Back to resultsSafety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Primary Purpose
Meningococcal Infections
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rMenB+OMV NZ
combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine
Pneumococcal vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Infections focused on measuring Meningococcal disease,, Neisseria meningitidis serogroup B,, Prevention,, Vaccination,, Infants
Eligibility Criteria
Inclusion Criteria:
- Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
- For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.
Exclusion Criteria:
- History of any meningococcal B or C vaccine administration;
- prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
- Previous ascertained or suspected disease caused by N. meningitidis;
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
- Antibiotics within 6 days prior to enrollment;
- Any serious chronic or progressive disease;
- Known or suspected impairment or alteration of the immune system;
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Sites / Locations
- Novartis Investigational Site Nr. 59
- Study Investigational Site Nr. 60
- Novartis Investigational Site Nr. 57
- Novartis Investigational Site Nr. 56
- Novartis Investigational Site Nr. 55
- Novartis Investigational Site Nr. 58
- Novartis Investigational Site Nr. 95
- Novartis Investigational Site Nr. 96
- Novartis Investigational Site Nr. 93
- Novartis Investigational Site Nr. 94
- Novartis Investigational Site Nr. 68
- Novartis Investigational Site Nr. 65
- Novartis Investigational Site Nr. 62
- Novartis Investigational Site Nr. 64
- Novartis Investigational Site Nr. 66
- Novartis Investigational Site Nr. 69
- Novartis Investigational Site Nr. 71
- Novartis Investigational Site Nr. 73
- Novartis Investigational Site Nr. 75
- Novartis Investigational Site Nr. 81
- Novartis Investigational Site Nr. 79
- Novartis Investigational Site Nr. 80
- Novartis Investigational Site Nr. 78
- Novartis Investigational Site Nr. 82
- Novartis Investigational Site Nr. 83
- Novartis Investigational Site Nr. 85
- Novartis Investigational Site Nr. 61
- Novartis Investigational Site Nr. 67
- Novartis Investigational Site Nr. 86
- Novartis Investigational Site Nr. 88
- Novartis Investigational Site Nr. 89
- Novartis Investigational Site Nr. 87
- Novartis Investigational Site Nr. 90
- Novartis Investigational Site Nr. 70
- Novartis Investigational Site Nr. 72
- Novartis Investigational Site Nr. 5
- Novartis Investigational Site Nr. 52
- Novartis Investigational Site Nr. 6
- Novartis Investigational Site Nr. 7
- Novartis Investigational Site Nr. 9
- Novartis Investigational Site Nr. 46
- Novartis Investigational Site Nr. 49
- Novartis Investigational Site Nr. 11
- Novartis Investigational Site Nr. 10
- Novartis Investigational Site Nr. 12
- Novartis Investigational Site Nr. 48
- Novartis Investigational Site Nr. 25
- Novartis Investigational Site Nr. 21
- Novartis Investigational Site 14
- Novartis Investigational Site Nr. 17
- Novartis Investigational Site Nr. 24
- Novartis Investigational Site Nr. 15
- Novartis Investigational Site Nr. 18
- Novartis Investigational Site Nr. 19
- Novartis Investigational Site Nr. 16
- Novartis Investigational Site Nr. 23
- Novartis Investigational Site Nr. 1
- Novartis Investigational Site 3
- Novartis Investigational Site Nr. 4
- Novartis Investigational Site Nr. 2
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
B+R246
B246_R357
B+R234
R234
Arm Description
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations.
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age.
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
Outcomes
Primary Outcome Measures
Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants.
The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).
The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains.
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357).
Secondary Outcome Measures
Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.
Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine
Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.
Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.
Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.
Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.
Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.
Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.
Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline.
Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00721396
Brief Title
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Official Title
A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV NZ when given concomitantly with routine infant vaccines was non-inferior to that of rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine without rMenB+OMV NZ.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Infections
Keywords
Meningococcal disease,, Neisseria meningitidis serogroup B,, Prevention,, Vaccination,, Infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1885 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B+R246
Arm Type
Experimental
Arm Description
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations.
Arm Title
B246_R357
Arm Type
Experimental
Arm Description
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age.
Arm Title
B+R234
Arm Type
Experimental
Arm Description
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.
Arm Title
R234
Arm Type
Active Comparator
Arm Description
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
Intervention Type
Biological
Intervention Name(s)
rMenB+OMV NZ
Intervention Type
Biological
Intervention Name(s)
combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine
Other Intervention Name(s)
Infanrix Hexa
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine
Other Intervention Name(s)
Prevenar
Primary Outcome Measure Information:
Title
Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
Description
The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants.
The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).
The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains.
