Persistence of Antibody Levels and Response to Fifth or T... | NCT01717638 | Trialant
NCT01717638
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Jan 13, 2015Estimated
Enrollment
805Actual
Phase
Phase 3
Conditions
Meningococcal Disease
Meningococcal Meningitis
Interventions
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Countries
Czechia
Italy
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01717638
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V72P12E2
Secondary IDs
ID
Type
Description
Link
2011-004931-30
EudraCT Number
Brief Title
Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1
Official Title
A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Dec 2014
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 2012
Primary Completion Date
Sep 2013Actual
Completion Date
Oct 2013Actual
First Submitted Date
Oct 18, 2012
First Submission Date that Met QC Criteria
Oct 26, 2012
First Posted Date
Oct 30, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 1, 2014
Results First Submitted that Met QC Criteria
Dec 29, 2014
Results First Posted Date
Jan 13, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 29, 2014
Last Update Posted Date
Jan 13, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second extension study is to explore the bactericidal antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV NZ administered to toddlers as part of their respective vaccination courses in study V72P12E1.
In addition, this study will characterize the antibody response to a fifth dose boost in all children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age (in parent study V72P12, NCT00721396), and only in a subset of children who received a three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ administered at approximately 4 years of age in all children who received a two catch-up doses of rMenB+OMV NZ as toddlers in study V72P12E1.
Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2 months apart to healthy naïve children at 4 years of age will be assessed.
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B+R246_18_48
Experimental
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B+R246_24_48
Experimental
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B246_12_48
Experimental
Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Biological
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.
The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
Day 1 (24-36 months post booster; baseline for naive)
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).
Day 1 (24-36 months post booster; baseline for naive)
Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.
Day 1 (24-36 months post booster dose; baseline for naive)
Secondary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A. Inclusion Criteria for naïve subjects, newly enrolled (B48_50):
4 years old (48 to 60 months) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. The age window is defined as the first day the subject turns 4 years old up to the day before the subject turns 5 years old.
For whom parent/legal guardian(s) has given written informed consent after the nature of the study has been explained.
For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in the study.
In good health as determined by medical history, physical examination, clinical judgment of the investigator.
Inclusion criteria are the same as for Group B48_50, with the addition that they are subjects who completed the vaccination course of V72P12E1 study.
Exclusion Criteria:
A. Exclusion Criteria for naïve subjects, newly enrolled (Group 7):
Subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study.
History of any meningococcal B vaccine administration.
Previous ascertained or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
History of allergic reaction to any vaccine component.
Significant chronic infection.
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
Known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants.
Participation in another clinical trial within 90 days prior to enrolment or planned for during study.
Family members and household members of research staff.
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Sadarangani M, Sell T, Iro MA, Snape MD, Voysey M, Finn A, Heath PT, Bona G, Esposito S, Diez-Domingo J, Prymula R, Odueyungbo A, Toneatto D, Pollard AJ; European MenB Vaccine Study Group. Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules. CMAJ. 2017 Oct 16;189(41):E1276-E1285. doi: 10.1503/cmaj.161288.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
All subjects were included in the trial.
Recruitment Details
Subjects were enrolled from 4 centers from the UK, 4 centers from Italy, 4 centers from Spain, 19 centers from Czech Republic.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-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: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B246_18_48
Experimental
Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B246_24_48
Experimental
Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B+R234_12_48
Experimental
Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B+R234_18_48
Experimental
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B+R234_24_48
Experimental
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B12 14_48
Experimental
Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 12 and14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B18 20_48
Experimental
Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B24 26_48
Experimental
Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B48_50
Experimental
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine, two months apart, in the present study.
Biological: 2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
B+R234_12_48
B+R234_18_48
B+R234_24_48
B+R246_12_48
B+R246_18_48
B+R246_24_48
B12 14_48
B18 20_48
B24 26_48
B246_12_48
B246_18_48
B246_24_48
rMenB+OMV NZ
2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Biological
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart
B48_50
rMenB+OMV NZ
Day 1 (22-34 months post last MenB vaccine)
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.
Day 1 (22-36 months post last MenB vaccine; baseline for naive)
GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.
Day 1 (22-34 months post last MenB vaccine)
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.
Day 31 (1 month post vaccination)
GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.
Day 31 (1 month post vaccination)
Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.
Day 31 (1 month post vaccination)
Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.
Day 31 (1 month post vaccination)
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
Day 31 (1 month post vaccination)
GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
Day 31 (1 month post vaccination)
GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.
The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.
Day 31 (1 month post vaccination)
Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine
The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.
Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.
Day 31 (1 month post vaccination)
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.
Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.
Immune sufficiency was not applicable for M10713 strain.
Day 91 (1 month post second vaccination)
GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.
Day 91 (1 month post second vaccination)
GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.
Day 91 (1 month post second vaccination)
Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.
Day 91 (1 month post second vaccination)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.
From day 1 to day 7 after vaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.
From day 1 to day 7 after vaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.
From day 1 to day 7 after any vaccination
Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.
