Study to Assess the Immunological Long-term Persistence o... | NCT02946385 | Trialant
NCT02946385
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Aug 20, 2019Actual
Enrollment
604Actual
Phase
Phase 2
Conditions
Infections, Meningococcal
Interventions
Meningococcal ABCWY Vaccine
Meningococcal B Recombinant vaccine
Countries
Finland
Poland
Protocol Section
Identification Module
NCT ID
NCT02946385
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
205613
Secondary IDs
ID
Type
Description
Link
V102_15E1
Other Identifier
Novartis
2016-002230-69
EudraCT Number
Brief Title
Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
Official Title
A Phase 2b Open-Label Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 Years After the Last Meningococcal Vaccination in Study V102_15 (NCT02212457) and the Response to a Booster Dose of GSK MenABCWY or Meningococcal Serogroup B Vaccines, in Healthy Adolescents
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Aug 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
Nov 15, 2016Actual
Primary Completion Date
Feb 13, 2018Actual
Completion Date
Feb 13, 2018Actual
First Submitted Date
Oct 25, 2016
First Submission Date that Met QC Criteria
Oct 25, 2016
First Posted Date
Oct 27, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 12, 2019
Results First Submitted that Met QC Criteria
Aug 12, 2019
Results First Posted Date
Aug 20, 2019Actual
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
Aug 12, 2019
Last Update Posted Date
Aug 20, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
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 purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at approximately 24 months after the last meningococcal vaccination in the parent study V102_15(NCT02212457), compared with baseline antibody levels in vaccine naïve subjects at similar age at enrolment.
Detailed Description
Naive subjects will be randomized 1:1 to receive MenABCWY or rMenB+OMV at Day 1. No randomization to treatment arm for follow-on subjects is required as vaccine groups remain the same as in the parent study V102_15 (NCT02212457).
Response to a booster dose of MenABCWY vaccine will also be assessed in follow-on subjects who received 2 or 3 doses of MenABCWY (at 0.2-, 0,.6- or 0,.2,.6-month schedules) in the parent study, and will be compared with responses to a single dose of MenABCWY in naive subjects (subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study).
Response to a booster dose of GSK Meningococcal B Recombinant vaccine (rMenB+OMV) will be assessed in subjects who received 2 doses of rMenB+OMV (at 0, 2-month schedule) in the parent study, and will be compared with responses to a single dose of rMenB+OMV in naive subjects.
Conditions Module
Conditions
Infections, Meningococcal
Keywords
meningococcal disease
meningitis
booster
antibody persistence
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
604Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ABCWY_ 0_2 Group
Experimental
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Biological: Meningococcal ABCWY Vaccine
ABCWY_0_2_6 Group
Experimental
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Biological: Meningococcal ABCWY Vaccine
B_0_2 Group
Experimental
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
Biological: Meningococcal B Recombinant vaccine
ABCWY_ 0_6 Group
Experimental
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Biological: Meningococcal ABCWY Vaccine
ABCWY Naive Group
Active Comparator
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Meningococcal ABCWY Vaccine
Biological
Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY_ 0_2 Group, ABCWY_ 0_2_6 Group and ABCWY_ 0_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the percentage of subjects with High-Throughput Human Serum Bactericidal Assay (HT-hSBA) titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects
Secondary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater than or equal to (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Follow-on Participants
Subjects from Finland and Poland previously enrolled in study V102_15 (NCT02212457) who have received all planned meningococcal vaccinations in the study
Who have not received any additional meningococcal vaccination since the last meningococcal vaccination administered in the parent trial.
Who have given written informed consent or assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
Individuals of who the investigator believes can and will comply with the requirements of the protocol.
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Naive Group
Male and female individuals of similar age (approximately 12-20 years) to follow-on subjects from V102_15 (NCT02212457) trial.
Who have not received any meningococcal vaccination since birth
Individuals who have given their written informed consent or assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
Individuals of who the investigator believes can and will comply with the requirements of the protocol.
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria:
Follow-on Participants:
Follow-on individuals not eligible to be enrolled in the study are those with:
History of any meningococcal vaccine administration since last meningococcal vaccination administered in V102_15 (NCT02212457) parent study.
Current or previous, confirmed or suspected disease caused by N. meningitidis, since termination from parent study.
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.
If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
Pregnancy or breast-feeding
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
Progressive, unstable or uncontrolled clinical conditions.
Any confirmed or suspected condition with impaired/altered function of immune system.
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 20 mg/day. Inhaled, intranasal and topical steroids are allowed).
Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the 3 months prior to study enrolment.
Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
Administration of any vaccine within 14 days or 28 days prior to enrollment in the study, or within 7 days after vaccination in the study.
Clinical conditions representing a contraindication to intramuscular vaccination and/or blood draws.
Who have received systemic antibiotic treatment within 3 days prior to any blood draw
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Naive Individuals
Naive individuals not eligible to be enrolled in the study are those with:
History of any meningococcal vaccine administration since birth.
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.
If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
Pregnancy or breast-feeding.
