months of age)
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine
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 ad 15 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine
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.
FAS-primary series and FAS-booster
Posted
Number
95% Confidence Interval
Percentages of subjects
1 month after second vaccination and 1 month after booster vaccination
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
FAS-persistence and FAS-booster
Posted
Geometric Mean
95% Confidence Interval
Titers
1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
FAS-primary and FAS-booster
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
FAS-persistence
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Pre-booster vaccination (persistence; 12 months of age)
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
Solicited safety set.
Posted
Number
Number of subjects
Within 30 minutes after any vaccination
ID
Title
Description
OG000
B_2h3h5_11b
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. Blood draw at 3.5, 6, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
B_3h5_11b
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. Blood draw at 5, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)
OG002
B_68_11b
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. Blood draw at 8, 9, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
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.
Solicited safety set
Posted
Number
Number of subjects
Day 1 to day 7 after any vaccination
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
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.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)
OG002
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.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
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.
Solicited safety set
Posted
Number
Number of subjects
Within 30 minutes after any vaccination
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
OG001
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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
Units
Counts
Participants
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.
Solicited safety set
Posted
Number
Number of subjects
Day 1 to day 7 after any vaccination
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
OG001
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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
Units
Counts
Participants
OG000
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.
Solicited safety set
Posted
Number
Number of subjects
Within 30 minutes after any vaccination
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
Solicited safety set
Posted
Number
Number of subjects
Day 1 to day 7 after any vaccination
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
Unsolicited safety set
Posted
Number
Number of subjects
Until 12 months of age; Day 1 to day 7 (All AEs)
ID
Title
Description
OG000
B_2h3h5_11b
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. Blood draw at 3.5, 6, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
OG001
B_3h5_11b
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. Blood draw at 5, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)
OG002
B_68_11b
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.
Unsolicited safety set
Posted
Number
Number of subjects
Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)
ID
Title
Description
OG000
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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
OG001
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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
Units
Counts
Participants
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.
Unsolicited safety set
Posted
Number
Number of subjects
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)
ID
Title
Description
OG000
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
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.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12.
Description
All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
15
252
246
252
EG001
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.
18
249
240
249
EG002
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.
9
250
245
250
EG003
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.
1
104
100
104
EG004
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.
2
300
288
300
EG005
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.
5
126
124
126
EG006
