Safety, Tolerability and Immunogenicity of Novartis Menin... | NCT00661713 | Trialant
NCT00661713
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Mar 20, 2019Actual
Enrollment
1,631Actual
Phase
Phase 2Phase 3
Conditions
Meningococcal Disease
Interventions
rMenB+OMV NZ
Placebo
Countries
Chile
Protocol Section
Identification Module
NCT ID
NCT00661713
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V72P10
Secondary IDs
Not provided
Brief Title
Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
Official Title
A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Mar 2019
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
Jun 2008
Primary Completion Date
Apr 2010Actual
Completion Date
Dec 2010Actual
First Submitted Date
Apr 16, 2008
First Submission Date that Met QC Criteria
Apr 16, 2008
First Posted Date
Apr 18, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 3, 2015
Results First Submitted that Met QC Criteria
Oct 7, 2015
Results First Posted Date
Nov 4, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 7, 2019
Last Update Posted Date
Mar 20, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.
Detailed Description
Not provided
Conditions Module
Conditions
Meningococcal Disease
Keywords
Meningococcal disease
Neisseria meningitidis serogroup B
prevention
vaccination
adolescents
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,631Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
rMenB06
Experimental
Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6).
Biological: rMenB+OMV NZ
Biological: Placebo
rMenB0
Experimental
Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
Biological: rMenB+OMV NZ
Biological: Placebo
rMenB016
Experimental
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
Biological: rMenB+OMV NZ
Biological: Placebo
rMenB01
Experimental
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6).
Biological: rMenB+OMV NZ
Biological: Placebo
rMenB026
Experimental
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
rMenB+OMV NZ
Biological
rMenB0
rMenB01
rMenB012
rMenB016
rMenB02
rMenB026
rMenB06
rMenB6
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Month-1, 2, 3
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV
1 to 7 days after each vaccination
Secondary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.
Month-6 & 7
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
1)11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
2)who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
3)in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria:
History of any meningococcal B vaccine administration;
Current or previous, confirmed or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
Antibiotics within 6 days prior to enrollment;
Pregnancy or nursing (breastfeeding) mothers;
Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; 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, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants;
Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed fluvaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw at Study Month 7);
Participation in another clinical trial within the last 90 days or planned for during study;
Family members and household members of research staff;
Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
11 Years
Maximum Age
17 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 13: Liceo Diego Aracena de Lo Barnechea
Monseñor Escrivá de Balaguer 14630, Lo Barnechea
Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.
Subjects were enrolled at 10 study centers in Chile.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
FG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
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
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
Biological: rMenB+OMV NZ
Biological: Placebo
rMenB02
Experimental
Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6).
Biological: rMenB+OMV NZ
Biological: Placebo
rMenB012
Experimental
Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6).
Biological: rMenB+OMV NZ
Biological: Placebo
rMenB6
Experimental
Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6).
Biological: rMenB+OMV NZ
Biological: Placebo
Serogroup B Meningococcal Vaccine
Placebo
Biological
rMenB0
rMenB01
rMenB012
rMenB016
rMenB02
rMenB026
rMenB06
rMenB6
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.
at baseline, month-1, month-2, month-3, month-6 and month-7.
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.
Month-1, month-2, month-3 and month-7
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
month-1, month-2, month-3, month-6 and month-7
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
month-1, month-2, month-3, month-6 and month-7
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.
month-1, month-2, month-3, month-6 and month-7
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen
month-1, month-2, month-3, month-6 and month-7
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Munoz A, Toneatto D, Grana G, Wang H, Clemens R, Dull PM; V72P10 Meningococcal B Adolescent Vaccine Study group. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012 Feb 18;379(9816):617-24. doi: 10.1016/S0140-6736(11)61713-3. Epub 2012 Jan 18.