From day 1 to study termination
Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
From day 1 to study termination
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela A Coruña
15706
Spain
Hospital Universitario Dr. Peset
Valencia
46017
Spain
Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir
Valencia
46020/46001
Spain
Complexo Hospitalario Xeral Cies
Vigo Pontevedra
36204
Spain
Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital
Oxford
Headington
OX3 7LJ
United Kingdom
North Bristol NHS Trust
Bristol
BS1 3NU
United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter
EX2 5DW
United Kingdom
St Georges Hospital
London
SW17 0RE
United Kingdom
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG002
B+R246_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG009
B12 14_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG010
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG011
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
FG012
B48_50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
FG00067 subjects
FG00161 subjects
FG00260 subjects
FG00366 subjects
FG00464 subjects
FG00555 subjects
FG00643 subjects
FG00729 subjects
FG00828 subjects
FG009100 subjects
FG01011 subjects
FG01112 subjects
FG012209 subjects
COMPLETED
FG00067 subjects
FG00160 subjects
FG00259 subjects
FG00366 subjects
FG00463 subjects
FG00554 subjects
FG00641 subjects
FG00728 subjects
FG00826 subjects
FG00999 subjects
FG01011 subjects
FG01112 subjects
FG012190 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0082 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG01219 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Father in hospital
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Anaysis was done on the all enrolled population, ie, all subjects who have signed an informed consent, undergone screening procedure(s) and were randomized.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG002
B+R246_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG009
B12 14_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG010
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG011
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
BG012
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00067
BG00161
BG00260
BG00366
BG00464
BG00555
BG00643
BG00729
BG00828
BG009100
BG01011
BG01112
BG012209
BG013805
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
Months
Title
Denominators
Categories
Title
Measurements
BG00051.8± 3.4
BG00152.1± 3.4
BG00251.7± 3.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
BG00128
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 Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.
The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 1 (24-36 months post booster; baseline for naive)
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B+R246_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Units
Counts
Participants
OG00067
OG00160
OG00260
OG003
Title
Denominators
Categories
H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206
Title
Measurements
OG00012(5 to 22)
OG00118(10 to 30)
OG00224(14 to 37)
Primary
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).
FAS, Persistency.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 (24-36 months post booster; baseline for naive)
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B+R246_24_48
Primary
Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.
FAS, Persistency.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 1 (24-36 months post booster dose; baseline for naive)
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B+R246_24_48
Secondary
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.
FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 1 (22-34 months post last MenB vaccine)
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B24 26_48
Secondary
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.
FAS, Persistency.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 (22-36 months post last MenB vaccine; baseline for naive)
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.
FAS, Persistency.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 1 (22-34 months post last MenB vaccine)
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.
Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 31 (1 month post vaccination)
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.
Analysis was done on FAS (Immunogenicity).
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 31 (1 month post vaccination)
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
Secondary
Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.
Analysis was done on FAS (Immunogenicity).
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 31 (1 month post vaccination)
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.
Analysis was done on FAS, Immunogenicity.
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 31 (1 month post vaccination)
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
Analysis was done on FAS (Immunogenicity).
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 31 (1 month post vaccination)
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
Analysis was done on FAS (Immunogenicity).
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 31 (1 month post vaccination)
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.
The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.
Analysis was done on FAS (Immunogenicity).
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 31 (1 month post vaccination)
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine
The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.
Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.
Analysis was done on FAS (Immunogenicity).
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 31 (1 month post vaccination)
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
Secondary
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.
Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.
Immune sufficiency was not applicable for M10713 strain.
Analysis was done on FAS (Immunogenicity).
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 91 (1 month post second vaccination)
ID
Title
Description
OG000
B48_50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG000
Secondary
GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.
Analysis was done on FAS (Immunogenicity).
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 91 (1 month post second vaccination)
ID
Title
Description
OG000
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG000175
Secondary
GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.
Analysis was done on FAS (Immunogenicity).
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 91 (1 month post second vaccination)
ID
Title
Description
OG000
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG000
Secondary
Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.
Analysis was done on FAS (Immunogenicity).
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 91 (1 month post second vaccination)
ID
Title
Description
OG000
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG000
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.
Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.
Posted
Number
Number of subjects
From day 1 to day 7 after vaccination
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.
Analysis was done on the safety population.
Posted
Number
Number of subjects
From day 1 to day 7 after vaccination
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.
Analysis was done on the safety population.
Posted
Number
Number of subjects
From day 1 to day 7 after any vaccination
ID
Title
Description
OG000
B48 50 (After 1st Dose)
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
OG001
B48 50 (After 2nd Dose)
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG000
Secondary
Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.
Analysis was done on the safety population.
Posted
Number
Number of subjects
From day 1 to study termination
ID
Title
Description
OG000
B+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B+R246_24_48
Secondary
Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
Analysis was done on the safety population.
Posted
Number
Number of subjects
From day 1 to study termination
ID
Title
Description
OG000
B12 14_48
Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG001
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG002
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Secondary
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
Analysis was done on the safety population.
Posted
Number
Number of participants
From day 1 to study termination
ID
Title
Description
OG000
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG000
Time Frame
Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Description
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246_12_48, B+R246_18_48, B+R246_24_48, B246_12_48, B246_18_48, B246_24_48 si referred to the subsect of subjects who actually received vaccination in the present study.