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.
8
123
115
123
EG007
TOTAL
All subjects in the safety population.
58
1,404
1,358
1,404
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0012 affected249 at risk
EG0020 affected250 at risk
EG0030 affected104 at risk
EG0040 affected300 at risk
EG0050 affected126 at risk
EG0060 affected123 at risk
EG0072 affected1,404 at risk
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0021 affected250 at risk
EG003
CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY
Congenital, familial and genetic disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
GLAUCOMA
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
ALLERGIC COLITIS
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
FOOD POISONING
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
PYREXIA
General disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected252 at risk
EG0012 affected249 at risk
EG0021 affected250 at risk
EG003
ATYPICAL PNEUMONIA
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
BRONCHIOLITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0012 affected249 at risk
EG0023 affected250 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected252 at risk
EG0012 affected249 at risk
EG0021 affected250 at risk
EG003
BRONCHOPNEUMONIA
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0014 affected249 at risk
EG0022 affected250 at risk
EG003
GASTROENTERITIS ROTAVIRUS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
GASTROENTERITIS SALMONELLA
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected252 at risk
EG0010 affected249 at risk
EG0021 affected250 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
MASTOIDITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0012 affected249 at risk
EG0021 affected250 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0021 affected250 at risk
EG003
SALMONELLOSIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0021 affected250 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
CONCUSSION
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
SKULL FRACTURE
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
COW'S MILK INTOLERANCE
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0013 affected249 at risk
EG0020 affected250 at risk
EG003
JUVENILE IDIOPATHIC ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0021 affected250 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
BENIGN INTRACRANIAL HYPERTENSION
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
FEBRILE CONVULSION
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
GENERALISED TONIC-CLONIC SEIZURE
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
HYDRONEPHROSIS
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
ADENOIDAL HYPERTROPHY
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0022 affected250 at risk
EG003
CHOKING
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
SLEEP APNOEA SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
TONSILLAR HYPERTROPHY
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0011 affected249 at risk
EG0020 affected250 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
DIARRHOEA
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00096 affected252 at risk
EG00174 affected249 at risk
EG00276 affected250 at risk
EG00312 affected104 at risk
EG0045 affected300 at risk
EG00541 affected126 at risk
EG00649 affected123 at risk
EG007353 affected1,404 at risk
NAUSEA
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00069 affected252 at risk
EG00146 affected249 at risk
EG00258 affected250 at risk
EG003
CHILLS
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
CRYING
General disorders
MedDRA 18.0
Systematic Assessment
EG000198 affected252 at risk
EG001186 affected249 at risk
EG002157 affected250 at risk
EG003
INDURATION
General disorders
MedDRA 18.0
Systematic Assessment
EG00058 affected252 at risk
EG00123 affected249 at risk
EG00227 affected250 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
MedDRA 18.0
Systematic Assessment
EG000169 affected252 at risk
EG001160 affected249 at risk
EG002157 affected250 at risk
EG003
INJECTION SITE INDURATION
General disorders
MedDRA 18.0
Systematic Assessment
EG000162 affected252 at risk
EG001118 affected249 at risk
EG002122 affected250 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA 18.0
Systematic Assessment
EG000202 affected252 at risk
EG001175 affected249 at risk
EG002168 affected250 at risk
EG003
INJECTION SITE SWELLING
General disorders
MedDRA 18.0
Systematic Assessment
EG000120 affected252 at risk
EG00176 affected249 at risk
EG00284 affected250 at risk