FG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
FG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
FG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
FG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
FG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
FG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
FG000128 subjects
FG001247 subjects
FG002128 subjects
FG003247 subjects
FG004127 subjects
FG005253 subjects
FG006373 subjects
FG007128 subjects
COMPLETED
FG000112 subjects
FG001208 subjects
FG002111 subjects
FG003219 subjects
FG004107 subjects
FG005216 subjects
FG006309 subjects
FG007117 subjects
NOT COMPLETED
FG00016 subjects
FG00139 subjects
FG00217 subjects
FG00328 subjects
FG00420 subjects
FG00537 subjects
FG00664 subjects
FG00711 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Unable to Classify
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG00011 subjects
FG00125 subjects
FG00212 subjects
FG00321 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0017 subjects
FG0022 subjects
FG0032 subjects
FG004
Administrative Reason
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Inappropriate Enrollment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
BG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
BG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
BG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
BG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
BG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
BG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
BG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000128
BG001247
BG002128
BG003247
BG004127
BG005253
BG006373
BG007128
BG0081631
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
years
Title
Denominators
Categories
Title
Measurements
BG00013.8± 1.9
BG00113.8± 1.9
BG00213.9± 1.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00076
BG001147
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 hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Analysis was performed as per the protocol dataset
Posted
Number
95% Confidence Interval
percentage of Subjects
Month-1, 2, 3
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG000112
OG001223
OG002113
OG003
Title
Denominators
Categories
44/76-SL- Mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003
Primary
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV
Analysis was performed as per the safety dataset.
Posted
Number
participants
1 to 7 days after each vaccination
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
Secondary
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.
Analysis was performed as per the protocol dataset.
Posted
Number
95% Confidence Interval
percentage of Subjects
Month-6 & 7
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
Secondary
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.
Analysis was performed as per the protocol dataset.
Posted
Number
95% Confidence Interval
percentage of Subjects
at baseline, month-1, month-2, month-3, month-6 and month-7.
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
Secondary
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.
Analysis was performed as per the protocol dataset.
Posted
Number
95% Confidence Interval
percentage of Subjects
Month-1, month-2, month-3 and month-7
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
Secondary
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Analysis was performed as per the protocol dataset.
Posted
Geometric Mean
95% Confidence Interval
Titers
month-1, month-2, month-3, month-6 and month-7
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
Secondary
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Analysis was performed as per the protocol dataset.
Posted
Geometric Mean
95% Confidence Interval
Ratio
month-1, month-2, month-3, month-6 and month-7
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
Secondary
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.
Analysis was performed as per the protocol dataset.
Posted
Geometric Mean
95% Confidence Interval
IU/ml
month-1, month-2, month-3, month-6 and month-7
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
Secondary
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen
Analysis was performed as per the protocol dataset.
Posted
Geometric Mean
95% Confidence Interval
Ratio
month-1, month-2, month-3, month-6 and month-7
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
Secondary
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
Analysis was performed as per the safety dataset.
Posted
Number
participants
Throughout the study
ID
Title
Description
OG000
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
OG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
OG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
OG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
OG004
rMenB026
Post-Hoc
Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against M10713 strain at 1 month after second dose of vaccination (Month 3)