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+R246_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
30
29
30
EG001
B+R246_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
20
19
20
EG002
B+R246_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
17
17
17
EG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
19
18
19
EG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
27
25
27
EG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
17
17
17
EG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
43
42
43
EG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
29
28
29
EG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
28
27
28
EG009
B12 14_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
100
97
100
EG010
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
11
10
11
EG011
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
0
12
12
12
EG012
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
3
206
200
206
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CROUP INFECTIOUS
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG0030 affected19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
GASTROENTERITIS
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
CONCUSSION
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
PERIORBITAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG0031 affected19 at risk
EG0040 affected27 at risk
EG0051 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0091 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
INJECTION SITE ERYTHEMA
General disorders
MedDRA (16.1)
Systematic Assessment
EG00023 affected30 at risk
EG00113 affected20 at risk
EG00213 affected17 at risk
EG003
INJECTION SITE INDURATION
General disorders
MedDRA (16.1)
Systematic Assessment
EG00021 affected30 at risk
EG0018 affected20 at risk
EG00211 affected17 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA (16.1)
Systematic Assessment
EG00027 affected30 at risk
EG00119 affected20 at risk
EG00217 affected17 at risk
EG003
INJECTION SITE SWELLING
General disorders
MedDRA (16.1)
Systematic Assessment
EG00012 affected30 at risk
EG0017 affected20 at risk
EG00210 affected17 at risk
EG003
PYREXIA
General disorders
MedDRA (16.1)
Systematic Assessment
EG0007 affected30 at risk
EG0013 affected20 at risk
EG0023 affected17 at risk
EG003
ACUTE TONSILLITIS
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
ERYTHEMA INFECTIOSUM
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0021 affected17 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG00018 affected30 at risk
EG0017 affected20 at risk
EG0028 affected17 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0021 affected17 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected20 at risk
EG0020 affected17 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Systematic Assessment
EG00012 affected30 at risk
EG0014 affected20 at risk
EG0026 affected17 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (16.1)
Systematic Assessment
EG0005 affected30 at risk
EG0011 affected20 at risk
EG0026 affected17 at risk
EG003
EATING DISORDER
Psychiatric disorders
MedDRA (16.1)
Systematic Assessment
EG00012 affected30 at risk
EG0016 affected20 at risk
EG0026 affected17 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA (16.1)
Systematic Assessment
EG00018 affected30 at risk
EG0019 affected20 at risk
EG00211 affected17 at risk
EG003
CATARRH
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected20 at risk
EG0020 affected17 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com
ID
Term
D008589
Meningococcal Infections
D008585
Meningitis, Meningococcal
Ancestor Terms
ID
Term
D016870
Neisseriaceae Infections
D016905
Gram-Negative Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
D016920
Meningitis, Bacterial
D020806
Central Nervous System Bacterial Infections
D002494
Central Nervous System Infections
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D008581
Meningitis
D000090862
Neuroinflammatory Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
1 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
FG0082 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG01218 subjects
51.7
± 3.5
BG00451.3± 3.7
BG00552.3± 3.7
BG00651.8± 3.4
BG00751.4± 3.4
BG00853.1± 3.5
BG00951.7± 3.3
BG01053.4± 4.3
BG01156.8± 1.5
BG01253.7± 3.6
BG01352.4± 3.6
33
BG00328
BG00432
BG00530
BG00624
BG00717
BG00813
BG00950
BG0106
BG0114
BG01299
BG013387
Male
BG00044
BG00133
BG00227
BG00338
BG00432
BG00525
BG00619