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
Progressive, unstable or uncontrolled clinical conditions.
Any confirmed or suspected condition with impaired/altered function of immune system.
Chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to the study enrolment. (For corticosteroids, this means prednisone, or equivalent, ≥ 20 mg/kg/day. Inhaled, intranasal and topical steroids are allowed).
Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
Individuals who are part of study personnel or close family members conducting this study.
Administration of any vaccine within 14 days or 28 days prior to enrollment in the study, or within 7 days after first vaccination, and/or planned use of any vaccine 7 days prior to and 7 days after second vaccination.
Clinical conditions representing a contraindication to intramuscular vaccination and/or blood draws.
Who have received systemic antibiotic treatment within 3 days prior to any blood draw
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
20 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Espoo
02230
Finland
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participant flow,baseline characteristics & immunogenicity analyses were performed on "randomized" population & Safety analysis on "treated" population.2 subjects from Naïve_ABCWY group received rMenB+OMV vaccine & not MenABCWY.Hence,number of subjects analyzed in Naïve_B & Naive_ABCWY groups in treated population differ from randomized population
Recruitment Details
All subjects enrolled in the study started the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
FG001
ABCWY_0_2
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
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 4, 2018
Aug 12, 2019
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: Meningococcal ABCWY Vaccine
rMenB+OMV Naive Group
Active Comparator
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Biological: Meningococcal B Recombinant vaccine
ABCWY Naive Group
ABCWY_ 0_2 Group
ABCWY_ 0_6 Group
ABCWY_0_2_6 Group
MenABCWY
Meningococcal B Recombinant vaccine
Biological
Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B_0_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group.
B_0_2 Group
rMenB+OMV Naive Group
rMenB+OMV
Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
At Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMVl vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group
hSBA GMTs Against Each of Four Serogroup B Test Strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1
The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
At Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).
within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)
Number of Subjects With Any Unsolicited AEs Within 30 Minutes After Vaccination
An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination. Note: unsolicited AEs within 30 minutes were not collected
Within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Assessed solicited symptoms were pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).
At Day 1 (6 hours) to Day 7 after vaccination at Day 1 (for all subjects) and Day 61 to Day 67 (for naive subjects only)
Number of Subjects With Unsolicited AEs, 30 Days After Any Vaccination
An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination.
From Day 1 to Day 31 for all subjects and Day 61 to Day 91 for naive subjects
Number of Subjects With Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal
Serious adverse events (SAEs), medically attended adverse events and AEs leading to withdrawal are reported. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: -Death, -Is life-threatening,-Required or prolonged hospitalization, -Persistent or significant disability/incapacity, -Congenital anomaly/or birth defect, -An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
During the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects)
Helsinki
00100
Finland
GSK Investigational Site
Helsinki
00930
Finland
GSK Investigational Site
Jarvenpaa
04400
Finland
GSK Investigational Site
Kokkola
67100
Finland
GSK Investigational Site
Oulu
90220
Finland
GSK Investigational Site
Pori
28100
Finland
GSK Investigational Site
Seinäjoki
60100
Finland
GSK Investigational Site
Tampere
33100
Finland
GSK Investigational Site
Turku
20520
Finland
GSK Investigational Site
Bydgoszcz
85-796
Poland
GSK Investigational Site
Dębica
39-200
Poland
GSK Investigational Site
Gdansk
80 542
Poland
GSK Investigational Site
Gdansk
80-546
Poland
GSK Investigational Site
Lodz
91 347
Poland
GSK Investigational Site
Siemianowice ÅšlÄ…skie
41-103
Poland
GSK Investigational Site
Wroclaw
50-368
Poland
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
FG002
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
FG003
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
FG004
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
FG005
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
FG000126 subjects
FG001127 subjects
FG00299 subjects
FG00374 subjects
FG004101 subjects
FG00577 subjects
COMPLETED
FG000126 subjects
FG001127 subjects
FG00296 subjects
FG00374 subjects
FG00499 subjects
FG00576 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0042 subjects
FG0051 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0042 subjects
FG0051 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
BG001
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
BG002
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
BG003
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
BG004
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
BG005
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
BG006
TOTAL
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000126
BG001127
BG00299
BG00374
BG004101
BG00577
BG006604
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
BG00016.8± 3.06
BG00116.6± 3.15
BG00216.2± 2.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00082
BG00169
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
AMERICAN INDIAN OR ALASKA NATIVE
Title
Measurements
BG0000
BG0010
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 Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the percentage of subjects with High-Throughput Human Serum Bactericidal Assay (HT-hSBA) titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Subjects in full analysis set(FAS) persistence(24 months after last vaccination in V102_15/Day 1)who were randomized(if naive) & provided evaluable serum sample with hSBA results for atleast 1 serogroup B test strain/serogroups A,C,W/Y at Day 1 in extension study.Subjects in group B_0_2 did not receive MenACWY vaccination in the parent study
Posted
Number
95% Confidence Interval
Percentage of subjects
At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG004
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
Units
Counts
Participants
OG000127
OG00175
OG00274
OG003
Title
Denominators
Categories
Meningitis B M14459 Ab
ParticipantsOG000121
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG003
Primary
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Subjects in full analysis set(FAS) persistence(24 months after last vaccination in V102_15/Day 1)who were randomized(if naive) & provided evaluable serum sample with hSBA results for atleast 1 serogroup B test strain/serogroups A,C,W/Y at Day 1 in extension study.Subjects in group B_0_2 did not receive MenACWY vaccination in the parent study.