Analysis was performed as per the protocol dataset. Only groups rMenB01 and rMenB02 are applicable to this endpoint as the post-hoc outcome was assessed at an interval of 1 month (rMenB01) or 2 months (rMenB02 ) to kill M10713 strain.
Posted
Number
95% Confidence Interval
Percentage of subjects
At one month after second dose (Month 3)
ID
Title
Description
OG000
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
OG001
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
Units
Counts
Participants
OG000
Time Frame
Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
Description
Not provided
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
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
5
128
123
128
EG001
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
4
247
238
247
EG002
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
2
128
126
128
EG003
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
4
247
242
247
EG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
2
127
118
127
EG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
4
253
240
253
EG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
11
373
354
373
EG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
3
128
125
128
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
APPENDICITIS
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected128 at risk
EG0011 affected247 at risk
EG0021 affected128 at risk
EG0031 affected247 at risk
EG0041 affected127 at risk
EG0051 affected253 at risk
EG0062 affected373 at risk
EG0071 affected128 at risk
DYSENTERY
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0011 affected247 at risk
EG0020 affected128 at risk
EG003
MENINGITIS BACTERlAL
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
PNEUMONIA VIRAL
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
SHIGELLAIN FECTION
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
JOINT INJURY
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
LIGAMENT RUPTURE
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
TOXICITY TO VARlOUS AGENTS
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
JUVENILE IDIOPATHIC ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
ADENOMA BENIGN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
BENGIN OVARIAN TUMOUR
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
CONVULSION
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected128 at risk
EG0011 affected247 at risk
EG0020 affected128 at risk
EG003
EPILEPSY
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0011 affected247 at risk
EG0020 affected128 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
PREMATURE LABOUR
Pregnancy, puerperium and perinatal conditions
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected128 at risk
EG0010 affected247 at risk
EG0021 affected128 at risk
EG003
MAJOR DEPRESSION
Psychiatric disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
PANIC ATTACK
Psychiatric disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
SUICIDE ATTEMPT
Psychiatric disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0011 affected247 at risk
EG0020 affected128 at risk
EG003
GLOMERULONEPHRITIS MINIMAL LESION
Renal and urinary disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
TESTICULAR TORSION
Reproductive system and breast disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
ASTHMATIC CRISIS
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
ADENOIDECTOMY
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
TONSILLECTOMY
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected128 at risk
EG0010 affected247 at risk
EG0020 affected128 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
NAUSEA
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00080 events41 affected128 at risk
EG001120 events80 affected247 at risk
EG002109 events51 affected128 at risk
EG003126 events72 affected247 at risk
EG00472 events42 affected127 at risk
EG005156 events89 affected253 at risk
EG006276 events143 affected373 at risk
EG00790 events49 affected128 at risk
INJECTION SITE ERYTHEMA
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG000211 events93 affected128 at risk
EG001338 events162 affected247 at risk
EG002225 events97 affected128 at risk
EG003
INJECTION SITE INDURATION
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG000149 events72 affected128 at risk
EG001240 events130 affected247 at risk
EG002167 events76 affected128 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG000378 events122 affected128 at risk
EG001667 events236 affected247 at risk
EG002396 events124 affected128 at risk
EG003
INJECTION SITE SWELLING
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG000129 events73 affected128 at risk
EG001244 events132 affected247 at risk
EG002172 events81 affected128 at risk
EG003
MALAISE
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG000222 events92 affected128 at risk
EG001371 events181 affected247 at risk
EG002238 events96 affected128 at risk
EG003
PYREXIA
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00017 events12 affected128 at risk
EG00111 events8 affected247 at risk