BG00712
BG00815
BG00950
BG0105
BG0118
BG012110
BG013418
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG009
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
66
OG00463
OG00554
OG00642
OG00728
OG00828
OG009206
OG003
20
(11 to 32)
OG00427(17 to 40)
OG00535(23 to 49)
OG00612(4 to 26)
OG00725(11 to 45)
OG00821(8 to 41)
OG0090(0 to 3)
5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200
Title
Measurements
OG00093(83 to 98)
OG00198(91 to 100)
OG00297(88 to 100)
OG00397(89 to 100)
OG004100(94 to 100)
OG005100(93 to 100)
OG00690(77 to 97)
OG00789(72 to 98)
OG00896(82 to 100)
OG0095(2 to 8)
NZ 98/254 - ≥ 1:5
Title
Measurements
OG0009(3 to 18)
OG0018(3 to 18)
OG00212(5 to 23)
OG0039(3 to 19)
OG00411(5 to 22)
OG0059(3 to 20)
OG00610(3 to 23)
OG00711(2 to 28)
OG00811(2 to 28)
OG0090(0 to 3)
M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192
Title
Measurements
OG00054(41 to 66)
OG00168(54 to 79)
OG00274(61 to 85)
OG00355(42 to 68)
OG00453(40 to 66)
OG00580(66 to 89)
OG00668(51 to 81)
OG00775(55 to 89)
OG00875(55 to 89)
OG00960(53 to 67)
H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206
Title
Measurements
OG0007(2 to 17)
OG00110(4 to 21)
OG00217(8 to 29)
OG00311(4 to 21)
OG00424(14 to 36)
OG00528(16 to 42)
OG0067(1 to 19)
OG00721(8 to 41)
OG00821(8 to 41)
OG0090(0 to 3)
5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200
Title
Measurements
OG00091(82 to 97)
OG00197(88 to 100)
OG00293(83 to 98)
OG00394(85 to 98)
OG00494(84 to 98)
OG005100(93 to 100)
OG00690(77 to 97)
OG00786(67 to 96)
OG00896(82 to 100)
OG0093(1 to 6)
NZ 98/254 - ≥ 1:8
Title
Measurements
OG0004(1 to 13)
OG0015(1 to 14)
OG0028(3 to 18)
OG0038(3 to 17)
OG0043(0 to 11)
OG0054(0 to 13)
OG0062(0.06 to 13)
OG0077(1 to 24)
OG00811(2 to 28)
OG0090(0 to 3)
M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192
Title
Measurements
OG00049(37 to 62)
OG00153(39 to 66)
OG00260(47 to 73)
OG00348(35 to 61)
OG00445(32 to 58)
OG00565(51 to 77)
OG00660(43 to 75)
OG00761(41 to 78)
OG00861(41 to 78)
OG00956(48 to 63)
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG009
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG00067
OG00160
OG00260
OG00366
OG00463
OG00554
OG00642
OG00728
OG00828
OG009206
Title
Denominators
Categories
H44/76; N=67,60,59,65,63,54,42,28,28,206
Title
Measurements
OG0001.75(1.36 to 2.25)
OG0011.68(1.29 to 2.19)
OG0022.41(1.83 to 3.19)
OG0031.72(1.29 to 2.29)
OG0041.99(1.49 to 2.65)
OG0052.69(1.96 to 3.7)
OG0061.51(1.04 to 2.18)
OG0072.2(1.38 to 3.49)
OG0082.2(1.37 to 3.53)
OG0091.04(1.01 to 1.07)
5/99; N=67,60,58,64,62,54,42,28,28,200
Title
Measurements
OG00036(27 to 48)
OG00169(50 to 94)
OG00269(50 to 96)
OG003
NZ 98/254
Title
Measurements
OG0001.25(1.03 to 1.52)
OG0011.29(1.05 to 1.59)
OG0021.38(1.11 to 1.72)
OG003
M10713; N=65,59,58,62,60,54,40,28,28,192
Title
Measurements
OG0006.14(4.19 to 8.99)
OG0017.36(4.94 to 11)
OG0029.08(5.97 to 14)
OG003
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Units
Counts
Participants
OG00063
OG00157
OG00254
OG00359
OG00456
OG00547
OG00639
OG00728
OG00825
Title
Denominators
Categories
H44/76; N=62,56,52,57,55,46,38,27,25,206
Title
Measurements
OG0000.012(0.0091 to 0.017)
OG0010.013(0.0096 to 0.018)
OG0020.023(0.016 to 0.033)
OG0030.0092(0.0066 to 0.013)
OG0040.013(0.0097 to 0.018)
OG0050.023(0.016 to 0.033)
OG0060.0091(0.0064 to 0.013)
OG0070.023(0.015 to 0.036)
OG0080.023(0.014 to 0.036)
5/99; N=61,57,50,57,55,44,37,27,25,200
Title
Measurements
OG0000.029(0.023 to 0.037)
OG0010.032(0.026 to 0.041)
OG0020.043(0.033 to 0.056)
OG003
NZ 98/254
Title
Measurements
OG0000.028(0.021 to 0.039)
OG0010.094(0.067 to 0.13)
OG0020.071(0.05 to 0.1)
OG003
M10713; N=26,24,25
Title
Measurements
OG000NA(NA to NA)GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
OG001NA(NA to NA)GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
OG002NA(NA to NA)GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG00096
OG00111
OG00211
OG003206
Title
Denominators
Categories
hSBA≥ 1:5 (H44/76 strain)
Title
Measurements
OG00011(6 to 20)
OG0019(0 to 41)
OG0029(0 to 41)
OG0030(0 to 3)
hSBA≥ 1:5 (5/99 strain; N=96,11,11,200)
Title
Measurements
OG00084(76 to 91)
OG001100(72 to 100)
OG002100(72 to 100)
OG003
hSBA≥ 1:5 (NZ 98/254 strain)
Title
Measurements
OG0003(1 to 9)
OG00118(2 to 52)
OG0020(0 to 28)
OG003
hSBA≥ 1:5 (M10713 strain; N=96,10,10,192)
Title
Measurements
OG00059(49 to 69)
OG00160(26 to 88)
OG00260(26 to 88)
OG003
hSBA≥ 1:8 (H44/76 strain)
Title