Posted
Geometric Mean
95% Confidence Interval
Titers
At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Secondary
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater than or equal to (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.
Posted
Number
95% Confidence Interval
Percentage of subjects
Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Secondary
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.
Posted
Number
95% Confidence Interval
Percentage of subjects
Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
Secondary
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Secondary
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
All subjects in FAS immunogenicity(Days 6 and 31, after booster [follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Secondary
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Secondary
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Secondary
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.
Posted
Number
95% Confidence Interval
Percentage of subjects
Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMVl vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group
ID
Title
Description
OG000
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG001
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Secondary
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.
Posted
Number
95% Confidence Interval
Percentage of subjects
Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group
ID
Title
Description
OG000
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG001
Naive_B
Secondary
hSBA GMTs Against Each of Four Serogroup B Test Strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1
The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group
ID
Title
Description
OG000
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG001
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Secondary
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group
ID
Title
Description
OG000
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG001
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Secondary
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group
ID
Title
Description
OG000
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG001
Secondary
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group
ID
Title
Description
OG000
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG001
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Secondary
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).
Analysis was done on subjects in Solicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of the subject's randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination solicited adverse events data
Posted
Count of Participants
Participants
within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG002
ABCWY_0_6
Secondary
Number of Subjects With Any Unsolicited AEs Within 30 Minutes After Vaccination
An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination. Note: unsolicited AEs within 30 minutes were not collected
Analysis was to be done on subjects in Unsolicited Safety Set but was not performed as AEs within 30 minutes after vaccination were not collected.
Posted
Within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study.
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study.
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Secondary
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Assessed solicited symptoms were pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).
Analysis was done on subjects in Solicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of the subject's randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination solicited adverse events data
Posted
Count of Participants
Participants
At Day 1 (6 hours) to Day 7 after vaccination at Day 1 (for all subjects) and Day 61 to Day 67 (for naive subjects only)
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG002
ABCWY_0_6
Secondary
Number of Subjects With Unsolicited AEs, 30 Days After Any Vaccination
An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination.
Analysis was done on subjects in Unsolicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of subject's randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination unsolicited adverse events data
Posted
Count of Participants
Participants
From Day 1 to Day 31 for all subjects and Day 61 to Day 91 for naive subjects
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG002
ABCWY_0_6
Secondary
Number of Subjects With Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal
Serious adverse events (SAEs), medically attended adverse events and AEs leading to withdrawal are reported. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: -Death, -Is life-threatening,-Required or prolonged hospitalization, -Persistent or significant disability/incapacity, -Congenital anomaly/or birth defect, -An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Analysis was done on subjects in Unsolicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of subject's randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination unsolicited adverse events data
Posted
Count of Participants
Participants
During the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects)
ID
Title
Description
OG000
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG001
ABCWY_0_2_6
Time Frame
Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Description
Safety analysis was performed on the treated population.
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_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
0
126
2
126
120
126
EG001
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
0
127
0
127
116
127
EG002
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
0
101
1
101
99
101
EG003