EG003
MALAISE
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
PYREXIA
General disorders
MedDRA 18.0
Systematic Assessment
EG000201 affected252 at risk
EG001192 affected249 at risk
EG002189 affected250 at risk
EG003
SWELLING
General disorders
MedDRA 18.0
Systematic Assessment
EG00026 affected252 at risk
EG0016 affected249 at risk
EG00219 affected250 at risk
EG003
BRONCHIOLITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00018 affected252 at risk
EG00126 affected249 at risk
EG00213 affected250 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00037 affected252 at risk
EG00136 affected249 at risk
EG00233 affected250 at risk
EG003
BRONCHOPNEUMONIA
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0012 affected249 at risk
EG0021 affected250 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00027 affected252 at risk
EG00115 affected249 at risk
EG00217 affected250 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00012 affected252 at risk
EG0019 affected249 at risk
EG00216 affected250 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00025 affected252 at risk
EG00123 affected249 at risk
EG00232 affected250 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0007 affected252 at risk
EG0014 affected249 at risk
EG0025 affected250 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00012 affected252 at risk
EG0015 affected249 at risk
EG00215 affected250 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00038 affected252 at risk
EG00131 affected249 at risk
EG00247 affected250 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0007 affected252 at risk
EG0014 affected249 at risk
EG00214 affected250 at risk
EG003
OTITIS MEDIA ACUTE
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00010 affected252 at risk
EG0018 affected249 at risk
EG00214 affected250 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00011 affected252 at risk
EG00110 affected249 at risk
EG00214 affected250 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00018 affected252 at risk
EG00114 affected249 at risk
EG00228 affected250 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0006 affected252 at risk
EG0013 affected249 at risk
EG0027 affected250 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00049 affected252 at risk
EG00156 affected249 at risk
EG00254 affected250 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00016 affected252 at risk
EG00126 affected249 at risk
EG00214 affected250 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected252 at risk
EG0010 affected249 at risk
EG0020 affected250 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG000186 affected252 at risk
EG001152 affected249 at risk
EG002144 affected250 at risk
EG003
EATING DISORDER
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG000141 affected252 at risk
EG001112 affected249 at risk
EG002121 affected250 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG000181 affected252 at risk
EG001156 affected249 at risk
EG002153 affected250 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected252 at risk
EG0015 affected249 at risk
EG0023 affected250 at risk
EG003
CATARRH
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected252 at risk
EG00114 affected249 at risk
EG00214 affected250 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00012 affected252 at risk
EG0016 affected249 at risk
EG00213 affected250 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00020 affected252 at risk
EG0018 affected249 at risk
EG00212 affected250 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00036 affected252 at risk
EG00128 affected249 at risk
EG00232 affected250 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com
ID
Term
D008589
Meningococcal Infections
D008585
Meningitis, Meningococcal
Ancestor Terms
ID
Term
D016870
Neisseriaceae Infections
D016905
Gram-Negative Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
D016920
Meningitis, Bacterial
D020806
Central Nervous System Bacterial Infections
D002494
Central Nervous System Infections
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D008581
Meningitis
D000090862
Neuroinflammatory Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
1 subjects
FG0051 subjects
FG0065 subjects
0 subjects
FG0053 subjects
FG0061 subjects
0 subjects
FG0051 subjects
FG0065 subjects
4 subjects
FG0053 subjects
FG0062 subjects
47.5
± 13.4
BG00496.9± 16.8
BG0053.0± 0.2
BG0063.0± 0.1
BG00726.6± 39.3
127
BG00349
BG004149
BG00574
BG00659
BG007699
Male
BG000136
BG001126
BG002124
BG00355
BG004151
BG00552
BG00666
BG007710
100
(97 to 100)
OG001100(98 to 100)
NZ98/254 (hSBA≥ 4; N=230, 233)
