Safety, Tolerability and Immunogenicity of Meningococcal... | NCT00944034 | Trialant
NCT00944034
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Aug 14, 2017Actual
Enrollment
1,588Actual
Phase
Phase 2Phase 3
Conditions
Meningococcal Disease
Meningococcal Meningitis
Interventions
rMenB+OMV NZ with routine vaccinations
rMenB+OMV NZ with routine vaccinations
rMenB+OMV NZ
rMenB+OMV NZ
rMenB+OMV NZ with routine vaccinations
rMenB+OMV NZ with routine vaccinations
two doses of rMenB+OMV NZ
rMenB+OMV NZ with routine vaccinations
two doses of rMenB+OMV NZ
rMenB+OMV NZ
two doses of rMenB+OMV NZ
rMenB+OMV NZ with routine vaccinations
Countries
Belgium
Czechia
Germany
Italy
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00944034
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V72P12E1
Secondary IDs
ID
Type
Description
Link
2009-011676-30
Brief Title
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
Official Title
A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jul 2017
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
Jul 2009
Primary Completion Date
Aug 2011Actual
Completion Date
Jan 2012Actual
First Submitted Date
Jul 21, 2009
First Submission Date that Met QC Criteria
Jul 21, 2009
First Posted Date
Jul 22, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 16, 2015
Results First Submitted that Met QC Criteria
Oct 7, 2015
Results First Posted Date
Nov 10, 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
Jul 12, 2017
Last Update Posted Date
Aug 14, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.
Detailed Description
Not provided
Conditions Module
Conditions
Meningococcal Disease
Meningococcal Meningitis
Keywords
Meningococcal meningitis
prevention
vaccination
toddler
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,588Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
B+R246_12
Experimental
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.
Biological: rMenB+OMV NZ with routine vaccinations
B+R246_18
Experimental
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.
Biological: rMenB+OMV NZ with routine vaccinations
B+R246_24
Experimental
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.
Biological: rMenB+OMV NZ with routine vaccinations
B246_12
Experimental
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.
Biological: rMenB+OMV NZ
B246_18
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
rMenB+OMV NZ with routine vaccinations
Biological
rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.
1 month after booster
Secondary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.
Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Follow-on participants of V72P12:
Healthy toddlers who completed Study V72P12, aged:
12 months or older - Groups 1a, 2a, 3a, 4
18 months (0/ +29 days window) - Groups 1b, 2b, 3b
24 months (0/ +29 days window) - Groups 1c, 2c, 3c
Naive subjects newly enrolled:
Group 5: healthy 18-month-old toddlers (0/ +29 days window)
Group 6: healthy 24-month-old toddlers (0/ +29 days window)
Exclusion Criteria:
History of any meningococcal B vaccine administration (only for groups 5 and 6);
Previous ascertained or suspected disease caused by N. meningitidis;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to 38 degrees within the previous day
Antibiotics within 6 days prior to enrollment;
Any serious chronic or progressive disease;
Known or suspected impairment or alteration of the immune system;
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.
Subjects were enrolled from 6 centres in Belgium, 4 in Czech, 24 in Germany, 5 in Italy, 16 in Spain and 4 in UK who had previously participated in and completed the study V72P12.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
B+R246_12
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.age
FG001
B+R246_18
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: rMenB+OMV NZ
B246_24
Experimental
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.
Biological: rMenB+OMV NZ
B+R234_12
Experimental
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 12 months of age.
Biological: rMenB+OMV NZ with routine vaccinations
B+R234_18
Experimental
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 18 months of age.
Biological: rMenB+OMV NZ with routine vaccinations
B+R234_24
Experimental
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.
Biological: rMenB+OMV NZ with routine vaccinations
B12 14
Experimental
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
Biological: two doses of rMenB+OMV NZ
B18 20
Experimental
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
Biological: two doses of rMenB+OMV NZ
B24 26
Experimental
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Biological: two doses of rMenB+OMV NZ
B+R246_12
rMenB+OMV NZ with routine vaccinations
Biological
rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
B+R246_18
rMenB+OMV NZ
Biological
rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
B246_12
rMenB+OMV NZ
Biological
rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
B246_18
rMenB+OMV NZ with routine vaccinations
Biological
rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age
B+R234_12
rMenB+OMV NZ with routine vaccinations
Biological
rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age
B+R234_18
two doses of rMenB+OMV NZ
Biological
two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.
B12 14
rMenB+OMV NZ with routine vaccinations
Biological
rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
B+R246_24
two doses of rMenB+OMV NZ
Biological
two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age
B18 20
rMenB+OMV NZ
Biological
rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
B246_24
two doses of rMenB+OMV NZ
Biological
two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age
B24 26
rMenB+OMV NZ with routine vaccinations
Biological
rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age
B+R234_24
1 month after booster
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.
1 month after booster
Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.
The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
1 month after booster
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
1 month after booster
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
1 month after booster
Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months
Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
1 month after second vaccination
Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.
Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.
1 month after booster vaccination
Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.
Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA
1 month after booster vaccination
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
From day 1 to day 7 after vaccination
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
day 1 to day 7 after vaccination
Avenue Hippocrate 10, 1200 Brussels
Belgium
Laarbeeklaan 101, 1090 Brussels
Belgium
Lindendreef 1, 2020 Antwerpen
Belgium
Sint Vincentiusstraat 20, 2018 Antwerpen
Belgium
Stadsomvaart 11, 3500 Hasselt
Belgium
Wilrijkstraat 10, 2650 Edegem
Belgium
Červený Kostelec
549 41
Czechia
Kyjevska 44, 532 03 Pardubice
Czechia
Ruskych Legii 352, 377 01 Jindrichuv Hradec
Czechia
Trebesska 1575, 500 01 Hradec Kralove
Czechia
Ahrensböker Str. 11, 23617 Stockelsdorf
Germany
Am Alten Hafen 117, 27568 Bremerhaven
Germany
Ammertalweg 7, 99086 Erfurt
Germany
Anne Frank Str.27, 75015 Bretten
Germany
Bucher Chaussee 1-3, 13125 Berlin
Germany
Christian-Bauer-Str.5, 73642 Welzheim
Germany
Deckertstr. 53, 33645 Bielefeld
Germany
Dingbängerweg 69, 48163 Münster
Germany
Elisenstr. 28, 63739 Aschaffenburg
Germany
Gartenstr. 3,76889 Schweigen
Germany
Großbottwarer Str. 47, 71720 Oberstenfeld
Germany
Hanseatenplatz 1, 25524 Itzehoe
Germany
Hauptstr. 165, 42579 Heiligenhaus
Germany
Hauptstr. 240, 77694 Kehl
Germany
Hauptstr. 46, 37083 Göttingen
Germany
Josef-Sugg-Str. 5, 88348 Bad Saulgau
Germany
Kapellenstraße 27, 47533 Kleve-Materborn
Germany
Kleinenbroicher Str. 68, 41352 Korschenbroich
Germany
Kuhtrift 8a, 34414 Warburg
Germany
Langenbeckstraße 1, 55101 Mainz
Germany
Lindenpromenade 34b, 39164 Wanzleben
Germany
Lindenstr. 9, 25524 Itzehoe
Germany
Marienstraße 2, 44866 Bochum
Germany
Maschstr. 8a, 49565 Bramsche
Germany
Mose-Stern-Str. 28, 41236 Mönchengladbach
Germany
Ostlandstr. 10, 32339 Espelkamp
Germany
Poststr. 10, 34225 Baunatal
Germany
Tangstedter Landstr 77, 22415 Hamburg
Germany
Wilhelmshöher Allee 109, 34121 Kassel
Germany
Würzburger Str. 1, 97941 Tauberbischofsheim
Germany
C.so Mazzini 18, 28100 Novar
Italy
Current Address: Via Luca Giordano N. 13, 50132 Firenze
Italy
Piazza Ospedale 10, 20900 Lodi
Italy
Via Commenda 9, 20122, Milano
Italy
Via Consolare Valeria 1, 98125 Messina
Italy
Via G.B.Grossi 74, 20157 Milano
Italy
Via Giustiniani,3, 35128 Padova
Italy
Via Pastore 1,16132 Genova
Italy
Via Siracusa, 45, 90143 Palermo
Italy
Viale Pieraccini N. 24 50139 Firenze
Italy
Avda. Rambleta, S/n Catarroja Valencia
Spain
C/ Tossal Del Rei Nº 7 Castellón de La Plana Castellón
Spain
Catarroja Esquina Ministro Serrano. Paiporta Valencia
TravesÃa Da Choupana, S/n Santiago de Compostela A Coruña
Spain
University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
United Kingdom
South West Medicines for Children Research Network, Child Health Building, Royal Devon and Exeter NHS Foundation Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom
St. George's University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
Oxford Vaccines Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Centre for Clinical Vaccinology
Oxford
OX3 7LJ
United Kingdom
Derived
Snape MD, Voysey M, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Kieninger D, Prymula R, Dull PM, Kohl I, Barone M, Wang H, Toneatto D, Pollard AJ; European MenB Vaccine Study Group. Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. Pediatr Infect Dis J. 2016 Apr;35(4):e113-23. doi: 10.1097/INF.0000000000001056.
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.
FG002
B+R246_24
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.
FG003
B246_12
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.
FG004
B246_18
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.
FG005
B246_24
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.
FG006
B+R234_12
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 12 months of age.
FG007
B+R234_18
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 18 months of age.
FG008
B+R234_24
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.
FG009
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
FG010
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
FG011
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
FG000188 subjects
FG001157 subjects
FG002152 subjects
FG003174 subjects
FG004164 subjects
FG005143 subjects
FG006106 subjects
FG00778 subjects
FG00873 subjects
FG009246 subjects
FG01051 subjects
FG01156 subjects
COMPLETED
FG000183 subjects
FG001150 subjects
FG002143 subjects
FG003170 subjects
FG004150 subjects
FG005123 subjects
FG006102 subjects
FG00773 subjects
FG00863 subjects
FG009236 subjects
FG01050 subjects
FG01152 subjects
NOT COMPLETED
FG0005 subjects
FG0017 subjects
FG0029 subjects
FG0034 subjects
FG00414 subjects
FG00520 subjects
FG0064 subjects
FG0075 subjects
FG00810 subjects
FG00910 subjects
FG0101 subjects
FG0114 subjects
Type
Comment
Reasons
Inappropriate enrollment
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Withdrawal by Subject
FG0003 subjects
FG0012 subjects
FG0026 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0014 subjects
FG0022 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Unable to classify
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Administrative reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
B+R246_12
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.
BG001
B+R246_18
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.
BG002
B+R246_24
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.
BG003
B246_12
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.
BG004
B246_18
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.
BG005
B246_24
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.
BG006
B+R234_12
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 12 months of age.
BG007
B+R234_18
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 18 months of age.
BG008
B+R234_24
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.
BG009
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
BG010
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
BG011
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000188
BG001157
BG002152
BG003174
BG004164
BG005143
BG006106
BG00778
BG00873
BG009246
BG01051
BG01156
BG0121588
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG000188
BG001157
BG002152
BG003
Age, Continuous
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG00012.6± 1.2
BG00118.1± 0.6
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00078
BG00173
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.