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
0
74
0
74
67
74
EG004
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
0
99
0
99
96
99
EG005
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
0
77
0
77
70
77
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Depression
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG0030 events0 affected74 at risk
EG0040 events0 affected99 at risk
EG0050 events0 affected77 at risk
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG0030 events0 affected74 at risk
EG0040 events0 affected99 at risk
EG0050 events0 affected77 at risk
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0012 events2 affected127 at risk
EG0022 events2 affected101 at risk
EG003
Allergy to animal
Immune system disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Anxiety
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG00033 events15 affected126 at risk
EG00121 events13 affected127 at risk
EG00233 events17 affected101 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Body temperature increased
Investigations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0022 events2 affected101 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Chills
General disorders
Systematic Assessment
EG00050 events27 affected126 at risk
EG00139 events23 affected127 at risk
EG00262 events26 affected101 at risk
EG003
Chlamydial infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Conjunctivitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Cystitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG00039 events20 affected126 at risk
EG00115 events15 affected127 at risk
EG00238 events16 affected101 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0011 events1 affected127 at risk
EG0025 events3 affected101 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0002 events1 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Dyssomnia
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Ear infection
Infections and infestations
Systematic Assessment
EG0002 events2 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG000164 events64 affected126 at risk
EG001114 events58 affected127 at risk
EG002206 events55 affected101 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0012 events2 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Hangover
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG000132 events62 affected126 at risk
EG00196 events55 affected127 at risk
EG002160 events46 affected101 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Hypersensitivity
Immune system disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Hypoaesthesia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Infectious mononucleosis
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0004 events4 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Influenza like illness
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Injection site erythema
General disorders
Systematic Assessment
EG000129 events59 affected126 at risk
EG001100 events50 affected127 at risk
EG002137 events49 affected101 at risk
EG003
Injection site haemorrhage
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0022 events2 affected101 at risk
EG003
Injection site induration
General disorders
Systematic Assessment
EG000117 events40 affected126 at risk
EG001107 events43 affected127 at risk
EG002172 events43 affected101 at risk
EG003
Injection site pain
General disorders
Systematic Assessment
EG000421 events116 affected126 at risk
EG001321 events108 affected127 at risk
EG002683 events93 affected101 at risk
EG003
Injection site pruritus
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Injection site rash
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Injection site reaction
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Injection site swelling
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Injection site warmth
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Malaise
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Migraine
Nervous system disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Migraine-triggered seizure
Nervous system disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG00042 events22 affected126 at risk
EG00136 events26 affected127 at risk
EG00240 events21 affected101 at risk
EG003
Nail injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG0005 events4 affected126 at risk
EG0011 events1 affected127 at risk
EG0024 events3 affected101 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG00039 events26 affected126 at risk
EG00120 events13 affected127 at risk
EG00239 events21 affected101 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Noninfective sialoadenitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0022 events2 affected101 at risk
EG003
Otitis media
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Peritonsillar abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0018 events8 affected127 at risk
EG0022 events2 affected101 at risk
EG003
Pharyngitis bacterial
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0022 events2 affected101 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Pyelonephritis
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0007 events7 affected126 at risk
EG00111 events10 affected127 at risk
EG0026 events6 affected101 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Respiratory tract infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Respiratory tract infection viral
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Retching
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Rhinitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Scrotal varicose veins
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Seasonal allergy
Immune system disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Sinus polyp
