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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B+R246 | Experimental | Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations. |
|
| B246_R357 | Experimental | 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. |
|
| B+R234 | Experimental | Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations. |
|
| R234 | Active Comparator | Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rMenB+OMV NZ | Biological |
| ||
| combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month after third Men B vaccination |
| 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). | 10 months (groups 1 and 2); 8 months (groups 3 and 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site Nr. 59 | Edegem | Antwerpen | 2650 | Belgium | ||
| Novartis Investigational Site Nr. 55 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31110098 | Derived | 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. | |
| 22318278 |
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All subjects enrolled were included in the trial.
Subjects were recruited from 4 centers in UK, 5 centers in Italy, 16 centers in Spain, 6 centers in Belgium, 25 centers in Germany and 4 centers in Czech Republic
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| ID | Title | Description |
|---|---|---|
| FG000 | B+R246 | Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations |
| FG001 | B246_R357 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
|
|
| Pneumococcal vaccine | Biological |
|
|
| One month after 3rd Men B vaccination |
| 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. | One month after 3rd vaccination |
| 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. | One month after third Men B vaccination |
| 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. | one month after third Men B vaccination |
| 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. | One month after third Men B vaccination |
| 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. | One month after third Men B vaccination |
| 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. | 1 month after 3rd vaccination |
| Antwerp |
| Antwerp |
| 2018 |
| Belgium |
| Study Investigational Site Nr. 60 | Brussels | Brussels Capital | 1090 | Belgium |
| Novartis Investigational Site Nr. 57 | Brussels | Brussels Capital | 1200 | Belgium |
| Novartis Investigational Site Nr. 56 | Hasselt | Limburg | 3500 | Belgium |
| Novartis Investigational Site Nr. 58 | Namur | Namur | 5000 | Belgium |
| Novartis Investigational Site Nr. 95 | Červený Kostelec | Hradec Králové | 549 41 | Czechia |
| Novartis Investigational Site Nr. 93 | Hradec Králové | Hradec Králové | 500 00 | Czechia |
| Novartis Investigational Site Nr. 94 | Pardubice | Pardubice | 530 01 | Czechia |
| Novartis Investigational Site Nr. 96 | Jindřichův Hradec | South Bohemian | 377 01 | Czechia |
| Novartis Investigational Site Nr. 68 | Bad Saulgau | Baden-Wurttemberg | 88348 | Germany |
| Novartis Investigational Site Nr. 65 | Bretten | Baden-Wurttemberg | 75015 | Germany |
| Novartis Investigational Site Nr. 62 | Kehl | Baden-Wurttemberg | 77694 | Germany |
| Novartis Investigational Site Nr. 64 | Oberstenfeld | Baden-Wurttemberg | 71720 | Germany |
| Novartis Investigational Site Nr. 66 | Welzheim | Baden-Wurttemberg | 73642 | Germany |
| Novartis Investigational Site Nr. 69 | Aschaffenburg | Bavaria | 63739 | Germany |
| Novartis Investigational Site Nr. 72 | Hamburg | Free and Hanseatic City of Hamburg | 22415 | Germany |
| Novartis Investigational Site Nr. 71 | Bremerhaven | Free Hanseatic City of Bremen | 27568 | Germany |
| Novartis Investigational Site Nr. 73 | Baunatal | Hesse | 34225 | Germany |
| Novartis Investigational Site Nr. 75 | Bramsche | Lower Saxony | 49565 | Germany |
| Novartis Investigational Site Nr. 85 | Bielefeld | North Rhine-Westphalia | 33617 | Germany |
| Novartis Investigational Site Nr. 81 | Bochum | North Rhine-Westphalia | 44866 | Germany |
| Novartis Investigational Site Nr. 79 | Heiligenhaus | North Rhine-Westphalia | 42579 | Germany |
| Novartis Investigational Site Nr. 80 | Kleve Materborn | North Rhine-Westphalia | 47533 | Germany |
| Novartis Investigational Site Nr. 78 | Mönchengladbach | North Rhine-Westphalia | 41236 | Germany |
| Novartis Investigational Site Nr. 82 | Münster | North Rhine-Westphalia | 48163 | Germany |
| Novartis Investigational Site Nr. 83 | Warburg | North Rhine-Westphalia | 34414 | Germany |
| Novartis Investigational Site Nr. 61 | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Novartis Investigational Site Nr. 67 | Schweigen | Rhineland-Palatinate | 76889 | Germany |
| Novartis Investigational Site Nr. 86 | Wanzleben | Saxony-Anhalt | 39164 | Germany |
| Novartis Investigational Site Nr. 88 | Itzenhoe | Schleswig-Holstein | 25524 | Germany |
| Novartis Investigational Site Nr. 89 | Itzenhoe | Schleswig-Holstein | 25524 | Germany |
| Novartis Investigational Site Nr. 87 | Stockelsdorf | Schleswig-Holstein | 23617 | Germany |
| Novartis Investigational Site Nr. 70 | Berlin | State of Berlin | 13125 | Germany |
| Novartis Investigational Site Nr. 90 | Erfurt | Thuringia | 99086 | Germany |
| Novartis Investigational Site Nr. 5 | Milan | Lombardy | 20122 | Italy |
| Novartis Investigational Site Nr. 52 | Milan | Lombardy | 20157 | Italy |
| Novartis Investigational Site Nr. 6 | Novara | Piedmont | 28100 | Italy |
| Novartis Investigational Site Nr. 7 | Florence | Tuscany | 50139 | Italy |
| Novartis Investigational Site Nr. 9 | Padova | Veneto | 35100 | Italy |
| Novartis Investigational Site Nr. 46 | Santiago de Compostela | A Coruña | 15706 | Spain |
| Novartis Investigational Site Nr. 11 | Almassora | Castellón | 12550 | Spain |
| Novartis Investigational Site Nr. 10 | Castellon | Castellón | 12006 | Spain |
| Novartis Investigational Site Nr. 12 | Vall D'Uixo | Castelló | 12600 | Spain |
| Novartis Investigational Site Nr. 48 | Vigo Pontevedra | Pontevedra | 36204 | Spain |
| Novartis Investigational Site Nr. 49 | Oviedo | Principality of Asturias | 33006 | Spain |
| Novartis Investigational Site Nr. 25 | Catarroja | Valencia | 46470 | Spain |
| Novartis Investigational Site Nr. 21 | L'Eliana | Valencia | 46183 | Spain |
| Novartis Investigational Site 14 | Sagunto | Valencia | 46500 | Spain |
| Novartis Investigational Site Nr. 17 | Valencia | Valencia | 46011 | Spain |