EG00218 events13 affected128 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0006 events6 affected128 at risk
EG0017 events7 affected247 at risk
EG0025 events5 affected128 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0004 events4 affected128 at risk
EG0018 events7 affected247 at risk
EG0022 events2 affected128 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0009 events9 affected128 at risk
EG00126 events24 affected247 at risk
EG00218 events18 affected128 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0007 events7 affected128 at risk
EG00111 events11 affected247 at risk
EG0026 events5 affected128 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0004 events3 affected128 at risk
EG0015 events5 affected247 at risk
EG0025 events4 affected128 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0004 events4 affected128 at risk
EG0016 events6 affected247 at risk
EG0023 events3 affected128 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG000101 events56 affected128 at risk
EG001131 events76 affected247 at risk
EG002106 events55 affected128 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG000170 events85 affected128 at risk
EG001266 events141 affected247 at risk
EG002187 events91 affected128 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG000185 events79 affected128 at risk
EG001346 events140 affected247 at risk
EG002256 events88 affected128 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
RegistryContactVaccinesUS@novartis.com
ID
Term
D008589
Meningococcal Infections
Ancestor Terms
ID
Term
D016870
Neisseriaceae Infections
D016905
Gram-Negative Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C570015
4CMenB vaccine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0052 subjects
FG0062 subjects
FG0071 subjects
12 subjects
FG00526 subjects
FG00645 subjects
FG0079 subjects
5 subjects
FG0057 subjects
FG00614 subjects
FG0071 subjects
2 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
13.9
± 1.9
BG00413.7± 1.9
BG00513.7± 1.8
BG00613.8± 1.9
BG00713.8± 2
BG00813.8± 1.9
76
BG003138
BG00473
BG005138
BG006199
BG00766
BG008913
Male
BG00052
BG001100
BG00252
BG003109
BG00454
BG005115
BG006174
BG00762
BG008718
231
OG004110
OG005232
OG006334
OG007116
231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006334
ParticipantsOG007116
Title
Measurements
OG00042(33 to 52)
OG00147(40 to 54)
OG00241(32 to 50)
OG00338(32 to 45)
OG00437(28 to 47)
OG00547(40 to 53)
OG00646(41 to 52)
OG00746(36 to 55)
44/76-SL- Mo 1
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006333
ParticipantsOG007115
Title
Measurements
OG00092(85 to 96)
OG00192(88 to 95)
OG00295(89 to 98)
OG003
44/76-SL- Mo 2
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
ParticipantsOG004105
ParticipantsOG005219
ParticipantsOG006307
ParticipantsOG007109
Title
Measurements
OG00088(80 to 93)
OG00192(88 to 95)
OG002100(97 to 100)
OG003
44/76-SL- Mo 3
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002105
ParticipantsOG003215
ParticipantsOG004104
ParticipantsOG005215
ParticipantsOG006303
ParticipantsOG007108
Title
Measurements
OG00084(76 to 90)
OG00188(82 to 92)
OG00299(95 to 100)
OG003
5/99- Mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006334
ParticipantsOG007116
Title
Measurements
OG00029(20 to 38)
OG00141(35 to 48)
OG00228(20 to 38)
OG003
5/99- Mo 1
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006333
ParticipantsOG007115
Title
Measurements
OG00097(92 to 99)
OG00196(93 to 98)
OG00296(90 to 99)
OG003
5/99- Mo 2
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
ParticipantsOG004105
ParticipantsOG005219
ParticipantsOG006308
ParticipantsOG007109
Title
Measurements
OG00095(90 to 98)
OG00194(90 to 97)
OG002100(97 to 100)
OG003
5/99- Mo 3
ParticipantsOG000107
ParticipantsOG001209
ParticipantsOG002105
ParticipantsOG003215
ParticipantsOG004105
ParticipantsOG005215
ParticipantsOG006303
ParticipantsOG007108
Title
Measurements
OG00092(85 to 96)
OG00189(84 to 93)
OG00299(95 to 100)
OG003
NZ98/254-mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006333
ParticipantsOG007116
Title
Measurements
OG00032(24 to 42)
OG00139(33 to 46)
OG00233(24 to 42)
OG003
NZ98/254-mo 1
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006333
ParticipantsOG007115
Title
Measurements
OG00090(83 to 95)
OG00194(90 to 97)
OG00295(89 to 98)
OG003
NZ98/254-mo 2
ParticipantsOG000107
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
ParticipantsOG004105
ParticipantsOG005218
ParticipantsOG006308
ParticipantsOG007109
Title
Measurements
OG00081(73 to 88)
OG00184(74 to 88)
OG00299(95 to 100)
OG003
NZ98/254-mo 3
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002105
ParticipantsOG003215
ParticipantsOG004104
ParticipantsOG005215
ParticipantsOG006302
ParticipantsOG007108
Title
Measurements
OG00080(72 to 87)
OG00176(70 to 82)
OG00297(92 to 99)
OG003
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG000128
OG001247
OG002128
OG003247
OG004127
OG005253
OG006373
OG007128
Title
Denominators
Categories
erythema (local)
Title
Measurements
OG00093
OG001162
OG00295
OG003188
OG00494
OG005172
OG006282