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0002 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0022 events2 affected101 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Spinal flattening
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Swelling of eyelid
Eye disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Syncope
Nervous system disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Tonsillitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0014 events3 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Tonsillitis bacterial
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Tonsillitis streptococcal
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Tooth impacted
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Tooth infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0022 events2 affected101 at risk
EG003
Tooth loss
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Toothache
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Tracheitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0005 events5 affected126 at risk
EG0018 events8 affected127 at risk
EG00213 events11 affected101 at risk
EG003
Upper respiratory tract irritation
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected126 at risk
EG0011 events1 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Vaccination site pain
General disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Vertigo
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0022 events1 affected101 at risk
EG003
Viral pharyngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Vision blurred
Eye disorders
Systematic Assessment
EG0001 events1 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 at risk
EG003
Wound infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0021 events1 affected101 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected126 at risk
EG0010 events0 affected127 at risk
EG0020 events0 affected101 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
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG004
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
Units
Counts
Participants
OG000127
OG00175
OG00274
OG003125
OG004198
Title
Denominators
Categories
Meningitis B M14459 Ab
ParticipantsOG000121
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG003123
ParticipantsOG004198
Title
Measurements
OG0002.05(1.68 to 2.50)
OG0012(1.55 to 2.57)
OG0022.55(1.98 to 3.30)
OG003
Meningitis B 96217 Ab
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00274
ParticipantsOG003124
Meningitis B NZ98/254 Ab
ParticipantsOG000127
ParticipantsOG00175
ParticipantsOG00274
ParticipantsOG003124
Meningitis B M07-0241084 Ab
ParticipantsOG000126
ParticipantsOG00175
ParticipantsOG00273
ParticipantsOG003125
Meningitis A human Ab
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00274
ParticipantsOG0030
Meningitis C human Ab
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00274
ParticipantsOG0030
Meningitis W human Ab
ParticipantsOG000127
ParticipantsOG00175
ParticipantsOG00272
ParticipantsOG0030
Meningitis Y human Ab
ParticipantsOG000126
ParticipantsOG00173
ParticipantsOG00273
ParticipantsOG0030
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
Units
Counts
Participants
OG000127
OG00177
OG00273
OG003100
Title
Denominators
Categories
Meningitis B M14459 Ab
ParticipantsOG000126
ParticipantsOG00175
ParticipantsOG00273
ParticipantsOG003100
Title
Measurements
OG00087(79.3 to 91.9)
OG00185(75.3 to 92.4)
OG00295(86.6 to 98.5)
OG003
Meningitis B 96217 Ab
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00273
ParticipantsOG003100
Meningitis B NZ98/254 Ab
ParticipantsOG000127
ParticipantsOG00176
ParticipantsOG00272
ParticipantsOG003100
Meningitis B M07-0241084 Ab
ParticipantsOG000126
ParticipantsOG00177
ParticipantsOG00273
ParticipantsOG003100
Meningitis A human Ab
ParticipantsOG000125
ParticipantsOG00177
ParticipantsOG00273
ParticipantsOG00398
Meningitis C human Ab
ParticipantsOG000127
ParticipantsOG00175
ParticipantsOG00273
ParticipantsOG003100
Meningitis W human Ab
ParticipantsOG000124
ParticipantsOG00174
ParticipantsOG00273
ParticipantsOG003100
Meningitis Y human Ab
ParticipantsOG000127
ParticipantsOG00176
ParticipantsOG00273
ParticipantsOG00398
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
Units
Counts
Participants
OG000127
OG00175
OG00273
OG00399
Title
Denominators
Categories
Meningitis B M14459 Ab
ParticipantsOG000120
ParticipantsOG00173
ParticipantsOG00272
ParticipantsOG00399
Title
Measurements
OG00054(44.8 to 63.3)
OG00149(37.4 to 61.3)
OG00265(53.1 to 76.1)
OG003
Meningitis B 96217 Ab
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00273
ParticipantsOG00399
Meningitis B NZ98/254 Ab
ParticipantsOG000127
ParticipantsOG00175
ParticipantsOG00272
ParticipantsOG00399
Meningitis B M07-0241084 Ab
ParticipantsOG000125
ParticipantsOG00175
ParticipantsOG00272
ParticipantsOG00399
Meningitis A human Ab
ParticipantsOG000123
ParticipantsOG00172
ParticipantsOG00273
ParticipantsOG00397
Meningitis C human Ab
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00273
ParticipantsOG00399
Meningitis W human Ab
ParticipantsOG000124
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00397
Meningitis Y human Ab
ParticipantsOG000126
ParticipantsOG00173
ParticipantsOG00272
ParticipantsOG00396
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
Units
Counts
Participants
OG000127
OG00177
OG00273
OG003100
Title
Denominators
Categories
Meningitis B M14459 Ab
ParticipantsOG000126
ParticipantsOG00175
ParticipantsOG00273
ParticipantsOG003100
Title
Measurements
OG00032(25 to 41)
OG00130(22 to 42)
OG00261(44 to 85)
OG003
Meningitis B 96217 Ab
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00273
ParticipantsOG003100
Meningitis B NZ98/254 Ab
ParticipantsOG000127
ParticipantsOG00176
ParticipantsOG00272
ParticipantsOG003100
Meningitis B M07-0241084 Ab
ParticipantsOG000126
ParticipantsOG00177
ParticipantsOG00273
ParticipantsOG003100
Meningitis A human Ab
ParticipantsOG000125
ParticipantsOG00177
ParticipantsOG00273
ParticipantsOG00398
Meningitis C human Ab
ParticipantsOG000127
ParticipantsOG00175
ParticipantsOG00273
ParticipantsOG003100
Meningitis W human Ab
ParticipantsOG000124
ParticipantsOG00174
ParticipantsOG00273
ParticipantsOG003100
Meningitis Y human Ab
ParticipantsOG000127
ParticipantsOG00176
ParticipantsOG00273
ParticipantsOG00398
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
Units
Counts
Participants
OG000127
OG00175
OG00272
OG00396
Title
Denominators
Categories
Meningitis B M14459 Ab, Day 1
ParticipantsOG000119
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00394
Title
Measurements
OG00018(12.0 to 26.6)
OG00117(8.9 to 27.3)
OG00226(16.0 to 37.6)
OG003
Meningitis B M14459 Ab, Day 6 Post
ParticipantsOG000119
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00394
Meningitis B M14459 Ab, One month Post
ParticipantsOG000119
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00394
Meningitis B 96217 Ab, Day 1
ParticipantsOG000125
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00396
Meningitis B 96217 Ab, Day 6 Post
ParticipantsOG000125
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00396
Meningitis B 96217 Ab, One month Post
ParticipantsOG000125
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00396
Meningitis B NZ98/254 Ab, Day 1
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00271
ParticipantsOG00394
Meningitis B NZ98/254 Ab, Day 6 Post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00271
ParticipantsOG00394
Meningitis B NZ98/254 Ab, One month Post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00271
ParticipantsOG00394
Meningitis B M07-0241084 Ab, Day 1
ParticipantsOG000124
ParticipantsOG00175
ParticipantsOG00271
ParticipantsOG00395
Meningitis B M07-0241084 Ab, Day 6 Post
ParticipantsOG000124
ParticipantsOG00175
ParticipantsOG00271
ParticipantsOG00395
Meningitis B M07-0241084, One month Post
ParticipantsOG000124
ParticipantsOG00175
ParticipantsOG00271
ParticipantsOG00395
Meningitis A human Ab, Day 1
ParticipantsOG000122
ParticipantsOG00171
ParticipantsOG00272
ParticipantsOG00393
Meningitis A human Ab, Day 6 Post
ParticipantsOG000122
ParticipantsOG00171
ParticipantsOG00272
ParticipantsOG00393
Meningitis A human Ab, One month Post
ParticipantsOG000122
ParticipantsOG00171
ParticipantsOG00272
ParticipantsOG00393
Meningitis C human Ab, Day 1
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00395
Meningitis C human Ab, Day 6 Post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00395
Meningitis C human Ab, One month Post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00395
Meningitis W human Ab, Day 1
ParticipantsOG000121
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00393
Meningitis W human Ab, Day 6 Post
ParticipantsOG000121
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00393
Meningitis W human Ab, One month Post
ParticipantsOG000121
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00393
Meningitis Y human Ab, Day 1
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00394
Meningitis Y human Ab, Day 6 Post
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00394
Meningitis Y human Ab, One month Post
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00394
OG001
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
Units
Counts
Participants
OG000127
OG00175
OG00272
OG00396
Title
Denominators
Categories
Meningitis B M14459 Ab, Day 6 Post vacc
ParticipantsOG000119
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00394
Title
Measurements
OG00026(18.4 to 34.9)
OG00136(25.1 to 48.3)
OG00250(37.8 to 62.2)
OG003
Meningitis B M14459 Ab, One month Post vacc
ParticipantsOG000119
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00394
Meningitis B 96217 Ab, Day 6 Post
ParticipantsOG000125
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00396
Meningitis B 96217 Ab, One month Post
ParticipantsOG000125
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00396
Meningitis B NZ98/254 Ab, Day 6 Post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00271
ParticipantsOG00394
Meningitis B NZ98/254 Ab, One month Post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00271
ParticipantsOG00394
Meningitis B M07-0241084 Ab, Day 6 Post
ParticipantsOG000124
ParticipantsOG00175
ParticipantsOG00271
ParticipantsOG00395
Meningitis B M07-0241084, One month Post
ParticipantsOG000124
ParticipantsOG00175
ParticipantsOG00271
ParticipantsOG00395
Meningitis A human Ab, Day 6 Post
ParticipantsOG000122
ParticipantsOG00171
ParticipantsOG00272
ParticipantsOG00393
Meningitis A human Ab, One month Post
ParticipantsOG000122
ParticipantsOG00171
ParticipantsOG00272
ParticipantsOG00393
Meningitis C human Ab, Day 6 Post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00395
Meningitis C human Ab, One month Post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00395
Meningitis W human Ab, Day 6 Post
ParticipantsOG000121
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00393
Meningitis W human Ab, One month Post
ParticipantsOG000121
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00393
Meningitis Y human Ab, Day 6 Post
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00394
Meningitis Y human Ab, One month Post
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00394
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
Units
Counts
Participants
OG000127
OG00175
OG00272
OG00396
Title
Denominators
Categories
Meningitis B M14459 Ab, Day 1
ParticipantsOG000119
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00394
Title
Measurements
OG0002.08(1.70 to 2.54)
OG0012.04(1.58 to 2.64)
OG0022.62(2.02 to 3.41)
OG003
Meningitis B M14459 Ab, Day 6 post
ParticipantsOG000119
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00394