Measurements
OG0008(4 to 16)
OG0019(0 to 41)
OG0020(0 to 28)
OG003
hSBA≥ 1:8 (5/99 strain; N=96,11,11,200)
Title
Measurements
OG00081(72 to 88)
OG001100(72 to 100)
OG002100(72 to 100)
OG003
hSBA≥ 1:8 (NZ 98/254 strain)
Title
Measurements
OG0002(0 to 7)
OG00118(2 to 52)
OG0020(0 to 28)
OG003
hSBA≥ 1:8 (M10713 strain; N=96,10,10,192)
Title
Measurements
OG00049(39 to 59)
OG00140(12 to 74)
OG00260(26 to 88)
OG003
OG003
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG00096
OG00111
OG00211
OG003206
Title
Denominators
Categories
H44/76 strain
Title
Measurements
OG0001.61(1.3 to 2)
OG0012.03(1.11 to 3.72)
OG0021.69(0.91 to 3.12)
OG0031.04(1.01 to 1.07)
5/99 strain; N=96, 11, 11, 200
Title
Measurements
OG00023(17 to 32)
OG00147(20 to 112)
OG00269(29 to 165)
OG003
NZ 98/254 strain
Title
Measurements
OG0001.15(0.96 to 1.37)
OG0012.68(1.65 to 4.36)
OG0021.06(0.65 to 1.75)
OG003
M10713 strain; N=96, 10, 10, 192
Title
Measurements
OG0007.83(5.54 to 11)
OG0019.67(3.54 to 26)
OG0028.4(3.03 to 23)
OG003
Units
Counts
Participants
OG00088
OG0019
OG00210
Title
Denominators
Categories
H44/76 strain
Title
Measurements
OG0000.092(0.069 to 0.12)
OG0010.18(0.078 to 0.43)
OG0020.2(0.086 to 0.45)
5/99 strain
Title
Measurements
OG0000.45(0.34 to 0.59)
OG0011.9(0.84 to 4.29)
OG0021.36(0.62 to 3)
NZ 98/254 strain; N=88, 9, 8
Title
Measurements
OG0000.28(0.21 to 0.37)
OG0010.73(0.32 to 1.68)
OG0020.42(0.17 to 1.01)
M10713 strain; N=7, 7, 8
Title
Measurements
OG00011(3.34 to 38)
OG0016.05(1.45 to 25)
OG0026.88(1.68 to 28)
OG002
B+R246_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG009
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG009
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG009
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG009
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG00097
OG00110
OG00212
OG003175
Title
Denominators
Categories
hSBA≥ 1:5 (H44/76 strain)
Title
Measurements
OG000100(96 to 100)
OG001100(69 to 100)
OG002100(74 to 100)
OG00371(64 to 78)
hSBA≥ 1:5 (5/99 strain; N=95,10,12,171)
Title
Measurements
OG000100(96 to 100)
OG001100(69 to 100)
OG002100(74 to 100)
OG003
hSBA≥ 1:5 (NZ 98/254 strain; N=95,10,12,173)
Title
Measurements
OG00096(90 to 99)
OG00170(35 to 93)
OG002100(74 to 100)
OG003
hSBA≥ 1:5 (M10713 strain; N=90,9,10,167)
Title
Measurements
OG00093(86 to 98)
OG001100(66 to 100)
OG00290(55 to 100)
OG003
hSBA≥ 1:8 (H44/76 strain)
Title
Measurements
OG000100(96 to 100)
OG001100(69 to 100)
OG002100(74 to 100)
OG003
hSBA≥ 1:8 (5/99 strain; N=94,10,12,171)
Title
Measurements
OG000100(96 to 100)
OG001100(69 to 100)
OG002100(74 to 100)
OG003
hSBA≥ 1:8 (NZ 98/254 strain; N=95,10,12,173)
Title
Measurements
OG00095(88 to 98)
OG00160(26 to 88)
OG002100(74 to 100)
OG003
hSBA≥ 1:8 (M10713 strain; N=90,9,10,167)
Title
Measurements
OG00092(85 to 97)
OG001100(66 to 100)
OG00290(55 to 100)
OG003
OG003
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG00097
OG00110
OG00212
OG003183
Title
Denominators
Categories
H44/76 strain
Title
Measurements
OG000154(124 to 191)
OG001145(76 to 277)
OG002211(116 to 383)
OG00311(8.51 to 14)
5/99 strain; N= 94,10,12,171
Title
Measurements
OG0001575(1219 to 2034)
OG0012381(1112 to 5095)
OG0023604(1785 to 7278)
OG003
NZ 98/254 strain; N=95,10,12,173
Title
Measurements
OG00031(25 to 39)
OG00118(8.87 to 35)
OG00247(25 to 88)
OG003
M10713 strain; N=90,9,10,167
Title
Measurements
OG00038(29 to 49)
OG00174(34 to 164)
OG00284(39 to 180)
OG003
OG003
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG00097
OG00110
OG00211
OG003175
Title
Denominators
Categories
H44/76 strain
Title
Measurements
OG00099(79 to 125)
OG00167(34 to 135)
OG002133(68 to 258)
OG00310(8.2 to 13)
5/99 strain; N=92,10,11,168
Title
Measurements
OG00070(57 to 86)
OG00151(27 to 95)
OG00255(30 to 99)
OG003
NZ 98/254 strain; N=93,10,11,173
Title
Measurements
OG00027(21 to 36)
OG0015.96(2.7 to 13)
OG00238(18 to 81)
OG003
M10713 strain; N=88,9,9,158
Title
Measurements
OG0005.24(3.91 to 7.02)
OG0017.06(2.92 to 17)
OG0027.35(3.03 to 18)
OG003
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Units
Counts
Participants
OG00095
OG00110
OG00211
OG003175
Title
Denominators
Categories
H44/76 strain
Title
Measurements
OG00099(94 to 100)
OG00190(55 to 100)
OG002100(72 to 100)
OG00363(55 to 70)
5/99 strain; N=92,10,11,168
Title
Measurements
OG000100(96 to 100)
OG00190(55 to 100)
OG002100(72 to 100)
OG003
NZ 98/254 strain; N=93,10,11,173
Title
Measurements
OG00094(86 to 98)
