Extension Study of V72P13 to Evaluate the Safety, Tolerab... | NCT00847145 | Trialant
NCT00847145
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Mar 3, 2015Estimated
Enrollment
2,249Actual
Phase
Phase 3
Conditions
Meningococcal Disease
Interventions
1a - rMenB+OMV NZ and routine vaccines
1b - rMenB+OMV NZ and routine vaccines
2a - Routine and rMenB+OMV NZ vaccines
2b - rMenB+OMV NZ and routine vaccines
3a - rMenB+OMV NZ and routine vaccines
3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
4a- rMenB+OMV NZ and routine vaccines
4b - rMenB+OMV NZ and routine vaccines
Countries
Austria
Czechia
Finland
Germany
Italy
Protocol Section
Identification Module
NCT ID
NCT00847145
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V72P13E1
Secondary IDs
ID
Type
Description
Link
2008-006301-17
EudraCT Number
Brief Title
Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
Official Title
A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Mar 2015
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
Feb 2009
Primary Completion Date
Aug 2010Actual
Completion Date
Aug 2010Actual
First Submitted Date
Feb 18, 2009
First Submission Date that Met QC Criteria
Feb 18, 2009
First Posted Date
Feb 19, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 3, 2015
Results First Submitted that Met QC Criteria
Mar 2, 2015
Results First Posted Date
Mar 3, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 2, 2015
Last Update Posted Date
Mar 3, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers
Detailed Description
Not provided
Conditions Module
Conditions
Meningococcal Disease
Keywords
toddler
Meningococcal disease
prevention
vaccination
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,249Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
12B12M (1a)
Experimental
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
Biological: 1a - rMenB+OMV NZ and routine vaccines
12B13M (1b)
Experimental
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
Biological: 1b - rMenB+OMV NZ and routine vaccines
12M13B15B (2a)
Experimental
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
Biological: 2a - Routine and rMenB+OMV NZ vaccines
12M12B14B (2b)
Experimental
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
1a - rMenB+OMV NZ and routine vaccines
Biological
One dose of rMenB vaccine and routine vaccine at study month 12.
12B12M (1a)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.
one month after the booster (fourth) dose
Secondary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone.
The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
Exclusion Criteria:
Previous ascertained or suspected disease caused by N. meningitidis;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Any serious chronic or progressive disease
Known or suspected impairment/ alteration of the immune system,
Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.
Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019 May 19;9(5):e026953. doi: 10.1136/bmjopen-2018-026953.
Subjects were enrolled at 15 sites in Finland, 12 sites in Germany, 5 sites in Austria, 27 sites in Czech Republic and 6 sites in Italy.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
12B12M (1a)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
FG001
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: 2b - rMenB+OMV NZ and routine vaccines
12B12M (3a)
Experimental
Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
Biological: 3a - rMenB+OMV NZ and routine vaccines
12B13M (3b)
Experimental
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
12B12M_C (4a)
Experimental
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
Biological: 4a- rMenB+OMV NZ and routine vaccines
12B13M_C (4b)
Experimental
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
Biological: 4b - rMenB+OMV NZ and routine vaccines
1b - rMenB+OMV NZ and routine vaccines
Biological
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
12B13M (1b)
2a - Routine and rMenB+OMV NZ vaccines
Biological
One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
12M13B15B (2a)
2b - rMenB+OMV NZ and routine vaccines
Biological
Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
12M12B14B (2b)
3a - rMenB+OMV NZ and routine vaccines
Biological
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
12B12M (3a)
3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
Biological
One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
12B13M (3b)
4a- rMenB+OMV NZ and routine vaccines
Biological
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
12B12M_C (4a)
4b - rMenB+OMV NZ and routine vaccines
Biological
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
12B13M_C (4b)
one month after booster (fourth) dose
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
one month after booster (fourth) vaccination.
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
one month after third vaccination and pre dose fourth (booster) vaccination
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
One month post vaccination and pe-booster (fourth) dose vaccination
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.
one month after booster (fourth) dose vaccination and pre-fourth dose vaccination
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.
One month after the second dose.
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.
One month after the second dose.
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months
The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
One month after the fourth (booster) dose.
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.
One month after the first dose and one month after the second dose.
Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months
The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
One month after the fourth (booster) dose.
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.
From day 1 to day 7 after each rMenB+OMV NZ vaccination.
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).
From day 1 to day 7 after each rMenB+MV NZ vaccination.
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
From day 1 to day 7 after MMRV vaccination.
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
From day 8 to day 28 after MMRV vaccination.
Hall in Tirol
6060
Austria
Häckel
Kirchdorf
4560
Austria
Prieler
Neufeld A.d. Leitha
2491
Austria
Maurer
Salzburg
5020
Austria
Sommer
Vienna
1230
Austria
Angermayr
Wels
4600
Austria
Site 27
Boskovice
680 01
Czechia
Site 19
Brno
628 00
Czechia
Site 22
Chomutov
430 03
Czechia
Site 12
Havlíčkův Brod
580 22
Czechia
Fakulta vojenskeho zdravotnictví
Hradec Králové
500 01
Czechia
Site 28
Hranice I-mesto
753 01
Czechia
Site 13
Humpolec
396 01
Czechia
Site 25
Kladno
272 00
Czechia
Site 21
Kolín
280 02
Czechia
Site 10
Liberec
460 15
Czechia
Site 24
Litoměřice
412 01
Czechia
Site 17
Ostrava
702 00
Czechia
Site 18
Ostrava-Poruba
708 68
Czechia
Site 16
Pilsen
305 99
Czechia
Site 26
Rumburk
408 01
Czechia
Site 23
Ústí nad Labem
400 01
Czechia
Site 30
Espoo
02100
Finland
Site 31
Helsinki
00100
Finland
Site 32
Helsinki
00930
Finland
Site 34
Jarvenpaa
04400
Finland
Site 35
Kokkola
67100
Finland
Site 45
Kotka
48600
Finland
Site 46
Kuopio
70100
Finland
Site 47
Lahti
15140
Finland
Site 49
Oulu
90220
Finland
Site 50
Pori
28100
Finland
Site 51
Seinäjoki
60100
Finland
Site 52
Tampere
33100
Finland
Site 53
Turku
20520
Finland
Site 33
Vantaa
01300
Finland
Site 48
Vantaa
01600
Finland
Site 99
Detmold
32756
Germany
Site 92
Espelkamp
32339
Germany
Site 95
Freising
85354
Germany
Site 64
Fulda
36037
Germany
Site 58
Lauffen am Neckar
74348
Germany
Site 57
Marbach A. N.
71672
Germany
Site 80
München
80337
Germany
Site 83
München
81241
Germany
Site 97
München
81377
Germany
Site 96
München
81475
Germany
Site 91
Műnchen
81737
Germany
Site 81
Porta Westfalica
32457
Germany
Site 65
Schwieberdingen
71701
Germany
Site 94
Weilheim
82362
Germany
Dipartimento di Scienze della Salute
Genova
Genova
16132
Italy
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
Milan
Milano
20122
Italy
Pediatria dell' Ospedale Sacco
Milan
Milano
20157
Italy
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
Sassari
Sassari
07100
Italy
ASL/TA
Taranto
Taranto
74100
Italy
Universita degli Studi di Messina, Policlinico G. Martino
Messina
Italy
Ospedale Maggiore di Novara
Novara
28100
Italy
Derived
Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. doi: 10.1016/S0140-6736(12)61961-8.
12B13M (1b)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
FG002
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
FG003
12M12B14B (2b)
Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
FG004
12B12M (3a)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
FG005
12B13M (3b)
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
FG006
12B12M_C (4a)
Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
FG007
12B13M_C (4b)
Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
FG000629 subjects
FG001633 subjects
FG002285 subjects
FG003117 subjects
FG004137 subjects
FG005156 subjects
FG006152 subjects
FG007140 subjects
COMPLETED
FG000623 subjects
FG001627 subjects
FG002274 subjects
FG003116 subjects
FG004131 subjects
FG005152 subjects
FG006143 subjects
FG007136 subjects
NOT COMPLETED
FG0006 subjects
FG0016 subjects
FG00211 subjects
FG0031 subjects
FG0046 subjects
FG0054 subjects
FG0069 subjects
FG0074 subjects
Type
Comment
Reasons
AE or Death
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0003 subjects
FG0014 subjects
FG0026 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Inappropriate enrollment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
BG001
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
BG002
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
BG003
12M12B14B (2b)
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
BG004
12B12M (3a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
BG005
12B13M (3b)
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
BG006
12B12M_C (4a)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
BG007
12B13M_C (4b)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000629
BG001633
BG002285
BG003117
BG004137
BG005156
BG006152
BG007140
BG0082249
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00012.3± 0.5
BG00112.3± 0.5
BG00212.3± 0.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000290
BG001330
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 the Booster Dose of rMenB+OMV NZ Vaccination
Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.
The analysis was done on Per Protocol (PP) population - subjects who received all doses of vaccine in parent & present study, provided evaluable serum samples at 1 month after booster dose or 1 month after 2nd dose, blood draw at 1 month after 3rd injection at 6 months in parent & visit 1 blood draw in present study, had no major protocol violation
Posted
Number
95% Confidence Interval
Percentages of subjects
one month after the booster (fourth) dose
ID
Title
Description
OG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
OG001
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
Units
Counts
Participants
OG000211
OG001215
Title
Denominators
Categories
Strain 44/76-SL (Baseline) (N=211, 215)
Title
Measurements
OG00081(75 to 86)
OG00182(77 to 87)
One month after booster (N=210, 212)
Title
Measurements
OG000
Secondary
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone.
The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection.
This analysis was done on Per Protocol (PP) population.
Posted
Number
95% Confidence Interval
Percentages of subjects
one month after booster (fourth) dose
ID
Title
Description
OG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine.
OG001
12M13B15B (2a)
Previously in the parent study subjects had received only routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age in the present study.
Secondary
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
This analysis was done on PP population.
Posted
Geometric Mean
95% Confidence Interval
Titers
one month after booster (fourth) vaccination.
ID
Title
Description
OG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
OG001
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
Units
Counts
Participants
Secondary
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
Posted
Geometric Mean
95% Confidence Interval
Titers
one month after third vaccination and pre dose fourth (booster) vaccination
ID
Title
Description
OG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
OG001
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
OG002
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
Secondary
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
The analysis was done on PP population.
Posted
Number
95% Confidence Interval
Percentages of subjects
One month post vaccination and pe-booster (fourth) dose vaccination
ID
Title
Description
OG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
OG001
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
OG002
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
Secondary
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.
This analysis was done on the PP population.
Posted
Geometric Mean
95% Confidence Interval
Titers
one month after booster (fourth) dose vaccination and pre-fourth dose vaccination
ID
Title
Description
OG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
OG001
12M12B14B (2b)
Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine was given concomitantly at 12 months of age in the present study
Secondary
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.
The analysis was done on the SBA PP Catch-up population.
Posted
Geometric Mean
95% Confidence Interval
Titers
One month after the second dose.
ID
Title
Description
OG000
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
OG001
12M12B14B (2b)
Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
Units
Counts
Participants
Secondary
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.
Posted
Number
95% Confidence Interval
Percentages of Subjects
One month after the second dose.
ID
Title
Description
OG000
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
OG001
12M12B14B (2b)
Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
Units
Counts
Participants
Secondary
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months
The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
The analysis was done on the SBA PP Booster population.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
One month after the fourth (booster) dose.
ID
Title
Description
OG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
OG001
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
Units
Counts
Participants
Secondary
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.
The analysis was done on the SBA PP Catch-up population.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
One month after the first dose and one month after the second dose.
ID
Title
Description
OG000
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
OG001
12M12B14B (2b)
Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
Units
Counts
Secondary
Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months
The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
The analysis was done on the SBA PP Booster population.
Posted
Number
95% Confidence Interval
Percentages of Subjects
One month after the fourth (booster) dose.
ID
Title
Description
OG000
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
OG001
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
Units
Counts
Secondary
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.
Analysis performed on the Safety population.
Posted
Number
Subjects
From day 1 to day 7 after each rMenB+OMV NZ vaccination.
ID
Title
Description
OG000
12B12M_C (4a)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
OG001
12B13M_C (4b)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
OG002
12B12M
Secondary
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).
Analysis performed on the Safety population.
Posted
Number
Subjects
From day 1 to day 7 after each rMenB+MV NZ vaccination.
ID
Title
Description
OG000
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
OG001
12M12B14B (2b)
Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
Units
Counts
Secondary
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
Analysis performed on the Safety population.
Posted
Number
Subjects
From day 1 to day 7 after MMRV vaccination.
ID
Title
Description
OG000
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
OG001
12M12B14B (2b)
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
Secondary
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
Analysis performed on the Safety population.
Posted
Number
Subjects
From day 8 to day 28 after MMRV vaccination.
ID
Title
Description
OG000
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
OG001
12M12B14B (2b)
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
Time Frame
All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
12B12M
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
This group is a combination of Groups 12B12M (1a) and 12B12M (3a) for safety data analysis purposes.
28
765
754
765
EG001
12B13M
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
This group is a combination of Groups 12B13M (1b) and 12B13M (3b) for safety data analysis purposes.
40
789
760
789
EG002
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
27
284
282
284
EG003
12M12B14B (2b)
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
9
117
116
117
EG004
12B12M_C (4a)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
7
152
145
152
EG005
12B13M_C (4b)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
4b - rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
2
139
132
139
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Kawasaki's disease
Vascular disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected765 at risk
EG0010 events0 affected789 at risk
EG0021 events1 affected284 at risk
EG0030 events0 affected117 at risk
EG0040 events0 affected152 at risk
EG0050 events0 affected139 at risk
Strabismus correction
Surgical and medical procedures
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected765 at risk
EG0011 events1 affected789 at risk
EG0020 events0 affected284 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected765 at risk
EG0010 events0 affected789 at risk
EG0021 events1 affected284 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the measles antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Measles antigen was greater than -10%.
Percentage group difference
-1
2-Sided
95
-5
2
Yes
Non-Inferiority or Equivalence
The specified cut-off levels for the vaccine antigen measles is ≥255 mIU/mL to be greater than -10%.
OG000
OG001
The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B(2a), if for the mumps antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Mumps antigen was greater than -10%.
Percentage group difference
0
2-Sided
95
-5
5
Yes
Non-Inferiority or Equivalence
The specified cut-off level for the vaccine antigen mumps is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody (Ab) units to be greater than -10%.
OG000
OG001
The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the rubella antigen(two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for rubella antigen was greater than -10%.
Percentage group difference
-1
2-Sided
95
-4
1
Yes
Non-Inferiority or Equivalence
The specified cut-off level for the vaccine antigen rubella is ≥10 IU/mL to be greater than -10%.
OG000
OG001
The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for varicella antigen was greater than -10%.
Percentage group difference
-1
2-Sided
95
-6
3
Yes
Non-Inferiority or Equivalence
The specified cut-off value for the vaccine antigen varicella is ≥1.25 gpELISA units/mL to be greater than -10%.
OG000
OG001
The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of the subjects with antibody response greater than or equal to the specified cut-off value for varicella antigen was greater than -10%.
Percentage group difference
-2
2-Sided
95
-11
7
Yes
Non-Inferiority or Equivalence
The specified cut-off level for the varicella vaccine antigen is ≥5 gp ELISA units/ml (seroprotection) to be greater than -10%.
OG000211
OG001215
Title
Denominators
Categories
Strain 44/76-SL (Baseline)
Title
Measurements
OG00011(9.27 to 12)
OG00110(9.11 to 12)
1 Month after booster (N=210, 212)
Title
Measurements
OG000139(123 to 156)
OG001119(105 to 133)
Strain 5/99 (N=210, 213)
Title
Measurements
OG00081(71 to 93)
OG00181(71 to 92)
1 Month after booster (N=209, 212)
Title
Measurements
OG0001503(1339 to 1686)
OG0011429(1274 to 1603)
Strain NZ98/254 (N=211, 215)
Title
Measurements
OG0002.07(1.8 to 2.38)
OG0012.21(1.92 to 2.55)
1 Month after booster (N=211,213)
Title
Measurements
OG00039(33 to 46)
OG00132(27 to 37)
OG003
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
Units
Counts
Participants
OG000139
OG001133
OG002272
OG00351
Title
Denominators
Categories
Strain 44/76-SL (Baseline) N=134, 131, 265,49
Title
Measurements
OG0001.15(1.05 to 1.27)
OG0011.15(1.05 to 1.27)
OG0021.15(1.08 to 1.24)
OG0031.14(0.99 to 1.32)
1 M after 3rd vac.in parent study N=139,133,272,51
Title
Measurements
OG00091(81 to 104)
OG00183(73 to 94)
OG00287(79 to 95)
OG003
Pre-Boodster vac.in present study N=139,133,272,51
Title
Measurements
OG00011(9 to 12)
OG00110(8.7 to 12)
OG00210(9.28 to 12)
OG003
Strain 5/99 (Baseline) N=132,129,261,49
Title
Measurements
OG0001.13(1.01 to 1.26)
OG0011.24(1.11 to 1.39)
OG0021.18(1.09 to 1.28)
OG003
1M after 3rd vac. in parent study N=139,133,272,51
Title
Measurements
OG000615(538 to 704)
OG001620(540 to 712)
OG002617(560 to 680)
OG003
Pre-Booster vac.in present study N=139,133,272,51
Title
Measurements
OG00085(72 to 100)
OG00179(67 to 94)
OG00282(73 to 92)
OG003
Strain NZ98/254 (Baseline) N=135,130,265,49
Title
Measurements
OG0001.05(0.98 to 1.13)
OG0011.12(1.04 to 1.21)
OG0021.09(1.03 to 1.15)
OG003
1M after 3rd vac. in parent study.N=139,132,271,52
Title
Measurements
OG00012(10 to 15)
OG00114(12 to 17)
OG00213(11 to 15)
OG003
Pre-booster vac in present study. N=139,132,271,52
Title
Measurements
OG0002.04(1.72 to 2.43)
OG0012.02(1.69 to 2.42)
OG0022.03(1.79 to 2.3)
OG003
OG003
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
Units
Counts
Participants
OG000139
OG001133
OG002272
OG00351
Title
Denominators
Categories
44/76-SL Baseline in present studyN=134,131,265,49
Title
Measurements
OG0003(1 to 7)
OG0013(1 to 8)
OG0023(1 to 6)
OG0034(0 to 14)
1 M after 3rd vac in parent study.N=139,133,272,51
Title
Measurements
OG000100(97 to 100)
OG00199(96 to 100)
OG002100(98 to 100)
OG003
Pre-booster vac. in present study.N=139,133,272,51
Title
Measurements
OG00081(73 to 87)
OG00182(74 to 88)
OG00281(76 to 86)
OG003
5/99 Baseline in parent study N=132,129,261,49
Title
Measurements
OG0004(1 to 9)
OG0015(2 to 10)
OG0024(2 to 7)
OG003
1M after 3rd vac in parent study N=139,133,272,51
Title
Measurements
OG000100(97 to 100)
OG00199(96 to 100)
OG002100(98 to 100)
OG003
Pre-Boostervac.in present study N=139,133,272,51
Title
Measurements
OG00098(94 to 100)
OG001100(97 to 100)
OG00299(97 to 100)
OG003
NZ98/254 Baseline in parent study N=135,130,265,49
Title
Measurements
OG0001(0.019 to 4)
OG0014(1 to 9)
OG0022(1 to 5)
OG003
1 M after 3rd vac. in parent studyN=139,132,271,52
Title
Measurements
OG00081(74 to 87)
OG00185(78 to 90)
OG00283(78 to 87)
OG003
Pre-Booster vac in present study N=139,132,271,52
Title
Measurements
OG00021(14 to 29)
OG00120(13 to 28)
OG00220(16 to 26)
OG003
Units
Counts
Participants
OG000211
OG00172
Title
Denominators
Categories
44/76-SL (Baseline) (N=211, 71)
Title
Measurements
OG00011(9.32 to 12)
OG0011.18(0.96 to 1.46)
1 M after Booster or 1st rMenB (N=210, 71)
Title
Measurements
OG000140(123 to 159)
OG00115(12 to 19)
5/99 (Baseline) (N=210, 71)
Title
Measurements
OG00083(73 to 93)
OG0011(0.81 to 1.24)
1 M after Booster or 1sr rMenB (N=209, 72)
Title
Measurements
OG0001538(1337 to 1769)
OG00158(46 to 74)
NZ98/254 (Baseline) (N=211, 71)
Title
Measurements
OG0002.05(1.83 to 2.31)
OG0011.03(0.84 to 1.26)
1M after Booster or 1st rMenB (N=211, 72)
Title
Measurements
OG00039(34 to 46)
OG0014.18(3.18 to 5.5)
OG000164
OG00168
Title
Denominators
Categories
Strain H44/76, Baseline (N=161,67)
Title
Measurements
OG0001.24(1.15 to 1.35)
OG0011.22(1.07 to 1.38)
1 M after 2nd Vac. (N=163, 67)
Title
Measurements
OG000271(237 to 310)
OG001248(201 to 306)
Strain 5/99, Baseline (N=160, 67)
Title
Measurements
OG0001.06(1 to 1.13)
OG0011.03(0.94 to 1.13)
1 M after 2nd Vac. (N=164, 67)
Title
Measurements
OG000599(520 to 690)
OG001627(502 to 783)
Strain NZ98/254, Baseline (N=162, 67)
Title
Measurements
OG0001.03(0.98 to 1.07)
OG0011.03(0.97 to 1.1)
1M after 2nd Vac. (N=164, 68)
Title
Measurements
OG00043(38 to 49)
OG00132(26 to 40)
OG000164
OG00168
Title
Denominators
Categories
Strain H44/76, Baseline (N=161,67)
Title
Measurements
OG0005(2 to 10)
OG0013(0 to 10)
1 M after 2nd Vac. (N=163, 67)
Title
Measurements
OG000100(98 to 100)
OG001100(95 to 100)
Strain 5/99, Baseline (N=160, 67)
Title
Measurements
OG0001(0 to 4)
OG0011(0.038 to 8)
1 M after 2nd Vac. (N=164, 67)
Title
Measurements
OG000100(98 to 100)
OG001100(95 to 100)
Strain NZ98/254, Baseline (N=162, 67)
Title
Measurements
OG0001(0.016 to 3)
OG0010(0 to 5)
1M after 2nd Vac. (N=164, 68)
Title
Measurements
OG000100(98 to 100)
OG00196(88 to 99)
OG000213
OG001216
Title
Denominators
Categories
Baseline (N=212,216)
Title
Measurements
OG000390(351 to 433)
OG001389(349 to 434)
1 M after Booster (N=213, 214)
Title
Measurements
OG0006225(5571 to 6956)
OG0015608(5111 to 6154)
Participants
OG000165
OG00168
Title
Denominators
Categories
Baseline (N=162,66)
Title
Measurements
OG00020(20 to 21)
OG00122(19 to 24)
1 M after 1st Vac. (N=162,64)
Title
Measurements
OG000113(95 to 136)
OG001120(88 to 164)
1 M after 2nd Vac.
Title
Measurements
OG0005698(5030 to 6454)
OG0017154(5880 to 8704)
Participants
OG00019
OG00127
Title
Denominators
Categories
Pre-Booster Vac.
Title
Measurements
OG00084(60 to 97)
OG00159(39 to 78)
1 Month After Booster
Title
Measurements
OG000100(82 to 100)
OG001100(87 to 100)
Combination of Groups 12B12M (1a) and 12B12M (3a).
OG003
12B13M
Combination of Groups 12B13M (1b) and 12B13M (3b).
Units
Counts
Participants
OG000152
OG001138
OG002765
OG003789
Title
Denominators
Categories
Any local
Title
Measurements
OG000113
OG001104
OG002639
OG003673
MenB Tenderness
Title
Measurements
OG00097
OG00180
OG002546
OG003
MenB Erythema
Title
Measurements
OG00078
OG00181
OG002504
OG003
MenB Induration
Title
Measurements
OG00061
OG00161
OG002388
OG003
MenB Swelling
Title
Measurements
OG00044
OG00139
OG002284
OG003
Any systemic
Title
Measurements
OG000133
OG001117
OG002695
OG003
Change Eat. Habits
Title
Measurements
OG00061
OG00144
OG002312
OG003
Sleepiness
Title
Measurements
OG00064
OG00160
OG002362
OG003
Vomiting
Title
Measurements
OG0009
OG00110
OG00254
OG003
Diarrhea
Title
Measurements
OG00029
OG00123
OG002188
OG003
Irritability
Title
Measurements
OG00089
OG00175
OG002560
OG003
Unusual Crying
Title
Measurements
OG00048
OG00148
OG002327
OG003
Rash
Title
Measurements
OG0008
OG0017
OG00257
OG003
Rash Oth.to Fever
Title
Measurements
OG0006
OG0010
OG00231
OG003
Rash Urt.to Fever
Title
Measurements
OG0002
OG0010
OG00218
OG003
Rash Oth.to Doc.
Title
Measurements
OG0006
OG0010
OG00235
OG003
Rash Urt.to Doc.
Title
Measurements
OG0002
OG0010
OG00223
OG003
Gland Swelling
Title
Measurements
OG0004
OG0010
OG00212
OG003
Gland Par.to Doc.
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gland Sal.to Doc.
Title
Measurements
OG0000
OG0010
OG0020
OG003
Med. Att. Fever
Title
Measurements
OG0003
OG0014
OG0028
OG003
Fever ( ≥ 38C )
Title
Measurements
OG00087
OG00174
OG002356
OG003
Antipyretic Med. Used
Title
Measurements
OG00079
OG00169
OG002436
OG003
Participants
OG000284
OG001117
Title
Denominators
Categories
Any local (1st vacc)
Title
Measurements
OG000211
OG00192
Any local (2nd vacc)
Title
Measurements
OG000212
OG00190
MenB Tenderness (1st vacc)
Title
Measurements
OG000158
OG00167
MenB Tenderness (2nd vacc)
Title
Measurements
OG000181
OG00178
MenB Erythema (1st vacc)
Title
Measurements
OG000173
OG00179
MenB Erythema (2nd vacc)
Title
Measurements
OG000159
OG00170
MenB Induration (1st vacc)
Title
Measurements
OG000111
OG00157
MenB Induration (2nd vacc)
Title
Measurements
OG000115
OG00153
MenB Swelling (1st vacc)
Title
Measurements
OG00081
OG00136
MenB Swelling (2nd vacc)
Title
Measurements
OG00083
OG00133
Any systemic (1st vacc)
Title
Measurements
OG000216
OG001104
Change Eat. Habits (1st vacc)
Title
Measurements
OG00096
OG00144
Any systemic (2nd vacc)
Title
Measurements
OG000224
OG00199
Change Eat. Habits (2nd vacc)
Title
Measurements
OG00083
OG00143
Sleepiness (1st vacc)
Title
Measurements
OG000110
OG00155
Sleepiness (2nd vacc)
Title
Measurements
OG000106
OG00148
Vomiting (1st vacc)
Title
Measurements
OG00014
OG0012
Vomiting (2nd vacc)
Title
Measurements
OG0008
OG0013
Diarrhea (1st vacc)
Title
Measurements
OG00041
OG00134
Diarrhea (2nd vacc)
Title
Measurements
OG00041
OG00125
Irritability (1st vacc)
Title
Measurements
OG000168
OG00182
Irritability (2nd vacc)
Title
Measurements
OG000153
OG00173
Unusual Crying (1st vacc)
Title
Measurements
OG00080
OG00141
Unusual Crying (2nd vacc)
Title
Measurements
OG00074
OG00142
Rash (1st vacc)
Title
Measurements
OG00013
OG0019
Rash (2nd vacc)
Title
Measurements
OG00010
OG0014
Rash Oth.to Fever (1st vacc)
Title
Measurements
OG0000
OG0010
Rash Oth.to Fever (2nd vacc)
Title
Measurements
OG0000
OG0010
Rash Urt.to Fever (1st vacc)
Title
Measurements
OG0000
OG0010
Rash Urt.to Fever (2nd vacc)
Title
Measurements
OG0000
OG0010
Rash Oth.to Doc. (1st vacc)
Title
Measurements
OG0000
OG0010
Rash Oth.to Doc. (2nd vacc)
Title
Measurements
OG0000
OG0010
Rash Urt.to Doc. (1st vacc)
Title
Measurements
OG0000
OG0010
Rash Urt.to Doc. (2nd vacc)
Title
Measurements
OG0000
OG0010
Gland Swelling (1st vacc)
Title
Measurements
OG0000
OG0011
Gland Swelling (2nd vacc)
Title
Measurements
OG0000
OG0010
Gland Par.to Doc. (1st vacc)
Title
Measurements
OG0000
OG0010
Gland Par.to Doc. (2nd vacc)
Title
Measurements
OG0000
OG0010
Gland Sal.to Doc. (1st vacc)
Title
Measurements
OG0000
OG0010
Gland Sal.to Doc. (2nd vacc)
Title
Measurements
OG0000
OG0010
Med. Att. Fever (1st vacc)
Title
Measurements
OG0000
OG0011
Med. Att. Fever (2nd vacc)
Title
Measurements
OG0002
OG0012
Fever (≥ 38C) (1st vacc)
Title
Measurements
OG000103
OG00154
Fever (≥ 38C) (2nd vacc)
Title
Measurements
OG00097
OG00150
Antipyr. Med. Used (1st vacc)
Title
Measurements
OG000119
OG00167
Antipyretic Med. Used (2nd vacc)
Title
Measurements
OG000107
OG00158
OG002
12B12M_C (4a)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
OG003
12B12M
Combination of Groups 12B12M (1a) and 12B12M (3a).
Units
Counts
Participants
OG000284
OG001117
OG002152
OG003760
Title
Denominators
Categories
MMRV Tenderness
Title
Measurements
OG00056
OG00139
OG00268
OG003353
MMRV Erythema
Title
Measurements
OG000120
OG00152
OG00260
OG003
MMRV Induration
Title
Measurements
OG00053
OG00118
OG00230
OG003
MMRV Swelling
Title
Measurements
OG00031
OG00111
OG00228
OG003
OG002
12B12M_C (4a)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
OG003
12B12M
Combination of Groups 12B12M (1a) and 12B12M (3a).