Time Frame
One month after third Men B vaccination
Title
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Description
Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357).
Time Frame
10 months (groups 1 and 2); 8 months (groups 3 and 4)
Secondary Outcome Measure Information:
Title
Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
Description
The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.
Time Frame
One month after 3rd Men B vaccination
Title
Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine
Description
Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.
Time Frame
One month after 3rd vaccination
Title
Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
Description
The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.
Time Frame
One month after third Men B vaccination
Title
Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
Description
The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.
Time Frame
one month after third Men B vaccination
Title
Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
Description
The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.
Time Frame
One month after third Men B vaccination
Title
Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
Description
The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.
Time Frame
One month after third Men B vaccination
Title
Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.
Description
Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline.
Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies.
Time Frame
1 month after 3rd vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.
Exclusion Criteria:
History of any meningococcal B or C vaccine administration;
prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
Previous ascertained or suspected disease caused by N. meningitidis;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
Antibiotics within 6 days prior to enrollment;
Any serious chronic or progressive disease;
Known or suspected impairment or alteration of the immune system;
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigational Site Nr. 59
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Study Investigational Site Nr. 60
City
Brussels
State/Province
Brussels-Capital Region
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novartis Investigational Site Nr. 57
City
Brussels
State/Province
Brussels-Capital Region
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigational Site Nr. 56
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Novartis Investigational Site Nr. 55
City
Antwerp
ZIP/Postal Code
2018
Country
Belgium
Facility Name
Novartis Investigational Site Nr. 58
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Novartis Investigational Site Nr. 95
City
Červený Kostelec
State/Province
Hradec Králové
ZIP/Postal Code
549 41
Country
Czech Republic
Facility Name
Novartis Investigational Site Nr. 96
City
Jindřichův Hradec
State/Province
South Bohemian
ZIP/Postal Code
377 01
Country
Czech Republic
Facility Name
Novartis Investigational Site Nr. 93
City
Hradec Králové
ZIP/Postal Code
500 00
Country
Czech Republic
Facility Name
Novartis Investigational Site Nr. 94
City
Pardubice
ZIP/Postal Code
530 01
Country
Czech Republic
Facility Name
Novartis Investigational Site Nr. 68
City
Bad Saulgau
State/Province
Baden-Württemberg
ZIP/Postal Code
88348
Country
Germany
Facility Name
Novartis Investigational Site Nr. 65
City
Bretten
State/Province
Baden-Württemberg
ZIP/Postal Code
75015
Country
Germany
Facility Name
Novartis Investigational Site Nr. 62
City
Kehl
State/Province
Baden-Württemberg
ZIP/Postal Code
77694
Country
Germany
Facility Name
Novartis Investigational Site Nr. 64
City
Oberstenfeld
State/Province
Baden-Württemberg
ZIP/Postal Code
71720
Country
Germany
Facility Name
Novartis Investigational Site Nr. 66
City
Welzheim
State/Province
Baden-Württemberg
ZIP/Postal Code
73642
Country
Germany
Facility Name
Novartis Investigational Site Nr. 69
City
Aschaffenburg
State/Province
Bavaria
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novartis Investigational Site Nr. 71
City
Bremerhaven
State/Province
Bremen
ZIP/Postal Code
27568
Country
Germany
Facility Name
Novartis Investigational Site Nr. 73
City
Baunatal
State/Province
Hesse
ZIP/Postal Code
34225
Country
Germany
Facility Name
Novartis Investigational Site Nr. 75
City
Bramsche
State/Province
Lower Saxony
ZIP/Postal Code
49565
Country
Germany
Facility Name
Novartis Investigational Site Nr. 81
City
Bochum
State/Province
North Rhine-Westphalia
ZIP/Postal Code
44866
Country
Germany
Facility Name
Novartis Investigational Site Nr. 79
City
Heiligenhaus
State/Province
North Rhine-Westphalia
ZIP/Postal Code
42579
Country
Germany
Facility Name
Novartis Investigational Site Nr. 80
City
Kleve Materborn
State/Province
North Rhine-Westphalia
ZIP/Postal Code
47533
Country
Germany
Facility Name
Novartis Investigational Site Nr. 78
City
Monchengladbach
State/Province
North Rhine-Westphalia
ZIP/Postal Code