Title
Measurements
OG00098(95 to 99)
OG00199(97 to 100)
M10713 (hSBA≥ 5; N=181, 192))
Title
Measurements
OG00044(35 to 52)
OG00173(65 to 80)
238
Title
Denominators
Categories
H44/76 (hSBA≥ 4; 1 month after 3rd vacc; N=237)
Title
Measurements
OG000100(98 to 100)
5/99 (hSBA≥ 4; 1 month after 3rd vacc)
Title
Measurements
OG000100(98 to 100)
NZ98/254 (hSBA≥ 4; 1 month after 3rd vacc)
Title
Measurements
OG00099(96 to 100)
M10713 (hSBA≥ 5; 1 month after 3rd vacc; N=197)
Title
Measurements
OG00055(48 to 62)
H44/76 (hSBA≥ 8; 1 month after 3rd vacc; N=237)
Title
Measurements
OG00098(96 to 100)
5/99 (hSBA≥ 8; 1 month after 3rd vacc)
Title
Measurements
OG000100(98 to 100)
NZ98/254 (hSBA≥ 8; 1 month after 3rd vacc)
Title
Measurements
OG00089(85 to 93)
M10713 (hSBA≥ 8; 1 month after 3rd vacc; N=197)
Title
Measurements
OG00047(40 to 54)
390
Title
Denominators
Categories
H44/76 (hSBA≥ 4; 1 month after 2nd vacc; N=386)
Title
Measurements
OG00099(97 to 100)
5/99 (hSBA≥ 4; 1 month after 2nd vacc)
Title
Measurements
OG00099(98 to 100)
NZ98/254 (hSBA≥ 4; 1 month after 2nd vacc; N=389)
Title
Measurements
OG00099(97 to 100)
M10713 (hSBA≥ 5; 1 month after 2nd vacc; N=370)
Title
Measurements
OG00094(91 to 96)
H44/76 (hSBA≥ 8; 1 month after 2nd vacc; N=386)
Title
Measurements
OG00098(96 to 99)
5/99 (hSBA≥ 8; 1 month after 2nd vacc)
Title
Measurements
OG00099(98 to 100)
NZ98/254 (hSBA≥ 8; 1 month after 2nd vacc; N=389)
Title
Measurements
OG00095(92 to 97)
M10713 (hSBA≥ 8; 1 month after 2nd vacc; N=370)
Title
Measurements
OG00092(89 to 94)
388
Title
Denominators
Categories
H44/76 (1 month after 2nd vacc; N=385)
Title
Measurements
OG00096(93 to 97)
5/99 (1 month after 2nd vacc)
Title
Measurements
OG00099(97 to 100)
NZ98/254 (1 month after 2nd vacc; N=387)
Title
Measurements
OG00093(89 to 95)
M10713 (1 month after 2nd vacc; N=352)
Title
Measurements
OG00046(41 to 51)
OG003
B_02
Subjects, 2-10 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.
rMenB + OMV NZ vaccine: 2 doses 2 months apart
Units
Counts
Participants
OG000238
OG001230
OG002238
OG003390
Title
Denominators
Categories
H44/76 (1 month after primary vacc; N=237,228,234,
Title
Measurements
OG000109(92 to 130)
OG001132(110 to 158)
OG002240(201 to 287)
OG003121(109 to 135)
5/99 (1 month after primary vacc)
Title
Measurements
OG000795(665 to 950)
OG001605(502 to 729)
OG0021157(964 to 1390)
OG003
NZ98/254 1m after primary vacc; N=238,230,233,389
Title
Measurements
OG00034(28 to 42)
OG00139(31 to 48)
OG00265(52 to 80)
OG003
M10713 1 m after primary vacc; N=197,181,192,370
Title
Measurements
OG0004.86(3.62 to 6.54)
OG0013.39(2.48 to 4.64)
OG0029.96(7.33 to 14)
OG003
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. Blood draw at 8, 9, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
Units
Counts
Participants
OG000119
OG001115
OG002118
Title
Denominators
Categories
H44/76 1 month after 1st vacc; N=117,115,117
Title
Measurements
OG0004.19(3.29 to 5.35)
OG0015.7(4.41 to 7.37)
OG0029.83(7.59 to 13)
5/99 1 month after 1st vacc
Title
Measurements
OG00020(15 to 27)
OG00130(22 to 42)
OG00237(27 to 52)
NZ98/254 1 month after 1st vacc; N=118,114,117
Title
Measurements
OG0002.87(2.32 to 3.54)
OG0012.48(1.98 to 3.11)
OG0022.84(2.28 to 3.55)
M10713 1 month after 1st vacc; N=95,99,95
Title
Measurements
OG0002.59(1.86 to 3.6)
OG0011.69(1.21 to 2.36)
OG0021.62(1.15 to 2.28)
OG002
B_68_11b
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. Blood draw at 8, 9, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
Units
Counts
Participants
OG000119
OG001115
OG002118
Title
Denominators
Categories
H44/76 (hSBA≥ 4; Post 1st vacc; N=117,115,117)
Title
Measurements
OG00062(52 to 70)
OG00172(63 to 80)
OG00282(74 to 89)
5/99 (hSBA≥ 4; Post 1st vacc)
Title
Measurements
OG00091(84 to 95)
OG00195(89 to 98)
OG00292(86 to 96)
NZ98/254 (hSBA≥ 4; Post 1st vacc; N=118,114,117)
Title
Measurements
OG00043(34 to 53)
OG00139(30 to 48)
OG00241(32 to 50)
M10713 (hSBA≥ 5; Post1st vacc; N=95,99,95)
Title
Measurements
OG00031(21 to 41)
OG00118(11 to 27)
OG00217(10 to 26)
H44/76 (hSBA≥ 8; Post 1st vacc; N=117,115,117)
Title
Measurements
OG00025(17 to 34)
OG00138(29 to 48)
OG00258(49 to 67)
5/99 (hSBA≥ 8; Post1st vacc)
Title
Measurements
OG00082(73 to 88)
OG00190(82 to 94)
OG00286(79 to 92)
NZ98/254 (hSBA≥ 8; 1st vacc; N=118,114,117)
Title
Measurements
OG00013(7 to 20)
OG0017(3 to 13)
OG00213(7 to 20)
M10713 (hSBA≥ 8; Post1st vacc; N=95,99,95)
Title
Measurements
OG00021(13 to 31)
OG00115(9 to 24)
OG00213(7 to 21)
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.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