OG00150(19 to 81)
OG002100(72 to 100)
OG003
M10713 strain; N=88,9,9,158
Title
Measurements
OG00058(47 to 68)
OG00167(30 to 93)
OG00256(21 to 86)
OG003
175
Title
Denominators
Categories
hSBA≥ 1:5 (H44/76 strain)
Title
Measurements
OG000100(98 to 100)
hSBA≥ 1:5 (5/99 strain)
Title
Measurements
OG000100(98 to 100)
hSBA≥ 1:5 (NZ 98/254 strain; N=174)
Title
Measurements
OG00091(85 to 95)
hSBA≥ 1:8 (H44/76 strain)
Title
Measurements
OG000100(98 to 100)
hSBA≥ 1:8 (5/99 strain)
Title
Measurements
OG000100(98 to 100)
hSBA≥ 1:8 (NZ 98/254 strain; N=174)
Title
Measurements
OG00080(73 to 86)
Title
Denominators
Categories
H44/76 strain
Title
Measurements
OG000109(98 to 120)
5/99 strain
Title
Measurements
OG000343(302 to 389)
NZ 98/254 strain; N=174
Title
Measurements
OG00017(14 to 19)
M10713 strain; N=171
Title
Measurements
OG00047(40 to 56)
175
Title
Denominators
Categories
H44/76 strain
Title
Measurements
OG000105(94 to 116)
5/99 strain; N=172
Title
Measurements
OG000299(256 to 350)
NZ 98/254 strain; N=174
Title
Measurements
OG00017(14 to 19)
M10713 strain; N=171
Title
Measurements
OG0005.12(3.95 to 6.65)
175
Title
Denominators
Categories
H44/76 strain
Title
Measurements
OG000100(98 to 100)
5/99 strain; N=172
Title
Measurements
OG00099(97 to 100)
NZ 98/254 strain; N=174
Title
Measurements
OG00080(73 to 86)
M10713 strain; N=161
Title
Measurements
OG00051(43 to 59)
OG002
B+R246_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Units
Counts
Participants
OG00029
OG00120
OG00217
OG00319
OG00427
OG00517
OG00643
OG00729
OG00827
Title
Denominators
Categories
Any local
Title
Measurements
OG00027
OG00118
OG00217
OG00316
OG00424
OG00517
OG00638
OG00728
OG00827
Injection site Pain (mild)
Title
Measurements
OG0004
OG0015
OG0021
OG003
Injection site Pain (moderate)
Title
Measurements
OG00018
OG0019
OG00213
OG003
Injection site Pain (severe)
Title
Measurements
OG0005
OG0014
OG0023
OG003
Injection site Erythema (25 - 50 mm)
Title
Measurements
OG0002
OG0013
OG0023
OG003
Injection site Erythema (51 - 100 mm)
Title
Measurements
OG0005
OG0012
OG0021
OG003
Injection site Erythema (>100 mm)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Injection site Induration (25 - 50 mm)
Title
Measurements
OG0002
OG0012
OG0021
OG003
Injection site Induration (51 - 100 mm)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Injection site Induration (>100 mm)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Injection site Swelling (25 - 50 mm)
Title
Measurements
OG0001
OG0013
OG0023
OG003
Injection site Swelling (51 - 100 mm)
Title
Measurements
OG0001
OG0010
OG0021
OG003
Injection site Swelling (>100 mm)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Any Systemic
Title
Measurements
OG00026
OG00115
OG00214
OG003
Change in eating habits
Title
Measurements
OG00012
OG0016
OG0026
OG003
Rash
Title
Measurements
OG0002
OG0011
OG0020
OG003
Arthralagia
Title
Measurements
OG00012
OG0014
OG0026
OG003
Headache
Title
Measurements
OG0005
OG0011
OG0026
OG003
Irritability
Title
Measurements
OG00018
OG0019
OG00211
OG003
Diarrhea
Title
Measurements
OG0004
OG0011
OG0021
OG003
Vomiting
Title
Measurements
OG0000
OG0011
OG0020
OG003
Fever (≥ 38.0 °C)
Title
Measurements
OG0006
OG0013
OG0023
OG003
Antipyretic used (prophylactically)
Title
Measurements
OG0001
OG0012
OG0021
OG003
Antipyretic used (therapeutically)
Title
Measurements
OG0005
OG0015
OG0024
OG003
Units
Counts
Participants
OG00099
OG00110
OG00212
Title
Denominators
Categories
Any local
Title
Measurements
OG00094
OG0019
OG00211
Injection site Pain (mild)
Title
Measurements
OG00033
OG0012
OG0022
Injection site Pain (moderate)
Title
Measurements
OG00042
OG0016
OG0028
Injection site Pain (severe)
Title
Measurements
OG00019
OG0011
OG0021
Injection site Erythema (25 - 50 mm)
Title
Measurements
OG00012
OG0012
OG0020
Injection site Erythema (51 - 100 mm)
Title
Measurements
OG0007
OG0011
OG0020
Injection site Erythema (>100 mm)
Title
Measurements
OG0002
OG0010
OG0020
Injection site Induration (25 - 50 mm)
Title
Measurements
OG0008
OG0011
OG0020
Injection site Induration (51 - 100 mm)
Title
Measurements
OG0000
OG0010
OG0020
Injection site Induration (>100 mm)
Title
Measurements
OG0001
OG0010
OG0020
Injection site Swelling (25 - 50 mm)
Title
Measurements
OG00018
OG0012
OG0023
Injection site Swelling (51 - 100 mm)
Title
Measurements
OG0002
OG0010
OG0021
Injection site Swelling (>100 mm)
Title
Measurements
OG0000
OG0010
OG0020
Any Systemic
Title
Measurements
OG00078
OG0016
OG0029
Change in eating habits