| Novartis Investigational Site Nr. 24 | Valencia | Valencia | 46017 | Spain |
| Novartis Investigational Site Nr. 15 | Valencia | Valencia | 46021 | Spain |
| Novartis Investigational Site Nr. 18 | Valencia | Valencia | 46022 | Spain |
| Novartis Investigational Site Nr. 19 | Valencia | Valencia | 46022 | Spain |
| Novartis Investigational Site Nr. 16 | Valencia | Valencia | 46024 | Spain |
| Novartis Investigational Site Nr. 23 | Valencia | Valencia | 46200 | Spain |
| Novartis Investigational Site Nr. 2 | London | London | SW17 0RE | United Kingdom |
| Novartis Investigational Site Nr. 1 | Oxford | South East England | OX3 7LE | United Kingdom |
| Novartis Investigational Site 3 | Bristol | South West England | BS8 1TH | United Kingdom |
| Novartis Investigational Site Nr. 4 | Exeter | South West England | EX2 5DW | United Kingdom |
| 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. |
| FG002 | B+R234 | Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations |
| FG003 | R234 | Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | B+R246 | Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations |
| BG001 | B246_R357 | 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 |
| BG002 | B+R234 | Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations |
| BG003 | R234 | Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | days |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | 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. | The analysis was done on the Modified Intention to Treat (MIIT) population, ie, enrolled subjects who actually received a study vaccination and provided at least one evaluable serum sample after baseline. | Posted | Number | 95% Confidence Interval | Percentages of subjects | One month after third Men B vaccination |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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). | All subjects receiving at least one injection and providing post-baseline safety data (Safety Set). | Posted | Number | Number of subjects | 10 months (groups 1 and 2); 8 months (groups 3 and 4) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Analysis was done on the per-protocol population i.e all subjects in the MITT population who received all the relevant doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to analysis. | Posted | Number | 95% Confidence Interval | Percentages of subjects | One month after 3rd Men B vaccination |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis: Per Protocol (PP) Population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | One month after 3rd vaccination |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | PP Population | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month after third Men B vaccination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PP Population | Posted | Geometric Mean | 95% Confidence Interval | Ratio | one month after third Men B vaccination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PP Population | Posted | Number | 95% Confidence Interval | Percentages of subjects | One month after third Men B vaccination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PP Population | Posted | Number | 95% Confidence Interval | Percentages of subjects | One month after third Men B vaccination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month after 3rd vaccination |
|
|
Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 [625], B246_R357 [627], B+R234 [318], R234 [312]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 [2], B246_R357 [1]).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B+R246 | Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations | 63 | 625 | 620 | 625 | ||
| EG001 | B246_R357 | 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 | 57 | 627 | 623 | 627 | ||
| EG002 | B+R234 | Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations | 19 | 318 | 316 | 318 | ||
| EG003 | R234 | Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. | 19 | 312 | 305 | 312 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadentitis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Congenital musculoskeletal anomaly | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Craniosynostosis | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Talipes | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Urachal abnormality | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Retinal dystrophy | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Developmental delay | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gatroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gatroenteritis adenovirus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gatroenteritis rotavirus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal bacteremia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Accidental exposure | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Blood alkaline phosphatase abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Hemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Crying | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotonic-hyporesponsive episode | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Petit mal epilepsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Aponetic attack | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Prophylaxis | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Kawasaki's disease | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Injection Site Induration | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Crying | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| D022242 | Pneumococcal Vaccines |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
Not provided
Not provided
| Male |
|
| Post vaccination (44/76-SL)N=550,561,283,265 |
|
| Baseline (5/99 strain)N=580,577,294,289 |
|
| Post vaccination (5/99 strain)N=551,554,285,245 |
|
| Baseline(NZ98/254 strain)N=582,583,298,292 |
|
| Post vaccination(NZ98/254 strain)N=555,559,284,269 |
|
| OG003 | R234 | Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. |
|
|
| Counts |
|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. |
|
|
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. |
|
|
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|
| R234 |
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. |
|
|
| Counts |
|---|
| Participants |
|
|
|