Units
Counts
Participants
OG000233
OG001228
OG002239
Title
Denominators
Categories
H44/76 (hSBA≥ 4, after booster; N=233,227,238)
Title
Measurements
OG000100(98 to 100)
OG001100(98 to 100)
OG002100(98 to 100)
5/99 (hSBA≥ 4, after booster)
Title
Measurements
OG000100(98 to 100)
OG001100(98 to 100)
OG002100(98 to 100)
NZ98/254 (hSBA≥ 4, after booster; N=231,226,236)
Title
Measurements
OG000100(98 to 100)
OG00199(96 to 100)
OG002100(98 to 100)
M10713 (hSBA≥ 5, after booster; N=203,181,193)
Title
Measurements
OG00083(77 to 88)
OG00187(81 to 91)
OG00283(77 to 88)
H44/76 (hSBA≥ 8, after booster; N=233,227,238)
Title
Measurements
OG000100(98 to 100)
OG001100(98 to 100)
OG002100(98 to 100)
5/99 (hSBA≥ 8, after booster)
Title
Measurements
OG000100(98 to 100)
OG001100(98 to 100)
OG002100(98 to 100)
NZ98/254 (hSBA≥ 8, after booster; N=231,226,236)
Title
Measurements
OG00095(91 to 97)
OG00195(91 to 98)
OG00297(95 to 99)
M10713 (hSBA≥ 8, after booster; N=203,181,193)
Title
Measurements
OG00078(72 to 84)
OG00183(77 to 89)
OG00274(67 to 80)
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.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
Units
Counts
Participants
OG000235
OG001233
OG002238
Title
Denominators
Categories
H44/76 (hSBA≥ 4; 11 months of age; N=235,232,237)
Title
Measurements
OG00087(82 to 91)
OG00186(81 to 90)
OG002100(98 to 100)
5/99 (hSBA≥ 4; 11 months of age; N=234,230,235)
Title
Measurements
OG000100(98 to 100)
OG00193(89 to 96)
OG002100(98 to 100)
NZ98/254 hSBA≥ 4; 11 months of age; N=233,233,238)
Title
Measurements
OG00054(47 to 60)
OG00141(34 to 47)
OG00290(85 to 93)
M10713 (hSBA≥ 5; 11 months of age; N=199,177,188)
Title
Measurements
OG00033(26 to 40)
OG00123(17 to 30)
OG00242(35 to 49)
H44/76 (hSBA≥ 8; 11 months of age; N=235,232,237)
Title
Measurements
OG00064(58 to 70)
OG00160(53 to 66)
OG00296(93 to 98)
5/99 (hSBA≥ 8; 11 months of age; N=234,230,235)
Title
Measurements
OG00094(91 to 97)
OG00187(82 to 91)
OG00299(97 to 100)
NZ98/254 hSBA≥ 8; 11 months of age; N=233,233,238)
Title
Measurements
OG00036(30 to 43)
OG00112(8 to 17)
OG00265(58 to 71)
M10713 (hSBA≥ 8; 11 months of age; N=199,177,188)
Title
Measurements
OG00024(18 to 30)
OG00116(11 to 22)
OG00236(29 to 43)
Units
Counts
Participants
OG000235
OG001233
OG002238
Title
Denominators
Categories
H44/76 (Baseline; N=111,113,120)
Title
Measurements
OG0001.31(1.09 to 1.57)
OG0011.34(1.11 to 1.62)
OG0021.58(1.32 to 1.9)
H44/76 (11 moa; N=235,232,237))
Title
Measurements
OG00012(9.64 to 14)
OG00112(9.39 to 14)
OG00267(55 to 82)
5/99 (Baseline; N=113,112,120)
Title
Measurements
OG0001.15(1.02 to 1.3)
OG0011.16(1.02 to 1.32)
OG0020.97(0.85 to 1.09)
5/99 (11 moa; N=234,230,235)
Title
Measurements
OG00098(78 to 124)
OG00150(39 to 63)
OG002285(225 to 363)
NZ98/254 (Baseline; N=113,113,122)
Title
Measurements
OG0001.07(0.99 to 1.15)
OG0011.04(0.96 to 1.12)
OG0021(0.93 to 1.07)
NZ98/254 (11 moa; N=233,233,238)
Title
Measurements
OG0004.57(3.66 to 5.71)
OG0012.68(2.13 to 3.38)
OG00212(9.79 to 15)
M10713 (Baseline; N=84,64,88)
Title
Measurements
OG0002.36(1.75 to 3.2)
OG0011.52(1.07 to 2.17)
OG0021.29(0.95 to 1.76)
M10713 (11 moa; N=199,177,188)
Title
Measurements
OG0002.55(1.89 to 3.43)
OG0011.98(1.45 to 2.71)
OG0023.62(2.66 to 4.94)
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.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)
Units
Counts
Participants
OG000218
OG001225
OG002221
Title
Denominators
Categories
1 month after primary vaccination (N=212,215,212)
Title
Measurements
OG0004688(3884 to 5660)
OG0013152(2594 to 3831)
OG0024682(3850 to 5694)
Pre-booster vaccination (N=213,220,215)
Title
Measurements
OG000474(395 to 569)
OG001291(241 to 351)
OG0021270(1052 to 1533)
1 month after booster dose
Title
Measurements
OG0005900(5047 to 6898)
OG0016062(5150 to 7135)
OG0025898(5016 to 6934)
389
Title
Denominators
Categories
Title
Measurements
OG0002333(2124 to 2562)
Units
Counts
Participants
OG00085
OG00172
Title
Denominators
Categories
Serogroup C (1 month after 2nd vacc)
Title
Measurements
OG00099(94 to 100)
OG001100(95 to 100)
Serogroup C (1 month after booster vacc; N=70,47)
Title
Measurements
OG000100(95 to 100)
OG001100(92 to 100)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Miettinen and Nurminen method
Vaccine group difference
-1
2-Sided
95
-6.4
3.9
Yes
Non-Inferiority or Equivalence
Non-inferiority.
OG000
OG001
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.
Miettinen and Nurminen method
Vaccine group difference
0
2-Sided
95
-5.2
7.6
Yes
Non-Inferiority or Equivalence
Non-inferiority.