OG00785
Induration (Local)
Title
Measurements
OG00071
OG001130
OG00275
OG003
Swelling (Local)
Title
Measurements
OG00072
OG001132
OG00281
OG003
Pain (Local)
Title
Measurements
OG000122
OG001236
OG002124
OG003
Med.Att Fever (Systemic)
Title
Measurements
OG0001
OG0010
OG0022
OG003
Malaise (Systemic)
Title
Measurements
OG00092
OG001181
OG00296
OG003
Myalgia(Systemic)
Title
Measurements
OG00085
OG001141
OG00291
OG003
Arthralgia(Systemic)
Title
Measurements
OG00055
OG00176
OG00255
OG003
Headache(Systemic)
Title
Measurements
OG00079
OG001139
OG00288
OG003
Nausea(Systemic)
Title
Measurements
OG00041
OG00180
OG00251
OG003
Fever(Systemic)
Title
Measurements
OG00012
OG0018
OG00211
OG003
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG000100
OG001188
OG002100
OG003198
OG00499
OG005201
OG006278
OG007100
Title
Denominators
Categories
44/76-SL- Mo 6
ParticipantsOG000100
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
ParticipantsOG00499
ParticipantsOG005201
ParticipantsOG006278
ParticipantsOG007100
Title
Measurements
OG00076(66 to 84)
OG00172(65 to 79)
OG00293(86 to 97)
OG003
44/76-SL- Mo 7
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00295
ParticipantsOG003186
5/99- Mo 6
ParticipantsOG000100
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
5/99- Mo 7
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00295
ParticipantsOG003187
NZ98/254-mo 6
ParticipantsOG00099
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
NZ98/254-mo 7
ParticipantsOG00086
ParticipantsOG001172
ParticipantsOG00295
ParticipantsOG003187
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG000112
OG001223
OG002113
OG003231
OG004110
OG005232
OG006334
OG007116
Title
Denominators
Categories
44/76-SL- Mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006334
ParticipantsOG007116
Title
Measurements
OG00029(21 to 39)
OG00137(31 to 44)
OG00231(23 to 40)
OG003
44/76-SL- Mo 1
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
44/76-SL- Mo 2
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
44/76-SL- Mo 3
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002105
ParticipantsOG003215
44/76-SL- Mo 6
ParticipantsOG000100
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
44/76-SL- Mo 7
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00295
ParticipantsOG003186
5/99- Mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
5/99- Mo 1
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
5/99- Mo 2
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
5/99- Mo 3
ParticipantsOG000107
ParticipantsOG001209
ParticipantsOG002105
ParticipantsOG003215
5/99- Mo 6
ParticipantsOG000100
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
5/99- Mo 7
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00295
ParticipantsOG003187
NZ98/254 Mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
NZ98/254 Mo 1
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
NZ98/254 Mo 2
ParticipantsOG000107
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
NZ98/254 Mo 3
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002105
ParticipantsOG003215
NZ98/254 Mo 6
ParticipantsOG00099
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
NZ98/254 Mo 7
ParticipantsOG00086
ParticipantsOG001172
ParticipantsOG00295
ParticipantsOG003187
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG000112
OG001223
OG002113
OG003231
OG004110
OG005232
OG006333
OG007115
Title
Denominators
Categories
44/76-SL Mo 1
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006333
ParticipantsOG007115
Title
Measurements
OG00073(64 to 81)
OG00175(69 to 80)
OG00271(61 to 79)
OG003
44/76-SL Mo 2
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002107
ParticipantsOG003222
44/76-SL Mo 3
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002104
ParticipantsOG003215
44/76-SL Mo 7
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00294
ParticipantsOG003186
5/99 Mo 1
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
5/99 Mo 2
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002107
ParticipantsOG003222
5/99 Mo 3
ParticipantsOG000107
ParticipantsOG001209
ParticipantsOG002104
ParticipantsOG003215
5/99- Mo 7
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00294
ParticipantsOG003187
NZ98/254 Mo 1
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
NZ98/254 Mo 2
ParticipantsOG000107
ParticipantsOG001213
ParticipantsOG002107
ParticipantsOG003222
NZ98/254 Mo 3
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002104
ParticipantsOG003215
NZ98/254 Mo 7
ParticipantsOG00086
ParticipantsOG001172
ParticipantsOG00294
ParticipantsOG003187
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG000112
OG001223
OG002113
OG003231
OG004110
OG005232
OG006334
OG007116
Title
Denominators
Categories
44/76 GMT Mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006334
ParticipantsOG007116
Title
Measurements
OG0003.41(2.54 to 4.58)
OG0014.24(3.44 to 5.22)
OG0023.34(2.49 to 4.48)
OG003
44/76 GMT Mo 1
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
44/76 GMT Mo 2
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
44/76 GMT Mo 3