The analysis was performed on the per-protocol population. This outcome measure was assessed only for the strains H44/76, NZ98/254 and 5/99. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.
Posted
Number
98.3% Confidence Interval
percentage of subjects
1 month after booster
ID
Title
Description
OG000
B+R246_12
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.
OG001
B+R246_18
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.
OG002
B+R246_24
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.
Units
Counts
Participants
OG000162
OG001120
OG002108
Title
Denominators
Categories
hSBA≥ 1: 5 (H44/76 strain)(N = 158,116,101)
Title
Measurements
OG00097(93 to 99)
OG001100(96 to 100)
OG002100(95 to 100)
hSBA≥ 1: 5 (5/99 strain)(N= 156,118,100)
Secondary
Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.
Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.
The analysis was performed on per-protocol population. This outcome measure was assessed only against H44/76, NZ98/254 and 5/99 strains. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.
Posted
Number
98.3% Confidence Interval
percentage of subjects
1 month after booster
ID
Title
Description
OG000
B246_12
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.
OG001
B246_18
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.
OG002
Secondary
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.
The analysis was performed on the per-protocol population
Posted
Number
95% Confidence Interval
percentage of subjects
1 month after booster
ID
Title
Description
OG000
B+R234_12
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 12 months of age.
OG001
B+R234_18
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 18 months of age.
OG002
B+R234_24
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.
Secondary
Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.
The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain) (N=158 116 101 138 111 93 83 56 48) For hSBA≥ 1: 5 (5/99 strain) (N=156 118 100 142 110 92 84 56 46) For hSBA≥ 1: 5 (NZ 98/254 strain) (N=159 118 103 142 111 95 86 56 48) For hSBA≥ 1: 5 (M10713 strain) (N=0 0 0 0 0 0 67 50 41)
Posted
Geometric Mean
95% Confidence Interval
Titers
1 month after booster
ID
Title
Description
OG000
B+R246_12
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.
OG001
B+R246_18
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.
Secondary
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
The analysis was performed on the per-protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
1 month after booster
ID
Title
Description
OG000
B+R246_12
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.
OG001
B246_12
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.
OG002
B+R234_12
Secondary
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain)(N=116 101 111 93 56 48 46 52), hSBA≥ 1: 5 (5/99 strain) (N=118 100 110 92 56 46 48 50), hSBA≥ 1: 5 (NZ 98/254 strain) (N=118 103 111 95 56 48 47 50)
Posted
Geometric Mean
95% Confidence Interval
Titers
1 month after booster
ID
Title
Description
OG000
B+R246_18
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.
OG001
B+R246_24
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.
Secondary
Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months
Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
The analysis was performed on the per-protocol population
Posted
Geometric Mean
95% Confidence Interval
Titers
1 month after second vaccination
ID
Title
Description
OG000
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
OG001
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
OG002
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Secondary
Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.
Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.
The analysis was performed on the per-protocol population
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after booster vaccination
ID
Title
Description
OG000
B+R246_12
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.
OG001
B+R246_18
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.
OG002
B+R246_24
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.
OG003
B246_12
Secondary
Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.
Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA
The analysis was performed on the per-protocol population
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after booster vaccination
ID
Title
Description
OG000
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
OG001
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
OG002
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Secondary
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
Analysis was done on the Safety Population.
Posted
Number
participants
From day 1 to day 7 after vaccination
ID
Title
Description
OG000
B246_12
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.
OG001
B246_18
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.
OG002
B246_24
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.
Secondary
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
The analysis was done on safety population
Posted
Number
participants
day 1 to day 7 after vaccination
ID
Title
Description
OG000
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
OG001
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
OG002
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Units
Counts
Participants
Time Frame
From day 1 to day 7 after vaccination
Description
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
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
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.
5
185
180
185
EG001
B+R246_18
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.
3
152
147
152
EG002
B+R246_24
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.
6
144
140
144
EG003
B246_12
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.
6
170
163
170
EG004
B246_18
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.
7
153
139
153
EG005
B246_24
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.
1
126
116
126
EG006
B+R234_12
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 12 months of age.
5
104
102
104
EG007
B+R234_18
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 18 months of age.
5
74
73
74
EG008
B+R234_24
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.
3
66
62
66
EG009
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
16
239
230
239
EG010
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
0
51
50
51
EG011
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
1
55
54
55
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Concussion
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG0031 affected170 at risk
EG004
Laceration
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0021 affected144 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Autism
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Petit mal Epilepsy
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Congenital aural fistula
Congenital, familial and genetic disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0021 affected144 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Walking disability
Social circumstances
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0021 affected144 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0022 affected144 at risk
EG003
Pyrexia
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Coeliac Disease
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected152 at risk
EG0020 affected144 at risk
EG003
Acetonaemic vomiting
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Arthritis reactive
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected152 at risk
EG0020 affected144 at risk
EG003
Abscess
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Ear Infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected152 at risk
EG0020 affected144 at risk
EG003
Gastroenteritis Rotavirus
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected185 at risk
EG0011 affected152 at risk
EG0020 affected144 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0002 affected185 at risk
EG0010 affected152 at risk
EG0021 affected144 at risk
EG003
Respiratory syncytial virus
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Eczema herpeticum
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Superinfection bacterial
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Viral infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Accidental exposure to product
Injury, poisoning and procedural complications
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG00014 affected185 at risk
EG00112 affected152 at risk
EG0025 affected144 at risk
EG00313 affected170 at risk
EG0048 affected153 at risk
EG0057 affected126 at risk
EG0063 affected104 at risk
EG0074 affected74 at risk
EG0082 affected66 at risk
EG00924 affected239 at risk
EG0106 affected51 at risk
EG0118 affected55 at risk
Somnolence
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG00072 affected185 at risk
EG00161 affected152 at risk
EG00272 affected144 at risk
EG003
Crying
General disorders
MedDRA 17.1
Non-systematic Assessment
EG00056 affected185 at risk
EG00143 affected152 at risk
EG00246 affected144 at risk
EG003
Induration
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0002 affected185 at risk
EG0010 affected152 at risk
EG0022 affected144 at risk
EG003
Injection site erythema
General disorders
MedDRA 17.1
Non-systematic Assessment
EG000127 affected185 at risk
EG001100 affected152 at risk
EG002109 affected144 at risk
EG003
Injection site induration
General disorders
MedDRA 17.1
Non-systematic Assessment
EG000101 affected185 at risk
EG00174 affected152 at risk
EG00276 affected144 at risk
EG003
Injection site pain
General disorders
MedDRA 17.1
Non-systematic Assessment
EG000107 affected185 at risk
EG001114 affected152 at risk
EG002118 affected144 at risk
EG003
Injection site swelling
General disorders
MedDRA 17.1
Non-systematic Assessment
EG00073 affected185 at risk
EG00153 affected152 at risk
EG00263 affected144 at risk
EG003
Pyrexia
General disorders
MedDRA 17.1
Non-systematic Assessment
EG00078 affected185 at risk
EG00157 affected152 at risk
EG00250 affected144 at risk
EG003
Swelling
General disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 affected185 at risk
EG0011 affected152 at risk
EG0022 affected144 at risk
EG003
Eating disorder
Psychiatric disorders
MedDRA 17.1
Non-systematic Assessment
EG00064 affected185 at risk
EG00170 affected152 at risk
EG00268 affected144 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 17.1
Non-systematic Assessment
EG000110 affected185 at risk
EG001100 affected152 at risk
EG00292 affected144 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0002 affected185 at risk
EG0012 affected152 at risk
EG0021 affected144 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG00039 affected185 at risk
EG00126 affected152 at risk
EG00232 affected144 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0005 affected185 at risk
EG0010 affected152 at risk
EG0021 affected144 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0008 affected185 at risk
EG0013 affected152 at risk
EG0021 affected144 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.1
Non-systematic Assessment
EG00015 affected185 at risk
EG00116 affected152 at risk
EG00211 affected144 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0009 affected185 at risk
EG0012 affected152 at risk
EG0022 affected144 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0012 affected152 at risk
EG0021 affected144 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0009 affected185 at risk
EG0019 affected152 at risk
EG00220 affected144 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0007 affected185 at risk
EG00111 affected152 at risk
EG0025 affected144 at risk
EG003
Candida nappy rash
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG00011 affected185 at risk
EG00111 affected152 at risk
EG0023 affected144 at risk
EG003
Ear infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG00012 affected185 at risk
EG0018 affected152 at risk
EG0026 affected144 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0002 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG00017 affected185 at risk
EG0016 affected152 at risk
EG0024 affected144 at risk
EG003
Infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected152 at risk
EG0022 affected144 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0003 affected185 at risk
EG0014 affected152 at risk
EG0021 affected144 at risk
EG003
Lice infestation
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected152 at risk
EG0020 affected144 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG00020 affected185 at risk
EG0016 affected152 at risk
EG00212 affected144 at risk
EG003
Otitis media
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0003 affected185 at risk
EG0016 affected152 at risk
EG0022 affected144 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0007 affected185 at risk
EG0018 affected152 at risk
EG0023 affected144 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0009 affected185 at risk
EG0013 affected152 at risk
EG0022 affected144 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG00010 affected185 at risk
EG0015 affected152 at risk
EG0024 affected144 at risk
EG003
Scarlet fever
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected152 at risk
EG0022 affected144 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0006 affected185 at risk
EG0019 affected152 at risk
EG0027 affected144 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG00010 affected185 at risk
EG0018 affected152 at risk
EG0020 affected144 at risk
EG003
Varicella
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0004 affected185 at risk
EG0011 affected152 at risk
EG0022 affected144 at risk
EG003
Viral infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG00012 affected185 at risk
EG0016 affected152 at risk
EG0026 affected144 at risk
EG003
None reported
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines
+39 0577 245863
anh.phung@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
5 subjects
FG0058 subjects
FG0062 subjects
FG0072 subjects
FG0083 subjects
FG0094 subjects
FG0100 subjects
FG0114 subjects
5 subjects
FG0057 subjects
FG0060 subjects
FG0071 subjects
FG0085 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
2 subjects
FG0053 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0094 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
174
BG004164
BG005143
BG006106
BG00778
BG00873
BG009246
BG01051
BG01156
BG0121588
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
24
± 0.4
BG00312.7± 0.9
BG00418.1± 0.5
BG00524± 0.3
BG00612.8± 1.4
BG00718± 0.4
BG00824± 0.5
BG00912.6± 1.3
BG01018± 0.2
BG01124± 0.2
BG01217.1± 4.7
77
BG00381
BG00480
BG00575
BG00662
BG00741
BG00834
BG009115
BG01023
BG01123
BG012762
Male
BG000110
BG00184
BG00275
BG00393
BG00484
BG00568
BG00644
BG00737
BG00839
BG009131
BG01028
BG01133
BG012826
Title
Measurements
OG000100(97 to 100)
OG001100(96 to 100)
OG002100(95 to 100)
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 159,118,103)
Title
Measurements
OG00095(89 to 98)
OG00177(67 to 86)
OG00284(74 to 92)
hSBA≥ 1: 5 (M10713 strain)
Title
Measurements
OG000NA(NA to NA)In this group exploratory analyses was not performed
OG001NA(NA to NA)In this group exploratory analyses was not performed
OG002NA(NA to NA)In this group exploratory analyses was not performed
B246_24
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.
Units
Counts
Participants
OG000145
OG001114
OG00298
Title
Denominators
Categories
hSBA≥ 1: 5 (H44/76 strain)(N= 138,111,93)
Title
Measurements
OG000100(97 to 100)
OG00199(94 to 100)
OG002100(95 to 100)
hSBA≥ 1: 5 (5/99 strain)(N= 142,110,92)
Title
Measurements
OG000100(97 to 100)
OG001100(96 to 100)
OG002100(95 to 100)
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 142,111,95)
Title
Measurements
OG00096(90 to 99)
OG00186(76 to 93)
OG00289(80 to 96)
hSBA≥ 1: 5 (M10713 strain)
Title
Measurements
OG000NA(NA to NA)In this group exploratory analyses was not performed
OG001NA(NA to NA)In this group exploratory analyses was not performed
OG002NA(NA to NA)In this group exploratory analyses was not performed
Units
Counts
Participants
OG00086
OG00158
OG00248
Title
Denominators
Categories
hSBA≥ 1: 5 (H44/76 strain)(N= 83,56,48 )
Title
Measurements
OG000100(94 to 100)
OG00198(88 to 100)
OG002100(91 to 100)
hSBA≥ 1: 5 (5/99 strain)(N= 84,56,46)
Title
Measurements
OG000100(94 to 100)
OG001100(92 to 100)
OG002100(90 to 100)
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 83,56,48)
Title
Measurements
OG00097(89 to 100)
OG00180(65 to 91)
OG00296(83 to 100)
hSBA≥ 1: 5 (M10713 strain)(N= 67,50,41)
Title
Measurements
OG00076(62 to 87)
OG00174(57 to 87)
OG00295(81 to 100)
OG002
B+R246_24
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.
OG003
B246_12
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.
OG004
B246_18
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.
OG005
B246_24
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.
OG006
B+R234_12
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 12 months of age.
OG007
B+R234_18
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 18 months of age.
OG008
B+R234_24
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.
Units
Counts
Participants
OG000162
OG001120
OG002108
OG003145
OG004114
OG00598
OG00686
OG00758
OG00848
Title
Denominators
Categories
hSBA≥ 1: 5 (H44/76 strain)
Title
Measurements
OG000125(106 to 148)
OG001123(101 to 149)
OG002108(88 to 133)
OG003178(149 to 213)
OG004164(135 to 200)
OG005152(122 to 188)
OG006135(108 to 170)
OG00792(70 to 121)
OG008128(95 to 172)
hSBA≥ 1: 5 (5/99 strain)
Title
Measurements
OG0001276(1092 to 1491)
OG0012183(1824 to 2611)
OG0021820(1497 to 2212)
OG003
hSBA≥ 1: 5 (NZ 98/254 strain)
Title
Measurements
OG00036(29 to 44)
OG00115(12 to 19)
OG00217(14 to 22)
OG003
hSBA≥ 1: 5 (M10713 strain)
Title
Measurements
OG000NA(NA to NA)In this group exploratory analyses was not performed.
OG001NA(NA to NA)In this group exploratory analyses was not performed.
OG002NA(NA to NA)In this group exploratory analyses was not performed.
OG003
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 12 months of age.
OG003
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
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.
OG003
B246_24
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.
OG004
B+R234_18
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 18 months of age.
OG005
B+R234_24
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.
OG006
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
OG007
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Units
Counts
Participants
OG000120
OG001108
OG002114
OG00398
OG00458
OG00548
OG00647
OG00753
Title
Denominators
Categories
hSBA≥ 1: 5 (H44/76 strain)
Title
Measurements
OG000126(104 to 154)
OG001110(89 to 136)
OG002162(132 to 198)
OG003155(124 to 193)
OG00493(70 to 123)
OG005132(97 to 180)
OG00618(13 to 25)
OG00714(10 to 19)
hSBA≥ 1: 5 (5/99 strain)
Title
Measurements
OG0002195(1790 to 2691)
OG0011811(1449 to 2262)
OG0022034(1648 to 2511)
OG003
hSBA≥ 1: 5 (NZ 98/254 strain)
Title
Measurements
OG00016(12 to 20)
OG00118(14 to 23)
OG00217(14 to 22)
OG003
Units
Counts
Participants
OG000189
OG00144
OG00249
Title
Denominators
Categories
hSBA≥ 1: 5 (H44/76 strain)(N= 156,42,45)
Title
Measurements
OG000188(164 to 216)
OG001171(130 to 224)
OG002177(136 to 231)
hSBA≥ 1: 5 (5/99 strain)(N= 177, 40,46)
Title
Measurements
OG000635(548 to 735)
OG001491(359 to 672)
OG002559(417 to 749)
hSBA≥ 1: 5 (NZ 98/254 strain)(N = 179,44,45)
Title
Measurements
OG00040(35 to 47)
OG00123(17 to 30)
OG00224(18 to 32)
hSBA≥ 1: 5 (M10713 strain)(N= 0,34,37)
Title
Measurements
OG000NA(NA to NA)In this group exploratory analyses was not performed.
OG00114(8.02 to 23)
OG00218(11 to 29)
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.
OG004
B246_18
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.
OG005
B246_24
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.
OG006
B+R234_12
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 12 months of age.
OG007
B+R234_18
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 18 months of age.
OG008
B+R234_24
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.
Units
Counts
Participants
OG000162
OG001119
OG002108
OG003145
OG004114
OG00598
OG00686
OG00758
OG00848
Title
Denominators
Categories
Title
Measurements
OG0005334(4670 to 6093)
OG0016395(5474 to 7470)
OG0026864(5826 to 8087)
OG0036605(5733 to 7609)
OG0046418(5477 to 7520)
OG0058120(6833 to 9649)
OG0066125(5110 to 7342)
OG0075952(4771 to 7426)
OG0086774(5305 to 8649)
Units
Counts
Participants
OG000177
OG00144
OG00247
Title
Denominators
Categories
Title
Measurements
OG000122(101 to 147)
OG001121(84 to 176)
OG002100(69 to 144)
Units
Counts
Participants
OG000170
OG001153
OG002126
Title
Denominators
Categories
Any
Title
Measurements
OG000156
OG001135
OG002116
Any Local
Title
Measurements
OG000137
OG001119
OG002113
Injection site Tenderness
Title
Measurements
OG000104
OG001104
OG002105
Injection site Erythema
Title
Measurements
OG000117
OG00194
OG00294
Injection site Induration
Title
Measurements
OG00093
OG00162
OG00273
Injection site Swelling
Title
Measurements
OG00057
OG00152
OG00250
Any Systemic
Title
Measurements
OG000134
OG001118
OG002101
ChangeEat.Habits
Title
Measurements
OG00066
OG00159
OG00251
Sleepiness
Title
Measurements
OG00063
OG00156
OG00252
Vomiting
Title
Measurements
OG0008
OG0019
OG0028
Diarrhea
Title
Measurements
OG00037
OG00123
OG00227
Irritbility
Title
Measurements
OG000104
OG00191
OG00283
Unusual Crying
Title
Measurements
OG00052
OG00151
OG00240
Rash
Title
Measurements
OG0007
OG0013
OG0027
Fever ( >= 38C )
Title
Measurements
OG00052
OG00155
OG00228
Any Ohter
Title
Measurements
OG00059
OG00159
OG00240
Body Temp. <38 C
Title
Measurements
OG000118
OG00198
OG00298
Medical Attend. Fever
Title
Measurements
OG0005
OG0015
OG0022
Antipyretic prophylactic
Title
Measurements
OG00032
OG00128
OG00225
Antipyretic therapeutic
Title
Measurements
OG00037
OG00139
OG00221
OG000239
OG00151
OG00255
Title
Denominators
Categories
Injection site Tenderness (vaccination 1)
Title
Measurements
OG000151
OG00135
OG00247
Injection site Tenderness (vaccination 2)
Title
Measurements
OG000143
OG00132
OG00242
Injection site Erythema (vaccination 1)
Title
Measurements
OG000151
OG00132
OG00239
Injection site Erythema (vaccination 2)
Title
Measurements
OG000148
OG00133
OG00231
Injection site Induration (vaccination 1)
Title
Measurements
OG000112
OG00120
OG00227
Injection site Induration (vaccination 2)
Title
Measurements
OG000101
OG00124
OG00222
Injection site Swelling (vaccination 1)
Title
Measurements
OG00081
OG00115
OG00219
Injection site Swelling (vaccination 2)
Title
Measurements
OG00072
OG00118
OG00219
Change in Eating habits (vaccination 1)
Title
Measurements
OG00095
OG00113
OG00225
Change in Eating habits (vaccination 2)
Title
Measurements
OG00083
OG00119
OG00221
Sleepiness (vaccination 1)
Title
Measurements
OG000106
OG00121
OG00218
Sleepiness (vaccination 2)
Title
Measurements
OG00078
OG00116
OG00218
Vomiting (vaccination 1)
Title
Measurements
OG00019
OG0015
OG0026
Vomiting (vaccination 2)
Title
Measurements
OG00018
OG0011
OG0024
Diarrhea (vaccination 1)
Title
Measurements
OG00043
OG00113
OG00220
Diarrhea (vaccination 2)
Title
Measurements
OG00035
OG0015
OG0027
Irritability (vaccination 1)
Title
Measurements
OG000156
OG00123
OG00228
Irritability (vaccination 2)
Title
Measurements
OG000126
OG00127
OG00223
Unusual Crying (vaccination 1)
Title
Measurements
OG00081
OG00113
OG00215
Unusual Crying (vaccination 2)
Title
Measurements
OG00067
OG00114
OG00215
Rash (vaccination 1)
Title
Measurements
OG00013
OG0015
OG0022
Rash (vaccination 2)
Title
Measurements
OG00010
OG0014
OG0020
Fever ( >= 38C ) (vaccination 1)
Title
Measurements
OG00083
OG00114
OG00215
Fever ( >= 38C ) (vaccination 2)
Title
Measurements
OG00074
OG00115
OG00213
Body Temp.<38 C (vaccination 1)
Title
Measurements
OG000156
OG00137
OG00239
Body Temp.<38 C (vaccination 2)
Title
Measurements
OG000163
OG00136
OG00239
Medical Attend. Fever (vaccination 1)
Title
Measurements
OG0009
OG0012
OG0021
Medical Attend. Fever (vaccination 2)
Title
Measurements
OG0005
OG0011
OG0020
Antipyretic prophylactic (vaccination 1)
Title
Measurements
OG00049
OG0018
OG0028
Antipyretic prophylactic (vaccination 2)
Title
Measurements
OG00045
OG0019
OG00211
Antipyretic therapeutic (vaccination 1)
Title
Measurements
OG00066
OG0019
OG00211
Antipyretic therapeutic (vaccination 2)
Title
Measurements
OG00054
OG00111
OG0027
1 affected
153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0111 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0081 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0061 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0041 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0061 affected104 at risk
EG0070 affected74 at risk
EG0081 affected66 at risk
EG0093 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0061 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0071 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0071 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0041 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0051 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0081 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0041 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0042 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0072 affected74 at risk
EG0080 affected66 at risk
EG0092 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0041 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0061 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0081 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0061 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0041 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0071 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0110 affected55 at risk
63 affected
170 at risk
EG00456 affected153 at risk
EG00552 affected126 at risk
EG00650 affected104 at risk
EG00733 affected74 at risk
EG00827 affected66 at risk
EG009129 affected239 at risk
EG01025 affected51 at risk
EG01128 affected55 at risk
52 affected
170 at risk
EG00451 affected153 at risk
EG00540 affected126 at risk
EG00641 affected104 at risk
EG00718 affected74 at risk
EG00822 affected66 at risk
EG009105 affected239 at risk
EG01017 affected51 at risk
EG01125 affected55 at risk
3 affected
170 at risk
EG0043 affected153 at risk
EG0054 affected126 at risk
EG0062 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0092 affected239 at risk
EG0101 affected51 at risk
EG0114 affected55 at risk
117 affected
170 at risk
EG00494 affected153 at risk
EG00594 affected126 at risk
EG00676 affected104 at risk
EG00752 affected74 at risk
EG00849 affected66 at risk
EG009179 affected239 at risk
EG01038 affected51 at risk
EG01141 affected55 at risk
93 affected
170 at risk
EG00462 affected153 at risk
EG00573 affected126 at risk
EG00652 affected104 at risk
EG00741 affected74 at risk
EG00835 affected66 at risk
EG009148 affected239 at risk
EG01027 affected51 at risk
EG01133 affected55 at risk
104 affected
170 at risk
EG004104 affected153 at risk
EG005105 affected126 at risk
EG00670 affected104 at risk
EG00756 affected74 at risk
EG00851 affected66 at risk
EG009187 affected239 at risk
EG01041 affected51 at risk
EG01151 affected55 at risk
57 affected
170 at risk
EG00452 affected153 at risk
EG00550 affected126 at risk
EG00632 affected104 at risk
EG00736 affected74 at risk
EG00825 affected66 at risk
EG009107 affected239 at risk
EG01021 affected51 at risk
EG01124 affected55 at risk
60 affected
170 at risk
EG00459 affected153 at risk
EG00532 affected126 at risk
EG00653 affected104 at risk
EG00728 affected74 at risk
EG00827 affected66 at risk
EG009133 affected239 at risk
EG01024 affected51 at risk
EG01122 affected55 at risk
1 affected
170 at risk
EG0042 affected153 at risk
EG0052 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0101 affected51 at risk
EG0113 affected55 at risk
66 affected
170 at risk
EG00459 affected153 at risk
EG00551 affected126 at risk
EG00641 affected104 at risk
EG00729 affected74 at risk
EG00828 affected66 at risk
EG009126 affected239 at risk
EG01021 affected51 at risk
EG01134 affected55 at risk
104 affected
170 at risk
EG00491 affected153 at risk
EG00583 affected126 at risk
EG00672 affected104 at risk
EG00753 affected74 at risk
EG00844 affected66 at risk
EG009177 affected239 at risk
EG01032 affected51 at risk
EG01135 affected55 at risk
2 affected
170 at risk
EG0041 affected153 at risk
EG0051 affected126 at risk
EG0061 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0092 affected239 at risk
EG0103 affected51 at risk
EG0112 affected55 at risk
40 affected
170 at risk
EG00427 affected153 at risk
EG00527 affected126 at risk
EG00621 affected104 at risk
EG00718 affected74 at risk
EG00813 affected66 at risk
EG00972 affected239 at risk
EG01016 affected51 at risk
EG01121 affected55 at risk
2 affected
170 at risk
EG0043 affected153 at risk
EG0053 affected126 at risk
EG0062 affected104 at risk
EG0071 affected74 at risk
EG0082 affected66 at risk
EG0094 affected239 at risk
EG0103 affected51 at risk
EG0111 affected55 at risk
2 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0063 affected104 at risk
EG0072 affected74 at risk
EG0080 affected66 at risk
EG00915 affected239 at risk
EG0101 affected51 at risk
EG0110 affected55 at risk
13 affected
170 at risk
EG00412 affected153 at risk
EG00510 affected126 at risk
EG00615 affected104 at risk
EG0078 affected74 at risk
EG0082 affected66 at risk
EG00941 affected239 at risk
EG0107 affected51 at risk
EG0118 affected55 at risk
6 affected
170 at risk
EG0045 affected153 at risk
EG0050 affected126 at risk
EG0062 affected104 at risk
EG0074 affected74 at risk
EG0080 affected66 at risk
EG00913 affected239 at risk
EG0101 affected51 at risk
EG0112 affected55 at risk
1 affected
170 at risk
EG0042 affected153 at risk
EG0052 affected126 at risk
EG0061 affected104 at risk
EG0070 affected74 at risk
EG0081 affected66 at risk
EG0093 affected239 at risk
EG0101 affected51 at risk
EG0113 affected55 at risk
8 affected
170 at risk
EG0045 affected153 at risk
EG0059 affected126 at risk
EG00610 affected104 at risk
EG0077 affected74 at risk
EG0085 affected66 at risk
EG00926 affected239 at risk
EG0108 affected51 at risk
EG0114 affected55 at risk
19 affected
170 at risk
EG0047 affected153 at risk
EG0055 affected126 at risk
EG0069 affected104 at risk
EG0076 affected74 at risk
EG0084 affected66 at risk
EG00919 affected239 at risk
EG0103 affected51 at risk
EG0119 affected55 at risk
0 affected
170 at risk
EG0040 affected153 at risk
EG0051 affected126 at risk
EG0061 affected104 at risk
EG0071 affected74 at risk
EG0080 affected66 at risk
EG0092 affected239 at risk
EG0103 affected51 at risk
EG0111 affected55 at risk
10 affected
170 at risk
EG00410 affected153 at risk
EG0057 affected126 at risk
EG0065 affected104 at risk
EG0071 affected74 at risk
EG0083 affected66 at risk
EG00915 affected239 at risk
EG0104 affected51 at risk
EG0114 affected55 at risk
13 affected
170 at risk
EG0045 affected153 at risk
EG0056 affected126 at risk
EG00614 affected104 at risk
EG0075 affected74 at risk
EG0083 affected66 at risk
EG00929 affected239 at risk
EG0106 affected51 at risk
EG0114 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0061 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0101 affected51 at risk
EG0113 affected55 at risk
9 affected
170 at risk
EG0045 affected153 at risk
EG0057 affected126 at risk
EG0064 affected104 at risk
EG0072 affected74 at risk
EG0080 affected66 at risk
EG00910 affected239 at risk
EG0104 affected51 at risk
EG0112 affected55 at risk
0 affected
170 at risk
EG0043 affected153 at risk
EG0052 affected126 at risk
EG0062 affected104 at risk
EG0071 affected74 at risk
EG0081 affected66 at risk
EG0092 affected239 at risk
EG0103 affected51 at risk
EG0113 affected55 at risk
3 affected
170 at risk
EG0042 affected153 at risk
EG0051 affected126 at risk
EG0060 affected104 at risk
EG0072 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0101 affected51 at risk
EG0115 affected55 at risk
1 affected
170 at risk
EG0040 affected153 at risk
EG0050 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0090 affected239 at risk
EG0100 affected51 at risk
EG0114 affected55 at risk
13 affected
170 at risk
EG00412 affected153 at risk
EG0054 affected126 at risk
EG0067 affected104 at risk
EG0075 affected74 at risk
EG0082 affected66 at risk
EG00921 affected239 at risk
EG0108 affected51 at risk
EG0117 affected55 at risk
6 affected
170 at risk
EG0044 affected153 at risk
EG0052 affected126 at risk
EG0063 affected104 at risk
EG0072 affected74 at risk
EG0084 affected66 at risk
EG00911 affected239 at risk
EG0102 affected51 at risk
EG0114 affected55 at risk
5 affected
170 at risk
EG00414 affected153 at risk
EG0056 affected126 at risk
EG0065 affected104 at risk
EG0073 affected74 at risk
EG0083 affected66 at risk
EG00916 affected239 at risk
EG0103 affected51 at risk
EG0111 affected55 at risk
6 affected
170 at risk
EG0043 affected153 at risk
EG0053 affected126 at risk
EG0065 affected104 at risk
EG0072 affected74 at risk
EG0082 affected66 at risk
EG0098 affected239 at risk
EG0105 affected51 at risk
EG0116 affected55 at risk
12 affected
170 at risk
EG0044 affected153 at risk
EG0057 affected126 at risk
EG0064 affected104 at risk
EG0073 affected74 at risk
EG0081 affected66 at risk
EG00917 affected239 at risk
EG0102 affected51 at risk
EG0115 affected55 at risk
0 affected
170 at risk
EG0042 affected153 at risk
EG0051 affected126 at risk
EG0060 affected104 at risk
EG0070 affected74 at risk
EG0080 affected66 at risk
EG0091 affected239 at risk
EG0103 affected51 at risk
EG0110 affected55 at risk
9 affected
170 at risk
EG0046 affected153 at risk
EG0053 affected126 at risk
EG0065 affected104 at risk
EG0073 affected74 at risk
EG0083 affected66 at risk
EG00914 affected239 at risk
EG0102 affected51 at risk
EG0113 affected55 at risk
6 affected
170 at risk
EG00415 affected153 at risk
EG0055 affected126 at risk
EG00610 affected104 at risk
EG0072 affected74 at risk
EG0080 affected66 at risk
EG00918 affected239 at risk
EG0102 affected51 at risk
EG0115 affected55 at risk
2 affected
170 at risk
EG0042 affected153 at risk
EG0057 affected126 at risk
EG0062 affected104 at risk
EG0070 affected74 at risk
EG0085 affected66 at risk
EG0099 affected239 at risk
EG0105 affected51 at risk
EG0111 affected55 at risk
7 affected
170 at risk
EG00410 affected153 at risk
EG0055 affected126 at risk
EG0065 affected104 at risk
EG0075 affected74 at risk
EG0086 affected66 at risk
EG00921 affected239 at risk
EG0108 affected51 at risk
EG0113 affected55 at risk
1713
(1454 to 2020)
OG0042058(1710 to 2476)
OG0052739(2233 to 3361)
OG0061558(1262 to 1923)
OG0071486(1148 to 1924)
OG0082081(1564 to 2771)
34
(27 to 42)
OG00417(14 to 22)
OG00519(15 to 25)
OG00647(36 to 62)
OG00717(12 to 24)
OG00833(23 to 47)
NA
(NA to NA)
In this group exploratory analyses was not performed.
OG004NA(NA to NA)In this group exploratory analyses was not performed.
OG005NA(NA to NA)In this group exploratory analyses was not performed.