Units
Counts
Participants
OG000102
OG00188
Title
Denominators
Categories
1 month after 2nd vacc
Title
Measurements
OG000568(461 to 701)
OG001905(718 to 1141)
Pre-booster vacc (N=92,75)
Title
Measurements
OG00036(28 to 47)
OG00156(41 to 77)
1 month after booster vacc (N=99,92)
Title
Measurements
OG0001201(991 to 1456)
OG0011724(1350 to 2201)
Units
Counts
Participants
OG000108
OG00193
Title
Denominators
Categories
Title
Measurements
OG00036(28 to 46)
OG00156(41 to 75)
OG000119
Title
Denominators
Categories
H44/76 (hSBA≥4; 1 month after 2nd vacc)
Title
Measurements
OG00097(92 to 99)
H44/76 (hSBA≥4; 1 month after booster vacc; N=114)
Title
Measurements
OG000100(97 to 100)
5/99 (hSBA≥4; 1 month after 2nd vacc)
Title
Measurements
OG00096(90 to 99)
5/99 (hSBA≥4; 1 month after booster vacc; N=113)
Title
Measurements
OG00097(92 to 99)
NZ98/254 (hSBA≥4; 1 month after 2nd vacc; N=118)
Title
Measurements
OG00095(89 to 98)
NZ98/254 (hSBA≥4; 1 mo after booster vacc; N=114)
Title
Measurements
OG00097(93 to 99)
M10713 (hSBA≥5; 1 month after 2nd vacc; N=98)
Title
Measurements
OG00068(58 to 77)
M10713 (hSBA≥5; 1 month after booster vacc; N=101)
Title
Measurements
OG00067(57 to 76)
H44/76 (hSBA≥8; 1 month after 2nd vacc)
Title
Measurements
OG00097(92 to 99)
H44/76 (hSBA≥8; 1 month after booster vacc; N=114)
Title
Measurements
OG00099(95 to 100)
5/99 (hSBA≥8; 1 month after 2nd vacc)
Title
Measurements
OG00096(90 to 99)
5/99 (hSBA≥8; 1 month after booster vacc; N=113)
Title
Measurements
OG00097(92 to 99)
NZ98/254 (hSBA≥8; 1 month after 2nd vacc; N=118)
Title
Measurements
OG00087(80 to 93)
NZ98/254 (hSBA≥8; 1 mo after booster vacc; N=114)
Title
Measurements
OG00095(89 to 98)
M10713 (hSBA≥8; 1 month after 2nd vacc; N=98)
Title
Measurements
OG00060(50 to 70)
M10713 (hSBA≥8; 1 month after booster vacc; N=101)
Title
Measurements
OG00061(51 to 71)
115
Title
Denominators
Categories
H44/76 (1 month after 2nd vacc)
Title
Measurements
OG000226(179 to 284)
H44/76 (Pre-booster vacc)
Title
Measurements
OG00016(13 to 20)
H44/76 (1 month after booster vacc; N=114)
Title
Measurements
OG000239(198 to 288)
5/99 (1 month after 2nd vacc)
Title
Measurements
OG000555(409 to 753)
5/99 (Pre-booster vacc)
Title
Measurements
OG00055(42 to 72)
5/99 (1 month after booster vacc; N=113)
Title
Measurements
OG0001623(1210 to 2176)
NZ98/254 (1 month after 2nd vacc; N=114)
Title
Measurements
OG00027(21 to 34)
NZ98/254 (Pre-booster vacc; N=115)
Title
Measurements
OG0002.63(2.21 to 3.14)
NZ98/254 (1 month after booster vacc; N=114)
Title
Measurements
OG00068(54 to 86)
M10713 (1 month after 2nd vacc; N=89)
Title
Measurements
OG0009.81(7.06 to 14)
M10713 (Pre-booster vacc; N=110)
Title
Measurements
OG0002.2(1.72 to 2.82)
M10713 (1 month after booster vacc; N=101)
Title
Measurements
OG00011(7.72 to 15)
OG000
116
Title
Denominators
Categories
1 month after 2nd vacc
Title
Measurements
OG0002125(1595 to 2830)
Pre-booster vacc (N=111)
Title
Measurements
OG000194(164 to 230)
1 month after booster vacc (N=113)
Title
Measurements
OG0004281(3411 to 5372)
115
Title
Denominators
Categories
Title
Measurements
OG000196(166 to 231)
Units
Counts
Participants
OG000252
OG001249
OG002250
Title
Denominators
Categories
Tenderness
Title
Measurements
OG00013
OG0019
OG0029
Erythema
Title
Measurements
OG00019
OG00119
OG0027
Induration
Title
Measurements
OG0004
OG0013
OG0022
Swelling
Title
Measurements
OG0001
OG0012
OG0021
Change in eating habits
Title
Measurements
OG0000
OG0012
OG0021
Sleepiness
Title
Measurements
OG0001
OG0012
OG0023
Unusual crying
Title
Measurements
OG0004
OG0013
OG0024
Vomiting
Title
Measurements
OG0001
OG0010
OG0020
Diarrhea
Title
Measurements
OG0000
OG0010
OG0021
Irritability
Title
Measurements
OG0001
OG0012
OG0021
Rash
Title
Measurements
OG0000
OG0011
OG0021
Fever (≥38°C)
Title
Measurements
OG0003
OG0012
OG0022
Medic. used for pain (N=252,248,250)
Title
Measurements
OG0000
OG0010
OG0020
Medically-attended fever
Title
Measurements
OG0000
OG0010
OG0020
Medic. used to treat high temp. (N=252,248,250)
Title
Measurements
OG0001
OG0011
OG0020