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002105
ParticipantsOG003215
44/76 GMT Mo 6
ParticipantsOG000100
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
44/76 GMT Mo 7
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00295
ParticipantsOG003186
5/99 GMT Mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
5/99 GMT Mo 1
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
5/99 GMT Mo 2
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
5/99 GMT Mo 3
ParticipantsOG000107
ParticipantsOG001209
ParticipantsOG002105
ParticipantsOG003215
5/99 GMT Mo 6
ParticipantsOG000100
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
5/99 GMT Mo 7
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00295
ParticipantsOG003187
NZ98/254 GMT Mo 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
NZ98/254 GMT Mo1
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
NZ98/254 GMT Mo 2
ParticipantsOG000107
ParticipantsOG001213
ParticipantsOG002108
ParticipantsOG003222
NZ98/254 GMT Mo 3
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002105
ParticipantsOG003215
NZ98/254 GMT Mo 6
ParticipantsOG00099
ParticipantsOG001188
ParticipantsOG002100
ParticipantsOG003198
NZ98/254 GMT Mo 7
ParticipantsOG00086
ParticipantsOG001172
ParticipantsOG00295
ParticipantsOG003187
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG000112
OG001223
OG002113
OG003231
OG004110
OG005232
OG006333
OG007115
Title
Denominators
Categories
44/76 GMR Mo 1 to 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
ParticipantsOG004110
ParticipantsOG005232
ParticipantsOG006333
ParticipantsOG007115
Title
Measurements
OG00013(10 to 18)
OG00114(11 to 17)
OG00217(12 to 22)
OG003
44/76 GMR Mo 2 to 0
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002107
ParticipantsOG003222
44/76 GMR Mo 3 to 0
ParticipantsOG000107
ParticipantsOG001208
ParticipantsOG002104
ParticipantsOG003215
44/76 GMR Mo 6 to 0
ParticipantsOG000100
ParticipantsOG001188
ParticipantsOG00299
ParticipantsOG003198
44/76 GMR Mo 7 to 0
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00294
ParticipantsOG003186
44/76 GMR Mo 7 to 6
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00295
ParticipantsOG003186
5/99 GMR Mo 1 to 0
ParticipantsOG000111
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
5/99 GMR Mo 2 to 0
ParticipantsOG000108
ParticipantsOG001213
ParticipantsOG002107
ParticipantsOG003222
5/99 GMR Mo 3 to 0
ParticipantsOG000107
ParticipantsOG001209
ParticipantsOG002104
ParticipantsOG003215
5/99 GMR Mo 6 to 0
ParticipantsOG000100
ParticipantsOG001188
ParticipantsOG00299
ParticipantsOG003198
5/99 GMR Mo 7 to 0
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00294
ParticipantsOG003187
5/99 GMR Mo 7 to 6
ParticipantsOG00086
ParticipantsOG001173
ParticipantsOG00295
ParticipantsOG003187
NZ98/254 GMR Mo 1 to 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
NZ98/254 GMR Mo 2 to 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
NZ98/254 GMR Mo 3 to 0
ParticipantsOG000112
ParticipantsOG001223
ParticipantsOG002113
ParticipantsOG003231
NZ98/254 GMR Mo 6 to 0
ParticipantsOG00099
ParticipantsOG001188
ParticipantsOG00299
ParticipantsOG003198
NZ98/254 GMR Mo 7 to 0
ParticipantsOG00086
ParticipantsOG001172
ParticipantsOG00294
ParticipantsOG003187
NZ98/254 GMR Mo 7 to 6
ParticipantsOG00085
ParticipantsOG001172
ParticipantsOG00295
ParticipantsOG003187
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG00034
OG00135
OG00235
OG00335
OG00435
OG00535
OG00635
OG00735
Title
Denominators
Categories
GMC Mo 0
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00332
ParticipantsOG00435
ParticipantsOG00535
ParticipantsOG00635
ParticipantsOG00735
Title
Measurements
OG00035(25 to 51)
OG00135(25 to 50)
OG00243(30 to 61)
OG003
GMC Mo 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
GMC Mo 2
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00334
GMC Mo 3
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00334
GMC Mo 6
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
GMC Mo 7
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00235
ParticipantsOG00334
OG004
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Units
Counts
Participants
OG00034
OG00135
OG00235
OG00335
OG00435
OG00535
OG00635
OG00735
Title
Denominators
Categories
GMR Mo 1 to 0
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00332
ParticipantsOG00435
ParticipantsOG00535
ParticipantsOG00635
ParticipantsOG00735
Title
Measurements
OG0005.73(3.19 to 9.05)
OG0015.82(3.48 to 9.73)
OG0027.75(4.64 to 13)
OG003
GMR Mo 2 to 0
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00331
GMR Mo 3 to 0
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00331
GMR Mo 6 to 0
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00332
GMR Mo 7 to 0
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00235
ParticipantsOG00331
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
OG005
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
OG006
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
OG007
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.