Title
Measurements
OG00042
OG0010
OG0023
Rash
Title
Measurements
OG00013
OG0010
OG0020
Arthralagia
Title
Measurements
OG00028
OG0011
OG0026
Headache
Title
Measurements
OG00020
OG0012
OG0024
Irritability
Title
Measurements
OG00053
OG0014
OG0025
Diarrhea
Title
Measurements
OG0005
OG0010
OG0022
Vomiting
Title
Measurements
OG0006
OG0012
OG0021
Fever (≥ 38.0 °C)
Title
Measurements
OG00016
OG0014
OG0025
Antipyretic used (prophylactically)
Title
Measurements
OG0005
OG0012
OG0022
Antipyretic used (therapeutically)
Title
Measurements
OG00018
OG0014
OG0025
205
OG001194
Title
Denominators
Categories
Any local
Title
Measurements
OG000186
OG001161
Injection site Pain (mild)
Title
Measurements
OG00081
OG00170
Injection site Pain (moderate)
Title
Measurements
OG00077
OG00166
Injection site Pain (severe)
Title
Measurements
OG00027
OG00121
Injection site Erythema (25 - 50 mm; N= 204, 194)
Title
Measurements
OG00034
OG00115
Injection site Erythema (51 - 100 mm; N= 204, 194)
Title
Measurements
OG0008
OG00119
Injection site Erythema (>100 mm; N= 204, 194)
Title
Measurements
OG0001
OG0010
Injection site Induration (25 - 50 mm; N= 204, 194
Title
Measurements
OG00023
OG00116
Injection site Induration (51-100 mm; N= 204, 194)
Title
Measurements
OG0003
OG0014
Injection site Induration(>100 mm; N= 204, 194
Title
Measurements
OG0000
OG0010
Injection site Swelling (25 - 50 mm; N= 204, 194
Title
Measurements
OG00026
OG00120
Injection site Swelling (51 - 100 mm; N= 204, 194)
Title
Measurements
OG0003
OG0014
Injection site Swelling (>100 mm; N= 204, 194)
Title
Measurements
OG0001
OG0010
Any Systemic
Title
Measurements
OG000137
OG001108
Rash; N=201, 192
Title
Measurements
OG00015
OG00110
Change in eating habits; N= 203, 194
Title
Measurements
OG00049
OG00143
Headache; N= 204, 194
Title
Measurements
OG00025
OG00124
Arthralagia; N= 203, 192
Title
Measurements
OG00045
OG00140
Irritability; N= 204, 193
Title
Measurements
OG00067
OG00158
Vomiting
Title
Measurements
OG0008
OG0016
Diarrhea; N= 204, 193
Title
Measurements
OG00011
OG0018
Fever (≥ 38.0 °C; N= 204, 189)
Title
Measurements
OG00020
OG00116
Antipyretic used (prophylactically; N= 204, 193)
Title
Measurements
OG00017
OG00123
Antipyretic used (therapeutically; N= 204, 193)
Title
Measurements
OG00022
OG00124
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG003
B246_12_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG004
B246_18_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG005
B246_24_48
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG006
B+R234_12_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG007
B+R234_18_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
OG008
B+R234_24_48
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Units
Counts
Participants
OG00030
OG00120
OG00217
OG00319
OG00427
OG00517
OG00643
OG00729
OG00828
Title
Denominators
Categories
Any AEs
Title
Measurements
OG0008
OG0014
OG0024
OG0037
OG0047
OG0053
OG00611
OG00711
OG0086
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
AEs leading to withdrawal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Units
Counts
Participants
OG000100
OG00111
OG00212
Title
Denominators
Categories
Any AE
Title
Measurements
OG00025
OG0012
OG0024
SAEs
Title
Measurements
OG0000
OG0010
OG0020
AEs leading to withdrawal
Title
Measurements
OG0000
OG0010
OG0020
206
Title
Denominators
Categories
Any AEs
Title
Measurements
OG000105
SAEs
Title
Measurements
OG0003
AEs leading to premature withdrawal
Title
Measurements
OG0001
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
16 affected
19 at risk
EG00421 affected27 at risk
EG00514 affected17 at risk
EG00638 affected43 at risk
EG00724 affected29 at risk
EG00823 affected28 at risk
EG00973 affected100 at risk
EG0108 affected11 at risk
EG0117 affected12 at risk
EG012166 affected206 at risk
14 affected
19 at risk
EG00411 affected27 at risk
EG00512 affected17 at risk
EG00624 affected43 at risk
EG00721 affected29 at risk
EG00819 affected28 at risk
EG00946 affected100 at risk
EG0106 affected11 at risk
EG0114 affected12 at risk
EG012117 affected206 at risk
16 affected
19 at risk
EG00423 affected27 at risk
EG00516 affected17 at risk
EG00638 affected43 at risk
EG00728 affected29 at risk
EG00827 affected28 at risk
EG00994 affected100 at risk
EG0109 affected11 at risk
EG01111 affected12 at risk
EG012192 affected206 at risk
13 affected
19 at risk
EG00410 affected27 at risk
EG00511 affected17 at risk
EG00625 affected43 at risk