41236
Country
Germany
Facility Name
Novartis Investigational Site Nr. 82
City
Munster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48163
Country
Germany
Facility Name
Novartis Investigational Site Nr. 83
City
Warburg
State/Province
North Rhine-Westphalia
ZIP/Postal Code
34414
Country
Germany
Facility Name
Novartis Investigational Site Nr. 85
City
Bielefeld
State/Province
North-Rhine Westphalia
ZIP/Postal Code
33617
Country
Germany
Facility Name
Novartis Investigational Site Nr. 61
City
Mainz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigational Site Nr. 67
City
Schweigen
State/Province
Rhineland-Palatinate
ZIP/Postal Code
76889
Country
Germany
Facility Name
Novartis Investigational Site Nr. 86
City
Wanzleben
State/Province
Saxony-Anhalt
ZIP/Postal Code
39164
Country
Germany
Facility Name
Novartis Investigational Site Nr. 88
City
Itzenhoe
State/Province
Schleswig-Holstein
ZIP/Postal Code
25524
Country
Germany
Facility Name
Novartis Investigational Site Nr. 89
City
Itzenhoe
State/Province
Schleswig-Holstein
ZIP/Postal Code
25524
Country
Germany
Facility Name
Novartis Investigational Site Nr. 87
City
Stockelsdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
23617
Country
Germany
Facility Name
Novartis Investigational Site Nr. 90
City
Erfurt
State/Province
Thuringia
ZIP/Postal Code
99086
Country
Germany
Facility Name
Novartis Investigational Site Nr. 70
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Novartis Investigational Site Nr. 72
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Novartis Investigational Site Nr. 5
City
Milano
State/Province
Lombardy
ZIP/Postal Code
20122
Country
Italy
Facility Name
Novartis Investigational Site Nr. 52
City
Milano
State/Province
Lombardy
ZIP/Postal Code
20157
Country
Italy
Facility Name
Novartis Investigational Site Nr. 6
City
Novara
State/Province
Piedmont
ZIP/Postal Code
28100
Country
Italy
Facility Name
Novartis Investigational Site Nr. 7
City
Firenze
State/Province
Tuscany
ZIP/Postal Code
50139
Country
Italy
Facility Name
Novartis Investigational Site Nr. 9
City
Padova
State/Province
Veneto
ZIP/Postal Code
35100
Country
Italy
Facility Name
Novartis Investigational Site Nr. 46
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novartis Investigational Site Nr. 49
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Novartis Investigational Site Nr. 11
City
Almassora
State/Province
Castellón
ZIP/Postal Code
12550
Country
Spain
Facility Name
Novartis Investigational Site Nr. 10
City
Castellon de la Plana
State/Province
Castellón
ZIP/Postal Code
12006
Country
Spain
Facility Name
Novartis Investigational Site Nr. 12
City
Vall D'Uixo
State/Province
Castelló
ZIP/Postal Code
12600
Country
Spain
Facility Name
Novartis Investigational Site Nr. 48
City
Vigo Pontevedra
State/Province
Pontevedra
ZIP/Postal Code
36204
Country
Spain
Facility Name
Novartis Investigational Site Nr. 25
City
Catarroja
State/Province
Valencia
ZIP/Postal Code
46470
Country
Spain
Facility Name
Novartis Investigational Site Nr. 21
City
La Eliana
State/Province
Valencia
ZIP/Postal Code
46183
Country
Spain
Facility Name
Novartis Investigational Site 14
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46500
Country
Spain
Facility Name
Novartis Investigational Site Nr. 17
City
Valencia
ZIP/Postal Code
46011
Country
Spain
Facility Name
Novartis Investigational Site Nr. 24
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Novartis Investigational Site Nr. 15
City
Valencia
ZIP/Postal Code
46021
Country
Spain
Facility Name
Novartis Investigational Site Nr. 18
City
Valencia
ZIP/Postal Code
46022
Country
Spain
Facility Name
Novartis Investigational Site Nr. 19
City
Valencia
ZIP/Postal Code
46022
Country
Spain
Facility Name
Novartis Investigational Site Nr. 16
City
Valencia
ZIP/Postal Code
46024
Country
Spain
Facility Name
Novartis Investigational Site Nr. 23
City
Valencia
ZIP/Postal Code
46200
Country
Spain
Facility Name
Novartis Investigational Site Nr. 1
City
Oxford
State/Province
South East England
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Novartis Investigational Site 3
City
Bristol
State/Province
South West England
ZIP/Postal Code
BS8 1TH
Country
United Kingdom
Facility Name
Novartis Investigational Site Nr. 4
City
Exeter
State/Province
South West England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Novartis Investigational Site Nr. 2
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31110098
Citation
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.
Results Reference
derived
PubMed Identifier
22318278
Citation
Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, Kieninger D, Prymula R, Dull P, Ypma E, Toneatto D, Kimura A, Pollard AJ; European MenB Vaccine Study Group. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012 Feb 8;307(6):573-82. doi: 10.1001/jama.2012.85.
Results Reference
derived
Learn more about this trial
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
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