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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2007-007781-38 |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rMenB Lot1 | Experimental | Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
|
| rMenB Lot2 | Experimental | Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
|
| rMenB Lot3 | Experimental | Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
|
| Routine | Active Comparator | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
|
| MenC + Routine | Active Comparator | Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1) | Biological | One dose of rMenB Lot concomitantly with the routinely administered infant vaccines |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs). | one month after the third vaccination |
| The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported. | one month after the third vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination. | 1 month after the third vaccination |
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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 |
|---|---|---|---|---|---|---|
| Grässl | Hall in Tirol | 6060 | Austria | |||
| Häckel |
| 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. | |
| 23324563 |
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All enrolled subjects were included in the trial.
16 sites in Finland, 28 sites in the Czech Republic, 13 sites in Germany, 6 sites in Austria, 7 sites in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | rMenB Lot1 | Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| FG001 | rMenB Lot2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2) | Biological | One dose of rMenB concomitantly with the routinely administered infant vaccines |
|
| Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3) | Biological | One dose of rMenB concomitantly with the routinely administered infant vaccines |
|
| Infanrix Hexa | Biological | Routine vaccination |
|
| Menjugate | Biological | One dose of the routinely administered infant vaccines + MenC vaccine |
|
| Prevenar | Biological | Routine vaccination |
|
| Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ. | 1 Month after the third vaccination |
| