Safety and Immunogenicity in Dose-Ranging and Formulation... | NCT00937521 | Trialant
NCT00937521
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Apr 7, 2015Estimated
Enrollment
1,507Actual
Phase
Phase 2
Conditions
Meningococcal Meningitis
Meningococcal Infections
Interventions
Meningococcal B vaccine
Meningococcal B vaccine
Meningococcal B vaccine
Meningococcal B vaccine
Meningococcal B vaccine
Meningococcal B vaccine
Control
Meningococcal B vaccine with antipyretic
Countries
Argentina
Chile
Czechia
Hungary
Italy
Protocol Section
Identification Module
NCT ID
NCT00937521
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V72P16
Secondary IDs
ID
Type
Description
Link
2009-010106-11
Brief Title
Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
Official Title
A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants
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
Jul 2009
Primary Completion Date
Nov 2010Actual
Completion Date
Feb 2012Actual
First Submitted Date
Jun 29, 2009
First Submission Date that Met QC Criteria
Jul 10, 2009
First Posted Date
Jul 13, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 13, 2015
Results First Submitted that Met QC Criteria
Feb 13, 2015
Results First Posted Date
Mar 4, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 17, 2015
Last Update Posted Date
Apr 7, 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
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
Detailed Description
Not provided
Conditions Module
Conditions
Meningococcal Meningitis
Meningococcal Infections
Keywords
Immunogenicity
Meningitis
Antibody
Infants
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,507Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Other
Vaccine candidate formulation I
Biological: Meningococcal B vaccine
2
Other
Vaccine candidate formulation II
Biological: Meningococcal B vaccine
3
Other
Vaccine candidate formulation III
Biological: Meningococcal B vaccine
4
Other
Vaccine candidate formulation IV
Biological: Meningococcal B vaccine
5
Other
Vaccine candidate formulation V
Biological: Meningococcal B vaccine
6
Other
Vaccine candidate formulation VI
Biological: Meningococcal B vaccine
7
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Meningococcal B vaccine
Biological
Vaccine candidate formulation I
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
At baseline (pre-vaccination) and 30 days after the third vaccination.
Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
Day 1 to day 3 after first vaccination.
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:
One month after third vaccination.
One month after booster vaccination (Men B at 12 months of age).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements
Exclusion Criteria:
Any meningococcal B or C vaccine administration
Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
Any ascertained or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
History of severe allergic reaction after previous vaccinations
Recent significant acute or chronic infection
Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)
Any impairment/alteration of the immune system resulting from (for example):
Receipt of any immunosuppressive therapy at any time since birth
Receipt of immunostimulants at any time since birth
Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
Participation in another clinical trial
Family members and household members of research staff
Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
Esposito S, Prymula R, Zuccotti GV, Xie F, Barone M, Dull PM, Toneatto D. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). Hum Vaccin Immunother. 2014;10(7):2005-14. doi: 10.4161/hv.29218.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
FG001
B+½ OMV (Group II)
Periods
Title
Milestones
Reasons Not Completed
Overall Study - Prior to Booster Dose
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
Other
Control
Biological: Control
8
Other
Vaccine candidate formulation I with antipyretic
Biological: Meningococcal B vaccine with antipyretic
Meningococcal B vaccine
Biological
Vaccine candidate formulation II
2
Meningococcal B vaccine
Biological
Vaccine candidate formulation III
3
Meningococcal B vaccine
Biological
Vaccine candidate formulation IV
4
Meningococcal B vaccine
Biological
Vaccine candidate formulation V
5
Meningococcal B vaccine
Biological
Vaccine candidate formulation VI
6
Control
Biological
Control
7
Meningococcal B vaccine with antipyretic
Biological
Vaccine candidate formulation I with antipyretic
8
At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.
At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).
After the third and the booster vaccination.
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.
12 months (pre-fourth vaccination)
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.
1 month after fourth vaccination
Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.
At 13 months
Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).
1 month after booster
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).
Day 1 through day 7 after second and third vaccination.
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.
Day 1 through day 7 after each vaccination.
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.
Day 1 through day 7 after each vaccination.
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.
Day 1 through day 7 after each vaccination.
Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.
Overall study period.
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.
Day 1 through day 7 at 13 months age.
Comuna de Independencia
Santiago Metropolitan
Chile
Consultorio Manuel Bustos
Lo Cruzat 486, Quilicura
Santiago Metropolitan
Chile
Samostatna ordinace praktickeho lekare pro deti a dorost
O. Kubina 17
Boskovice
680 01
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Neklez 3
Brno
628 00
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Pernštýnská 127/l
Chlumec Nad Cidlinou
503 51
Czechia
Zdravotní středisko
Vaclavska 4186
Chomutov
430 03
Czechia
Nemocnice Decin, Detske oddělení
U Nemocnice 1
Děčín
405 01
Czechia
Fakulta vojenskeho zdravotnictvi UO
Trebešská 1575
Hradec Králové
50001
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Masarykova 389
Humpolec
396 01
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Ruských Legii 352
Jindřichův Hradec
377 01
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Hrnčířská 1401
Lipník Nad Bečvou
751 31
Czechia
Oblastni nemocnice Nachod, Destske oddělení
Purkyňova 446
Náchod
547 01
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
U Lékárny 306
Odolena Voda
250 70
Czechia
Prakticky lekar pro deti a dorost
Dvouletky 54
Ostrava
700 30
Czechia
KHS Ostrava, Protiepidemické oddělení
Na Bělidle 7
Ostrava
702 00
Czechia
Nemocnice Pardubice, Destske odděleni
Kyjevská 44
Pardubice
532 03
Czechia
Fakultni nemocnice Bory
E. Beneše 13
Plzeň
305 99
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Chrudimska 2a
Praha 3
130 00
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Kladenská 53
Praha 6
160 00
Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Velka Michalska 22
Znojmo
669 00
Czechia
Házi Gyermekorvosi szolgálat
Honvéd U.2.
Bordány
6795
Hungary
Medszolg 2000 Bt, 6723, Szeged, Dandár u.4
Ányos U.4.
Budapest
1031
Hungary
Erzsébet Kórház Gyermekosztály
Hódmezővásárhely
Dr. Imre József U.2.
Hungary
Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109
Szeged
Kossuth Lajos Sgt.109
Hungary
Dr. Bán Mariann és Társa Bt.
Kando Kalman U.1
Miskolc
3534
Hungary
Futurnest Kft
Selyemrét U.1.
Miskolc
3527
Hungary
Ped-Med Kft. , 3434 Mályi, Fő u.12.
Fő U.12.
Mályi
3434
Hungary
S.K. Sipka és Kovács Eü. Bt.
Csongrádi Sgt. 63.
Szeged
6723
Hungary
Oszila Kft. 6723, Szeged, Debreceni u.10-14.
Debreceni U.10-14.
Szeged
6723
Hungary
Győriné dr. Bari Eszter egyéni vállalkozó
Csongrád
Szentháromság Tér 10
Hungary
Vas Megyei Markusovszky Kórház, Gyermekosztály
Markusovszky U. 1-3
Szombathely
9700
Hungary
Dipartimento di Neonatologia e Terapia Intensiva Neonatale, "Ospedale dei Bambini", Presidio Ospedaliero dell'Azienda Ospedaliera Spedali Civili di Brescia
P.le Spedali Di Brescia,1
Brescia
25125
Italy
Dipartimento di Pediatria dell'Università degli Studi di Firenze
Viale Pieraccini N. 24
Firenze
50139
Italy
Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino
Via Consolare Valeria, 1
Messina
98125
Italy
Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano
Via Commenda, 9
Milano
20122
Italy
Pediatria dell'Ospedale Sacco di Milano
Via G.B.Grossi 74
Milano
20157
Italy
Dipartimento di Pediatria Azienda Ospedaliera di Padova
Via Giustiniani, 3
Padova
35128
Italy
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
FG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
FG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
FG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
FG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
FG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
FG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
FG000188 subjects
FG001190 subjects
FG002192 subjects
FG003188 subjects
FG004191 subjects
FG005188 subjects
FG006186 subjects
FG007184 subjects
Premature Withdrawal
FG0003 subjects
FG0015 subjects
FG0026 subjects
FG0031 subjects
FG0043 subjects
FG0051 subjects
FG0065 subjects
FG0071 subjects
COMPLETED
FG000185 subjects
FG001185 subjects
FG002186 subjects
FG003187 subjects
FG004188 subjects
FG005187 subjects
FG006181 subjects
FG007183 subjects
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0026 subjects
FG0031 subjects
FG0043 subjects
FG0051 subjects
FG0065 subjects
FG0071 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Inappropriate enrollment
FG0000 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Deviation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Booster Phase
Type
Comment
Milestone Data
STARTED
FG000155 subjects
FG001163 subjects
FG002169 subjects
FG003170 subjects
FG004168 subjects
FG005165 subjects
FG006165 subjects
FG007161 subjects
Premature Withdrawal
FG0003 subjects
FG0012 subjects
FG0025 subjects
FG0033 subjects
FG004
COMPLETED
FG000152 subjects
FG001161 subjects
FG002164 subjects
FG003167 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0025 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
BG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
BG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
BG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
BG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
BG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
BG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
BG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000188
BG001190
BG002192
BG003188
BG004191
BG005188
BG006186
BG007184
BG0081507
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
BG001190
BG002192
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00088
BG00191
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 Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
Analysis as per PP population.
Posted
Number
95% Confidence Interval
Percentages of Subjects
At baseline (pre-vaccination) and 30 days after the third vaccination.
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:
One month after third vaccination.
One month after booster vaccination (Men B at 12 months of age).
Per Protocol Primary and Booster populations.
Posted
Geometric Mean
95% Confidence Interval
Titers
At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Secondary
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.
As per PP population.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
Secondary
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).
As per PP population.
Posted
Geometric Mean
95% Confidence Interval
Ratios
After the third and the booster vaccination.
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
Secondary
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.
The analysis was done on the Per Protocol Booster population.
Posted
Number
95% Confidence Interval
Percentages of Subjects
12 months (pre-fourth vaccination)
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Secondary
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.
The analysis was done on the Per Protocol Booster population.
Posted
Number
95% Confidence Interval
Percentages of Subjects
1 month after fourth vaccination
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Secondary
Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.
The analysis was done on the Per Protocol population.
Posted
Geometric Mean
95% Confidence Interval
Titers
At 13 months
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Secondary
Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).
The analysis was done on the Per Protocol population.
Posted
Number
95% Confidence Interval
Percentage of Subjects
1 month after booster
ID
Title
Description
OG000
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Units
Counts
Participants
OG000
Secondary
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).
As per safety dataset.
Posted
Number
Subjects
Day 1 through day 7 after second and third vaccination.
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Secondary
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.
The analysis was performed on the safety population.
Posted
Number
Subjects
Day 1 through day 7 after each vaccination.
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Primary
Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
The analysis was done on the Safety Population.
Posted
Number
Subjects
Day 1 to day 3 after first vaccination.
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Secondary
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.
The analysis was performed on the safety population.
Posted
Number
Subjects
Day 1 through day 7 after each vaccination.
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Secondary
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.
The analysis was performed on the safety population.
Posted
Number
Subjects
Day 1 through day 7 after each vaccination.
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Secondary
Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.
The analysis was performed on the safety population.
Posted
Number
Subjects
Overall study period.
ID
Title
Description
OG000
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG002
B+1/4 OMV (Group III)
Secondary
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.
The analysis was performed on the safety population.
Posted
Number
Subjects
Day 1 through day 7 at 13 months age.
ID
Title
Description
OG000
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Units
Counts
Participants
OG000
Time Frame
All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal 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
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
16
184
181
184
EG001
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
20
184
183
184
EG002
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
12
189
186
189
EG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting..
20
187
183
187
EG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
13
187
180
187
EG005
PH2 B+OMV (Group VI)
SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
16
185
180
185
EG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
11
184
175
184
EG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.
15
183
175
183
EG008
B+OMV (Group I) Booster Phase
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
14
155
151
155
EG009
B+½ OMV (Group II) Booster Phase
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
7
163
159
163
EG010
B+1/4 OMV (Group III) Booster Phase
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
12
169
162
169
EG011
B (Group IV) Booster Phase
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
5
169
152
169
EG012
½ (B+OMV) (Group V) Booster Phase
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
15
168
154
168
EG013
PH2 B+OMV (Group VI) Booster Phase
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
9
165
156
165
EG014
MenC (Group VII) Booster Phase
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.
Group defined to include Booster Phase.
9
165
155
165
EG015
Par+B+OMV (Group VIII) Booster Phase
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
14
161
150
161
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cleft palate repair
Surgical and medical procedures
MedDRA 14.1
Non-systematic Assessment
EG0000 affected184 at risk
EG0010 affected184 at risk
EG0020 affected189 at risk
EG0030 affected187 at risk
EG0040 affected187 at risk
EG0050 affected185 at risk
EG0060 affected184 at risk
EG0070 affected183 at risk
EG0081 affected155 at risk
EG0090 affected163 at risk
EG0100 affected169 at risk
EG0110 affected169 at risk
EG0120 affected168 at risk
EG0130 affected165 at risk
EG0140 affected165 at risk
EG0150 affected161 at risk
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Non-systematic Assessment
EG0000 affected184 at risk
EG0010 affected184 at risk
EG0020 affected189 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
1month after 3rd vaccN=171,172,169,172,169,169,168
Title
Measurements
OG00010(8.59 to 12)
OG0017.81(6.69 to 9.12)
OG0025.74(4.92 to 6.71)
OG003
NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143
Title
Measurements
OG0001.6(1.43 to 1.8)
OG0011.28(1.15 to 1.43)
OG0021.23(1.1 to 1.37)
OG003
1month after boosterN=138,152,150,149,152,146,140
Title
Measurements
OG00020(16 to 24)
OG00118(15 to 22)
OG00211(9.07 to 13)
OG003
OG000171
OG001169
Title
Denominators
Categories
44/76-SL Strain - Baseline (N=166,166)
Title
Measurements
OG0001.25(1.14 to 1.37)
OG0011.18(1.08 to 1.3)
44/76-SL > 3rd (N=170,167)
Title
Measurements
OG000101(90 to 113)
OG001102(91 to 115)
44/76-SL Baseline booster (N=69,70)
Title
Measurements
OG0004.94(3.76 to 6.5)
OG0014.51(3.43 to 5.95)
44/76-SL > booster (N=65,63)
Title
Measurements
OG000120(95 to 150)
OG001136(107 to 172)
5/99 Strain - Baseline (N=162,157)
Title
Measurements
OG0001.18(1.07 to 1.3)
OG0011.07(0.97 to 1.18)
5/99 > 3rd (N=165,160)
Title
Measurements
OG000396(348 to 450)
OG001455(399 to 519)
5/99 Baseline booster (N=71,71)
Title
Measurements
OG00069(53 to 88)
OG001106(82 to 136)
5/99 > booser (N=73,76)
Title
Measurements
OG0001950(1573 to 2417)
OG0012182(1769 to 2691)
NZ98/254 Strain-Baseline (N=170,169)
Title
Measurements
OG0001.02(0.99 to 1.06)
OG0011.02(0.99 to 1.05)
NZ98/254 > 3rd (N=171,168)
Title
Measurements
OG00010(8.59 to 12)
OG0018.48(7.24 to 9.93)
NZ98/254 Baseline booster (N=141,143)
Title
Measurements
OG0001.6(1.43 to 1.8)
OG0011.48(1.32 to 1.66)
NZ98/254 > booster (N= 138, 140)
Title
Measurements
OG00020(16 to 24)
OG00120(17 to 25)
OG000162
OG001160
Title
Denominators
Categories
44/76-SL > 3rd (N=157,157)
Title
Measurements
OG00080(69 to 93)
OG00184(72 to 97)
44/76-SL > Booster (N=59,56)
Title
Measurements
OG00024(18 to 31)
OG00128(21 to 36)
5/99 > 3rd (N=152,142)
Title
Measurements
OG000345(292 to 408)
OG001417(350 to 497)
5/99 > Booster (N=68,68)
Title
Measurements
OG00027(21 to 35)
OG00120(16 to 25)
NZ98/254 > 3rd (N=162,160)
Title
Measurements
OG0009.65(8.19 to 11)
OG0018.69(7.36 to 10)
NZ98/254 > Booster (N=129,127)
Title
Measurements
OG00012(10 to 15)
OG00114(11 to 17)
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
OG000141
OG001155
OG002155
OG003150
OG004150
OG005153
OG006148
OG007143
Title
Denominators
Categories
44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70)
Title
Measurements
OG00055(43 to 67)
OG00158(46 to 69)
OG00266(54 to 77)
OG00363(51 to 74)
OG00445(33 to 57)
OG00544(32 to 56)
OG0064(1 to 11)
OG00747(35 to 59)
5/99 Pre-Boost(N=71,76,80,72,77,78,70,71)
Title
Measurements
OG00097(90 to 100)
OG001100(95 to 100)
OG002100(95 to 100)
OG003
NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143)
Title
Measurements
OG00012(7 to 19)
OG0016(3 to 11)
OG0025(2 to 10)
OG003
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
OG000138
OG001152
OG002150
OG003149
OG004152
OG005146
OG006147
OG007140
Title
Denominators
Categories
44/76-SL > Booster(N=65,73,70,75,76,71,63)
Title
Measurements
OG000100(94 to 100)
OG001100(95 to 100)
OG002100(95 to 100)
OG00397(91 to 100)
OG004100(95 to 100)
OG00599(92 to 100)
OG00684(74 to 91)
OG007100(94 to 100)
5/99 strain (N=73,77,79,72,76,74,76)
Title
Measurements
OG000100(95 to 100)
OG001100(95 to 100)
OG002100(95 to 100)
OG003
NZ98/254 (N=138,152,150,149,152,146,147,140)
Title
Measurements
OG00089(83 to 94)
OG00189(83 to 93)
OG00278(71 to 84)
OG003
Units
Counts
Participants
OG000138
OG001147
Title
Denominators
Categories
44/76-SL > Booster (N=65,75)
Title
Measurements
OG000120(95 to 150)
OG00112(10 to 16)
5/99 > Booster (N=73,69)
Title
Measurements
OG0001950(1573 to 2417)
OG00141(29 to 57)
NZ98/254 > Booster
Title
Measurements
OG00020(16 to 24)
OG0012.2(1.89 to 2.57)
147
Title
Denominators
Categories
44/76-SL > Booster (N=75)
Title
Measurements
OG00084(74 to 91)
5/99 > Booster (N=69)
Title
Measurements
OG00093(84 to 98)
NZ98/254 > Booster
Title
Measurements
OG00024(18 to 32)
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal multi-component recombinant, adsorbed vaccine (formulation V)and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
OG000182
OG001180
OG002186
OG003184
OG004182
OG005180
OG006177
OG007179
Title
Denominators
Categories
Second Vaccination (day1-3)
Title
Measurements
OG00090
OG00182
OG00276
OG00335
OG00474
OG00589
OG00630
OG00733
3rd vac d 1-3(N=181,179,185,183,181,180,177,179)
Title
Measurements
OG00055
OG00150
OG00236
OG003
First Vaccination (day1-7)
Title
Measurements
OG00094
OG00191
OG00274
OG003
Second Vaccination (day 1-7)
Title
Measurements
OG00090
OG00182
OG00277
OG003
3rd vac d 1-7(N=181,179,185,183,181,180,177,179)
Title
Measurements
OG00055
OG00153
OG00238
OG003
Booster d 1-7(N=155,162,169,168,168,165,164,159)
Title
Measurements
OG00081
OG00186
OG00264
OG003
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
OG000182
OG001180
OG002186
OG003184
OG004182
OG005180
OG006177
OG007179
Title
Denominators
Categories
Any Local (First Vacc)
Title
Measurements
OG000163
OG001155
OG002153
OG003123
OG004141
OG005157
OG006127
OG007137
Injection Site Tenderness (First Vacc)
Title
Measurements
OG000114
OG001116
OG002111
OG003
Injection Site Erythema (First Vacc)
Title
Measurements
OG000108
OG00199
OG00294
OG003
Injection Site Induration (First Vacc)
Title
Measurements
OG000101
OG00198
OG00285
OG003
Injection Site Swelling (First Vacc)
Title
Measurements
OG00058
OG00149
OG00255
OG003
Any Local (Second Vacc)
Title
Measurements
OG000156
OG001156
OG002155
OG003
Injection Site Tenderness (Second Vacc)
Title
Measurements
OG000121
OG001116
OG00297
OG003
Injection Site Erythema (Second Vacc)
Title
Measurements
OG000104
OG001114
OG002114
OG003
Injection Site Induration (Second Vacc)
Title
Measurements
OG000103
OG001105
OG00297
OG003
Injection Site Swelling (Second Vacc)
Title
Measurements
OG00064
OG00161
OG00254
OG003
Any Local (3rd N=181,179,185,183,181,180,177,179)
Title
Measurements
OG000151
OG001147
OG002141
OG003
Injection Site Tenderness (Third Vacc)
Title
Measurements
OG000102
OG00198
OG00278
OG003
Injection Site Erythema (Third Vacc)
Title
Measurements
OG000110
OG001106
OG002112
OG003
Injection Site Induration (Third Vacc)
Title
Measurements
OG00097
OG00192
OG00292
OG003
Injection Site Swelling (Third Vacc)
Title
Measurements
OG00056
OG00156
OG00246
OG003
Any Local BoostN=155,162,169,168,168,165,162,159
Title
Measurements
OG000131
OG001132
OG002149
OG003
Injection Site Tenderness (Booster Vacc)
Title
Measurements
OG000116
OG001107
OG002120
OG003
Injection Site Erythema (Booster Vacc)
Title
Measurements
OG00090
OG001101
OG002116
OG003
Injection Site Induration (Booster Vacc)
Title
Measurements
OG00073
OG00183
OG00295
OG003
Injection Site Swelling (Booster Vacc)
Title
Measurements
OG00055
OG00159
OG00269
OG003
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
OG000182
OG001180
OG002186
OG003184
OG004182
OG005180
OG006177
OG007179
Title
Denominators
Categories
Title
Measurements
OG00094
OG00191
OG00274
OG00324
OG00460
OG00576
OG00621
OG00746
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
OG000182
OG001180
OG002186
OG003184
OG004182
OG005180
OG006177
OG007179
Title
Denominators
Categories
Any Systemic (First Vacc)
Title
Measurements
OG000167
OG001173
OG002175
OG003152
OG004162
OG005171
OG006136
OG007150
Change Eat. Habits (First Vacc)
Title
Measurements
OG00076
OG00187
OG00284
OG003
Sleepiness (First Vacc)
Title
Measurements
OG000120
OG001131
OG002119
OG003
Vomiting (First Vacc)
Title
Measurements
OG00024
OG00118
OG00225
OG003
Diarrhea (First Vacc)
Title
Measurements
OG00057
OG00155
OG00254
OG003
Irritability (First Vacc)
Title
Measurements
OG000128
OG001124
OG002128
OG003
Unus Crying (First Vacc)
Title
Measurements
OG00095
OG001101
OG002105
OG003
Rash (First Vacc)
Title
Measurements
OG0006
OG0015
OG0025
OG003
Fever ( ≥ 38.5°C ) (First Vacc)
Title
Measurements
OG00094
OG00191
OG00274
OG003
Antipyr. Med. Used (First Vacc)
Title
Measurements
OG000102
OG00194
OG00292
OG003
Any Systemic (Second Vacc)
Title
Measurements
OG000168
OG001158
OG002166
OG003
Change Eat. Habits (Second Vacc)
Title
Measurements
OG00062
OG00155
OG00258
OG003
Sleepiness (Second Vacc)
Title
Measurements
OG000105
OG001100
OG002102
OG003
Vomiting (Second Vacc)
Title
Measurements
OG00018
OG00118
OG00214
OG003
Diarrhea (Second Vacc)
Title
Measurements
OG00043
OG00141
OG00247
OG003
Irritability (Second Vacc)
Title
Measurements
OG000130
OG001121
OG002124
OG003
Unus Crying (Second Vacc)
Title
Measurements
OG00090
OG00190
OG00284
OG003
Rash (Second Vacc)
Title
Measurements
OG0004
OG0019
OG0024
OG003
Fever ( ≥ 38.5°C ) (Second Vacc)
Title
Measurements
OG00090
OG00182
OG00277
OG003
Antipyr. Med. Used (Second Vacc)
Title
Measurements
OG000100
OG00194
OG00283
OG003
Any Syst (3rdN=181,179,185,182,181,180,177,179)
Title
Measurements
OG000146
OG001131
OG002132
OG003
Change Eat. Habits (Third Vacc)
Title
Measurements
OG00049
OG00150
OG00242
OG003
Sleepiness (Third Vacc)
Title
Measurements
OG00075
OG00167
OG00282
OG003
Vomiting (Third Vacc)
Title
Measurements
OG0008
OG00118
OG00215
OG003
Diarrhea (Third Vacc)
Title
Measurements
OG00033
OG00129
OG00239
OG003
Irritability (Third Vacc)
Title
Measurements
OG000115
OG00197
OG00293
OG003
Unus Crying (Third Vacc)
Title
Measurements
OG00076
OG00182
OG00262
OG003
Rash (Third Vacc)
Title
Measurements
OG0001
OG0016
OG0024
OG003
Fever ( ≥ 38.5°C ) (Third Vacc)
Title
Measurements
OG00055
OG00153
OG00238
OG003
Antipyr. Med. Used (Third Vacc)
Title
Measurements
OG00066
OG00160
OG00251
OG003
Any Syst(BoosterN=155,162,169,169,168,165,164,159)
Title
Measurements
OG000143
OG001144
OG002139
OG003
Change Eat. Habits (Booster Vacc)
Title
Measurements
OG00074
OG00177
OG00279
OG003
Sleepiness (Booster Vacc)
Title
Measurements
OG00076
OG00190
OG00290
OG003
Vomiting (Booster Vacc)
Title
Measurements
OG0006
OG00111
OG0027
OG003
Diarrhea (Booster Vacc)
Title
Measurements
OG00030
OG00134
OG00236
OG003
Irritability (Booster Vacc)
Title
Measurements
OG000116
OG001111
OG002112
OG003
Unus Crying (Booster Vacc)
Title
Measurements
OG00074
OG00164
OG00269
OG003
Rash (Booster Vacc)
Title
Measurements
OG0005
OG0015
OG0028
OG003
Fever ( ≥ 38.5°C ) (Booster Vacc)
Title
Measurements
OG00081
OG00186
OG00264
OG003
Antipyr. Med. Used (Booster Vacc)
Title
Measurements
OG00084
OG00182
OG00283
OG003
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
OG000184
OG001184
OG002189
OG003187
OG004187
OG005185
OG006184
OG007183
Title
Denominators
Categories
Any AE (Day 1 to 7) (First Vacc)
Title
Measurements
OG00055
OG00152
OG00251
OG00333
OG00435
OG00539
OG00627
OG00742
At least Possibly related AE (First Vacc)
Title
Measurements
OG00048
OG00148
OG00243
OG003
Any SAE (First Vacc)
Title
Measurements
OG0000
OG0011
OG0020
OG003
Any AE D1-7 2nd N=182,181,186,184,183,180,178,180
Title
Measurements
OG00055
OG00153
OG00250
OG003
At least Possibly related AE (Second Vaccination)
Title
Measurements
OG00049
OG00145
OG00245
OG003
Any SAE (Second Vacc)
Title
Measurements
OG0001
OG0010
OG0021
OG003
Any AE D1-7 3rd N=182,181,186,184,182,180,177,179
Title
Measurements
OG00040
OG00159
OG00249
OG003
At least Possibly related AE (Third Vacc)
Title
Measurements
OG00034
OG00152
OG00245
OG003
Any SAE (Third Vacc)
Title
Measurements
OG0002
OG0010
OG0022
OG003
Any AE D 1-7Boos N=155,163,169,169,168,165,165,161
Title
Measurements
OG00035
OG00146
OG00256
OG003
At least Possibly related AE (Booster Vacc)
Title
Measurements
OG00028
OG00141
OG00248
OG003
Any SAE (Booster Vacc)
Title
Measurements
OG0000
OG0011
OG0022
OG003
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG003
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG004
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG005
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
OG006
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
OG007
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Units
Counts
Participants
OG000184
OG001184
OG002189
OG003187
OG004187
OG005185
OG006184
OG007183
Title
Denominators
Categories
AE Leading to Premature Withdrawal-Primary Vacc
Title
Measurements
OG0000
OG0012
OG0022
OG0030
OG0040
OG0051
OG0062
OG0071
Treatment Emergent SAEs - Primary Vacc
Title
Measurements
OG00016
OG00120
OG00212
OG003
Tr E SAE Boost (N=155,163,169,169,168,165,165,161)