Medic. used to prevent high temp. (N=252,248,250)
Title
Measurements
OG0000
OG0010
OG0020
Units
Counts
Participants
OG000247
OG001243
OG002246
Title
Denominators
Categories
Any local (N=245,241,244)
Title
Measurements
OG000226
OG001213
OG002202
Tenderness (N=245,241,244)
Title
Measurements
OG000200
OG001174
OG002166
Erythema (N=245,241,244)
Title
Measurements
OG000164
OG001156
OG002157
Induration (N=245,241,244)
Title
Measurements
OG000161
OG001117
OG002121
Swelling (N=245,241,244)
Title
Measurements
OG000120
OG00175
OG00284
Any systemic (N=245,241,244)
Title
Measurements
OG000238
OG001236
OG002233
Change in eating habits (N=245,241,244)
Title
Measurements
OG000141
OG001112
OG002121
Sleepiness (N=245,241,244)
Title
Measurements
OG000186
OG001152
OG002143
Irritability (N=245,241,244)
Title
Measurements
OG000180
OG001156
OG002151
Vomiting (N=245,241,244)
Title
Measurements
OG00065
OG00139
OG00255
Diarrhea (N=245,241,244)
Title
Measurements
OG00091
OG00169
OG00274
Rash (N=245,241,244)
Title
Measurements
OG00023
OG00121
OG00222
Unusual Crying (N=245,241,244)
Title
Measurements
OG000198
OG001186
OG002156
Fever (≥38°C) (N=245,241,244)
Title
Measurements
OG000197
OG001189
OG002184
Medic. used for pain (N=245,241,244)
Title
Measurements
OG000129
OG001110
OG002109
Medic. used to prevent high temp. (N=245,241,244)
Title
Measurements
OG00097
OG00194
OG00299
Medic. used to treat high temp. (N=245,242,244)
Title
Measurements
OG000193
OG001186
OG002177
Medically-attended fever
Title
Measurements
OG00016
OG00110
OG00215
OG000
104
OG001300
Title
Denominators
Categories
Pain
Title
Measurements
OG0006
OG00117
Erythema
Title
Measurements
OG0006
OG0012
Induration
Title
Measurements
OG0001
OG0013
Swelling
Title
Measurements
OG0002
OG0012
Chills (N=0,300)
Title
Measurements
OG000NASolicited AE not applicable for this age-group.
OG0012
Change in eating habits (N=104,0)
Title
Measurements
OG0000
OG001NASolicited AE not applicable for this age-group.
Sleepiness (N=104,0)
Title
Measurements
OG0000
OG001NASolicited AE not applicable for this age-group.
Irritability (N=104,0)
Title
Measurements
OG0001
OG001NASolicited AE not applicable for this age-group.
Vomiting (N=104,0)
Title
Measurements
OG0000
OG001NASolicited AE not applicable for this age-group.
Nausea (N=0,300)
Title
Measurements
OG000NASolicited AE not applicable for this age-group.
OG0012
Malaise (N=0,300)
Title
Measurements
OG000NASolicited AE not applicable for this age-group.
OG0014
Diarrhoea (N=104,0)
Title
Measurements
OG0000
OG001NASolicited AE not applicable for this age-group.
Headache
Title
Measurements
OG0000
OG0011
Rash
Title
Measurements
OG0000
OG0010
Arthralgia
Title
Measurements
OG0000
OG0011
Myalgia (N=0,300)
Title
Measurements
OG000NASolicited AE not applicable for this age-group.
OG0015
Fever (≥38°C)
Title
Measurements
OG0000
OG0010
Medic. used for pain
Title
Measurements
OG0000
OG0011
Medic. used to prevent high temp.
Title
Measurements
OG0000
OG0011
Medic. used to treat high temp
Title
Measurements
OG0000
OG0010
Medically-attended fever
Title
Measurements
OG0000
OG0010
102
OG001299
Title
Denominators
Categories
Any Local (N=100,297)
Title
Measurements
OG00099
OG001287
Pain (N=100,297)
Title
Measurements
OG00098
OG001287
Erythema (N=100,297)
Title
Measurements
OG00058
OG001179
Induration (N=100,297)
Title
Measurements
OG00041
OG001123
Swelling (N=100,297)
Title
Measurements
OG00050
OG001146
Any systemic (N=100,297)
Title
Measurements
OG00078
OG001205
Chills (N=0,296)
Title
Measurements
OG000NASolicited AE not applicable for this age-group.
OG00145
Change in eating habits (N=100,0)
Title
Measurements
OG00035
OG001NASolicited AE not applicable for this age-group.
Sleepiness (N=100,0)
Title
Measurements
OG00039
OG001NASolicited AE not applicable for this age-group.
Irritability (N=100,0)
Title
Measurements
OG00049
OG001NASolicited AE not applicable for this age-group.
Malaise (N=0,296)
Title
Measurements
OG000NASolicited AE not applicable for this age-group.
OG001114
Vomiting (N=100,0)
Title
Measurements
OG0007
OG001NASolicited AE not applicable for this age-group.