Meningitis B M14459 Ab, One month post
ParticipantsOG000119
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00394
Meningitis B 96217 Ab, Day 1
ParticipantsOG000125
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00396
Meningitis B 96217 Ab, Day 6 post
ParticipantsOG000125
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00396
Meningitis B 96217 Ab, One month post
ParticipantsOG000125
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00396
Meningitis B NZ98/254 Ab, Day 1
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00271
ParticipantsOG00394
Meningitis B NZ98/254 Ab, Day 6 post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00271
ParticipantsOG00394
Meningitis B NZ98/254 Ab, One month post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00271
ParticipantsOG00394
Meningitis B M07-0241084 Ab, Day 1
ParticipantsOG000124
ParticipantsOG00175
ParticipantsOG00271
ParticipantsOG00395
Meningitis B M07-0241084 Ab, Day 6 post
ParticipantsOG000124
ParticipantsOG00175
ParticipantsOG00271
ParticipantsOG00395
Meningitis B M07-0241084 Ab, One month
ParticipantsOG000124
ParticipantsOG00175
ParticipantsOG00271
ParticipantsOG00395
Meningitis A human Ab, Day 1
ParticipantsOG000122
ParticipantsOG00171
ParticipantsOG00272
ParticipantsOG00393
Meningitis A human Ab, Day 6 post
ParticipantsOG000122
ParticipantsOG00171
ParticipantsOG00272
ParticipantsOG00393
Meningitis A human Ab, One month post
ParticipantsOG000122
ParticipantsOG00171
ParticipantsOG00272
ParticipantsOG00393
Meningitis C human Ab, Day 1
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00395
Meningitis C human Ab, Day 6 post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00395
Meningitis C human Ab, One month post
ParticipantsOG000127
ParticipantsOG00174
ParticipantsOG00272
ParticipantsOG00395
Meningitis W human Ab, Day 1
ParticipantsOG000121
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00393
Meningitis W human Ab, Day 6 post
ParticipantsOG000121
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00393
Meningitis W human Ab, One month post
ParticipantsOG000121
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00393
Meningitis Y human Ab, Day 1
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00394
Meningitis Y human Ab, Day 6 post
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00394
Meningitis Y human Ab, One month post
ParticipantsOG000125
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00394
Units
Counts
Participants
OG000124
OG00198
Title
Denominators
Categories
Meningitis B M14459 Ab
ParticipantsOG000123
ParticipantsOG00196
Title
Measurements
OG00094(88.6 to 97.7)
OG00128(19.4 to 38.2)
Meningitis B 96217 Ab
ParticipantsOG000124
ParticipantsOG00198
Title
Measurements
OG000100(97.1 to 100.0)
OG001
Meningitis B NZ98/254 Ab
ParticipantsOG000124
ParticipantsOG00198
Title
Measurements
OG00087(79.9 to 92.4)
OG001
Meningitis B M07-0241084 Ab
ParticipantsOG000124
ParticipantsOG00198
Title
Measurements
OG00095(89.8 to 98.2)
OG001
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Units
Counts
Participants
OG000123
OG00197
Title
Denominators
Categories
Meningitis B M14459 Ab
ParticipantsOG000120
ParticipantsOG00195
Title
Measurements
OG00067(57.5 to 75.0)
OG00115(8.3 to 23.5)
Meningitis B 96217 Ab
ParticipantsOG000122
ParticipantsOG00197
Title
Measurements
OG00097(91.8 to 99.1)
OG001
Meningitis B NZ98/254 Ab
ParticipantsOG000122
ParticipantsOG00197
Title
Measurements
OG00040(31.4 to 49.4)
OG001
Meningitis B M07-0241084 Ab
ParticipantsOG000123
ParticipantsOG00195
Title
Measurements
OG00053(43.6 to 61.9)
OG001
Units
Counts
Participants
OG000124
OG00198
Title
Denominators
Categories
Meningitis B M14459 Ab
ParticipantsOG000123
ParticipantsOG00196
Title
Measurements
OG00050(39 to 65)
OG0013.48(2.60 to 4.65)
Meningitis B 96217 Ab
ParticipantsOG000124
ParticipantsOG00198
Title
Measurements
OG000820(658 to 1023)
OG001
Meningitis B NZ98/254 Ab
ParticipantsOG000124
ParticipantsOG00198
Title
Measurements
OG00027(21 to 35)
OG001
Meningitis B M07-0241084 Ab
ParticipantsOG000124
ParticipantsOG00198
Title
Measurements
OG00059(47 to 74)
OG001
Units
Counts
Participants
OG000122
OG00194
Title
Denominators
Categories
Meningitis B 96217 Ab, Day 1
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG00082(73.8 to 88.2)
OG00136(26.5 to 46.7)
Meningitis B 96217 Ab, Day 6 Post
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG00098(92.9 to 99.5)
OG001
Meningitis B 96217 Ab, One month Post
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG000100(97.0 to 100.0)
OG001
Meningitis B M07-0241084 Ab, Day 1
ParticipantsOG000122
ParticipantsOG00192
Title
Measurements
OG00028(20.1 to 36.7)
OG001
Meningitis B M07-0241084 Ab, Day 6 Post
ParticipantsOG000122
ParticipantsOG00192
Title
Measurements
OG00070(60.7 to 77.7)
OG001
Meningitis B M07-0241084, One month Post
ParticipantsOG000122
ParticipantsOG00192
Title
Measurements
OG00095(89.6 to 98.2)
OG001
Meningitis B M14459 Ab, Day 1
ParticipantsOG000119
ParticipantsOG00194
Title
Measurements
OG00018(11.3 to 25.7)
OG001
Meningitis B M14459 Ab, Day 6 Post
ParticipantsOG000119
ParticipantsOG00194
Title
Measurements
OG00070(60.7 to 77.8)
OG001
Meningitis B M14459 Ab, One month Post
ParticipantsOG000119
ParticipantsOG00194
Title
Measurements
OG00094(88.3 to 97.6)
OG001
Meningitis B NZ98/254 Ab, Day 1
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG00016(9.7 to 23.4)
OG001
Meningitis B NZ98/254 Ab, Day 6 Post
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG00049(39.6 to 58.0)
OG001
Meningitis B NZ98/254 Ab, One month Post
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG00087(79.4 to 92.2)
OG001
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Units
Counts
Participants
OG000116
OG00178
Title
Denominators
Categories
Meningitis B M14459 Ab, Day 6 Post
ParticipantsOG000113
ParticipantsOG00177
Title