EG00717 affected29 at risk
EG00814 affected28 at risk
EG00946 affected100 at risk
EG0106 affected11 at risk
EG0117 affected12 at risk
EG01296 affected206 at risk
2 affected
19 at risk
EG0041 affected27 at risk
EG0051 affected17 at risk
EG0067 affected43 at risk
EG0074 affected29 at risk
EG0082 affected28 at risk
EG00919 affected100 at risk
EG0105 affected11 at risk
EG0115 affected12 at risk
EG01236 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0072 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0051 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0081 affected28 at risk
EG0093 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0126 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0081 affected28 at risk
EG0090 affected100 at risk
EG0101 affected11 at risk
EG0110 affected12 at risk
EG0122 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0051 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0101 affected11 at risk
EG0111 affected12 at risk
EG0123 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0081 affected28 at risk
EG0091 affected100 at risk
EG0100 affected11 at risk
EG0111 affected12 at risk
EG0123 affected206 at risk
9 affected
19 at risk
EG00412 affected27 at risk
EG0056 affected17 at risk
EG00622 affected43 at risk
EG00721 affected29 at risk
EG00814 affected28 at risk
EG00952 affected100 at risk
EG0103 affected11 at risk
EG0113 affected12 at risk
EG012105 affected206 at risk
2 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0061 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0091 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG01211 affected206 at risk
1 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0061 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0120 affected206 at risk
1 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0121 affected206 at risk
1 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG0120 affected206 at risk
5 affected
19 at risk
EG0042 affected27 at risk
EG0054 affected17 at risk
EG0067 affected43 at risk
EG0075 affected29 at risk
EG0082 affected28 at risk
EG00913 affected100 at risk
EG0100 affected11 at risk
EG0110 affected12 at risk
EG01224 affected206 at risk
9 affected
19 at risk
EG0048 affected27 at risk
EG0055 affected17 at risk
EG00611 affected43 at risk
EG0078 affected29 at risk
EG00812 affected28 at risk
EG00928 affected100 at risk
EG0101 affected11 at risk
EG0116 affected12 at risk
EG01267 affected206 at risk
3 affected
19 at risk
EG0042 affected27 at risk
EG0053 affected17 at risk
EG0067 affected43 at risk
EG0075 affected29 at risk
EG0088 affected28 at risk
EG00920 affected100 at risk
EG0102 affected11 at risk
EG0114 affected12 at risk
EG01240 affected206 at risk
12 affected
19 at risk
EG0047 affected27 at risk
EG0058 affected17 at risk
EG00620 affected43 at risk
EG00711 affected29 at risk
EG00813 affected28 at risk
EG00942 affected100 at risk
EG0100 affected11 at risk
EG0113 affected12 at risk
EG01275 affected206 at risk
14 affected
19 at risk
EG00413 affected27 at risk
EG0058 affected17 at risk
EG00623 affected43 at risk
EG00720 affected29 at risk
EG00816 affected28 at risk
EG00953 affected100 at risk
EG0104 affected11 at risk
EG0115 affected12 at risk
EG01291 affected206 at risk
0 affected
19 at risk
EG0040 affected27 at risk
EG0050 affected17 at risk
EG0060 affected43 at risk
EG0070 affected29 at risk
EG0080 affected28 at risk
EG0090 affected100 at risk
EG0101 affected11 at risk
EG0110 affected12 at risk
EG0120 affected206 at risk
59
(45 to 78)
OG00457(43 to 75)
OG005111(82 to 151)
OG00652(34 to 81)
OG00762(36 to 108)
OG008101(57 to 177)
OG0091.15(1.05 to 1.27)
1.48
(1.2 to 1.83)
OG0041.34(1.08 to 1.66)
OG0051.52(1.2 to 1.92)
OG0061.32(1.05 to 1.65)
OG0071.25(0.94 to 1.66)
OG0081.62(1.21 to 2.16)
OG0091.01(0.99 to 1.03)
7.86
(5.17 to 12)
OG0047.77(5.07 to 12)
OG00515(9.49 to 24)
OG0069.61(5.81 to 16)
OG00711(5.92 to 20)
OG00811(5.9 to 21)
OG0098.75(6.74 to 11)
0.031
(0.024 to 0.041)
OG0040.034(0.026 to 0.045)
OG0050.054(0.04 to 0.074)
OG0060.035(0.026 to 0.048)
OG0070.037(0.025 to 0.054)
OG0080.055(0.037 to 0.081)
0.043
(0.031 to 0.06)
OG0040.081(0.058 to 0.11)
OG0050.11(0.075 to 0.16)
OG0060.03(0.02 to 0.044)
OG0070.082(0.05 to 0.14)
OG0080.066(0.038 to 0.11)
OG003NA(NA to NA)GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
OG004NA(NA to NA)GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
OG005NA(NA to NA)GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.