Nausea (N=0,296)
Title
Measurements
OG000NASolicited AE not applicable for this age-group.
OG00136
Diarrhea (N=100,0)
Title
Measurements
OG00012
OG001NASolicited AE not applicable for this age-group.
Headache (N=100,296)
Title
Measurements
OG0007
OG00189
Rash (N=100,296)
Title
Measurements
OG0009
OG00120
Arthralgia (N=100,296)
Title
Measurements
OG00035
OG00149
Myalgia (N=0,296)
Title
Measurements
OG000NASolicited AE not applicable for this age-group.
OG001126
Fever (≥38°C) (N=100,296)
Title
Measurements
OG00020
OG00141
Medic. used for pain (N=100,296)
Title
Measurements
OG00048
OG001158
Medic. used to prevent high temp. (N=100,296)
Title
Measurements
OG0007
OG00144
Medic. used to treat high temp. (N=100,296)
Title
Measurements
OG00020
OG00154
Medically-attended fever
Title
Measurements
OG0000
OG0017
Units
Counts
Participants
OG000126
OG001124
Title
Denominators
Categories
Tenderness (rMenB+OMV NZ) (N=126,0)
Title
Measurements
OG0007
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Erythema (rMenB+OMV NZ) (N=126,0)
Title
Measurements
OG0003
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Induration (rMenB+OMV NZ) (N=126,0)
Title
Measurements
OG0001
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Swelling (rMenB+OMV NZ) (N=126,0)
Title
Measurements
OG0000
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Tenderness (MenC-CRM)
Title
Measurements
OG0005
OG0015
Erythema (MenC-CRM)
Title
Measurements
OG0004
OG0015
Induration (MenC-CRM)
Title
Measurements
OG0000
OG0010
Swelling (MenC-CRM)
Title
Measurements
OG0000
OG0010
Change in eating habits
Title
Measurements
OG0000
OG0010
Sleepiness
Title
Measurements
OG0000
OG0010
Unusual crying
Title
Measurements
OG0000
OG0010
Irritability
Title
Measurements
OG0000
OG0010
Vomiting
Title
Measurements
OG0001
OG0010
Diarrhea
Title
Measurements
OG0000
OG0010
Rash
Title
Measurements
OG0000
OG0010
Fever (≥38°C)
Title
Measurements
OG0001
OG0010
Medic. used for pain
Title
Measurements
OG0000
OG0010
Medic. used to prevent high temp.
Title
Measurements
OG0000
OG0010
Medic. used to treat high temp.
Title
Measurements
OG0000
OG0010
Medically-attended fever
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG000124
OG001117
Title
Denominators
Categories
Any local rMenB + OMZ NV
Title
Measurements
OG000107
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Any local MenC-CRM
Title
Measurements
OG000104
OG00179
Any systemic
Title
Measurements
OG000123
OG001106
Tenderness (rMenB+OMV NZ) (N=123,0)
Title
Measurements
OG000105
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Erythema (rMenB+OMV NZ) (N=123,0)
Title
Measurements
OG00048
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Induration (rMenB+OMV NZ) (N=123,0)
Title
Measurements
OG00037
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Swelling (rMenB+OMV NZ) (N=123,0)
Title
Measurements
OG00021
OG001NASubjects in this group did not receive rMenB+OMV NZ vaccination.
Tenderness (MenC-CRM) (N=123,117)
Title
Measurements
OG000104
OG00174
Erythema (MenC-CRM) (N=123,117)
Title
Measurements
OG00025
OG00124
Induration (MenC-CRM) (N=123,117)
Title
Measurements
OG00010
OG00126
Swelling (MenC-CRM) (N=123,117)
Title
Measurements
OG00012
OG00121
Change in eating habits (N=123,117)
Title
Measurements
OG00067
OG00147
Sleepiness (N=123,117)
Title
Measurements
OG00093
OG00178
Unusual crying (N=123,117)
Title
Measurements
OG000105
OG00187
Irritability (N=123,117)
Title
Measurements
OG00095
OG00166
Vomiting (N=123,117)
Title
Measurements
OG00029
OG00127
Diarrhea (N=123,117)
Title
Measurements
OG00041
OG00140
Rash (N=123,117)
Title
Measurements
OG0008
OG0014
Fever (≥38°C) (N=123,117)
Title
Measurements
OG00097
OG00145
Medic. used for pain (N=123,117)
Title
Measurements
OG000102
OG00169
Medic. used to prevent high temp.
Title
Measurements
OG00049
OG00125
Medic. used to treat high temp.
Title
Measurements
OG00090
OG00140
Medically-attended fever
Title
Measurements
OG0007
OG00112
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. Blood draw at 8, 9, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)