Measurements
OG00034(25.0 to 43.1)
OG00122(13.4 to 33.0)
Meningitis B M14459 Ab, One month Post
ParticipantsOG000113
ParticipantsOG00177
Title
Measurements
OG00066(56.9 to 75.0)
OG001
Meningitis B 96217 Ab, Day 6 Post
ParticipantsOG000116
ParticipantsOG00177
Title
Measurements
OG00078(69.9 to 85.5)
OG001
Meningitis B 96217 Ab, One month Post
ParticipantsOG000116
ParticipantsOG00177
Title
Measurements
OG00097(92.6 to 99.5)
OG001
Meningitis B NZ98/254 Ab, Day 6 Post
ParticipantsOG000115
ParticipantsOG00178
Title
Measurements
OG00013(7.5 to 20.6)
OG001
Meningitis B NZ98/254 Ab, One month Post
ParticipantsOG000115
ParticipantsOG00178
Title
Measurements
OG00041(31.8 to 50.4)
OG001
Meningitis B M07-0241084 Ab, Day 6 Post
ParticipantsOG000116
ParticipantsOG00176
Title
Measurements
OG00021(13.7 to 29.2)
OG001
Meningitis B M07-0241084, One month Post
ParticipantsOG000116
ParticipantsOG00176
Title
Measurements
OG00053(43.1 to 61.9)
OG001
Units
Counts
Participants
OG000122
OG00194
Title
Denominators
Categories
Meningitis B M14459 Ab, Day 1
ParticipantsOG000119
ParticipantsOG00194
Title
Measurements
OG0002.04(1.67 to 2.49)
OG0011.18(0.94 to 1.47)
Meningitis B M14459 Ab, Day 6 post
ParticipantsOG000119
ParticipantsOG00194
Title
Measurements
OG00014(11 to 19)
OG001
Meningitis B M14459 Ab, One month post
ParticipantsOG000119
ParticipantsOG00194
Title
Measurements
OG00049(38 to 63)
OG001
Meningitis B 96217 Ab, Day 1
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG00020(15 to 26)
OG001
Meningitis B 96217 Ab, Day 6 post
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG000341(259 to 448)
OG001
Meningitis B 96217 Ab, One month post
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG000822(692 to 975)
OG001
Meningitis B NZ98/254 Ab, Day 1
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG0001.72(1.41 to 2.09)
OG001
Meningitis B NZ98/254 Ab, Day 6 post
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG0006.39(4.83 to 8.45)
OG001
Meningitis B NZ98/254 Ab, One month post
ParticipantsOG000121
ParticipantsOG00194
Title
Measurements
OG00027(21 to 34)
OG001
Meningitis B M07-0241084 Ab, Day 1
ParticipantsOG000122
ParticipantsOG00192
Title
Measurements
OG0004.24(3.30 to 5.45)
OG001
Meningitis B M07-0241084 Ab, Day 6 post
ParticipantsOG000122
ParticipantsOG00192
Title
Measurements
OG00017(13 to 21)
OG001
Meningitis B M07-0241084 Ab, One month post
ParticipantsOG000122
ParticipantsOG00192
Title
Measurements
OG00059(47 to 72)
OG001
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG004
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
OG005
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Units
Counts
Participants
OG000127
OG00177
OG00274
OG003126
OG00499
OG005101
Title
Denominators
Categories
Local: Erythema
ParticipantsOG000125
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003125
ParticipantsOG00499
ParticipantsOG005101
Title
Measurements
OG0001
OG0011
OG0021
OG003
Local: Induration
ParticipantsOG000126
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Local: Pain
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Systemic: Arthralgia
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Systemic: Chills
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Systemic: Fatigue
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Systemic: Fever
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Systemic: Headache
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Systemic: Loss Of Appetite
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Systemic: Myalgia
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Systemic: Nausea
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003125
Indicator: Prevention Of Pain / Fever
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
Indicator: Treatment Of Pain / Fever
ParticipantsOG000127
ParticipantsOG00177
ParticipantsOG00274
ParticipantsOG003126
OG003
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG004
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
OG005
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG004
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
OG005
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Units
Counts
Participants
OG000127
OG00177
OG00274
OG003126
OG00499
OG005101
Title
Denominators
Categories
Local: Erythema
Title
Measurements
OG00022
OG00110
OG00214
OG00322
OG00423
OG00520
Local: Induration
Title
Measurements
OG00018
OG00114
OG0026
OG003
Local: Pain
Title
Measurements
OG000108
OG00167
OG00264
OG003
Systemic: Arthralgia
Title
Measurements
OG00012
OG0015
OG0029
OG003
Systemic: Chills
Title
Measurements
OG00023
OG0018
OG00212
OG003
Systemic: Fatigue
Title
Measurements
OG00058
OG00133
OG00231
OG003
Systemic: Fever
Title
Measurements
OG0008
OG0013
OG0021
OG003
Systemic: Headache
Title
Measurements
OG00055
OG00119
OG00228
OG003
Systemic: Loss Of Appetite
Title
Measurements
OG00015
OG0019
OG0027
OG003
Systemic: Myalgia
Title
Measurements
OG00026
OG00113
OG00214
OG003
Systemic: Nausea
Title
Measurements
OG00013
OG0018
OG0028
OG003
Indicator: Prevention Of Pain / Fever
Title
Measurements
OG00021
OG0018
OG0028
OG003
Indicator: Treatment Of Pain / Fever
Title
Measurements
OG00037
OG00118
OG00219
OG003
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG004
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
OG005
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
Units
Counts
Participants
OG000127
OG00177
OG00274
OG003126
OG00499
OG005101
Title
Denominators
Categories
Title
Measurements
OG00027
OG00112
OG00210
OG00326
OG00440
OG00536
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG002
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
OG003
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
OG004
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
OG005
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study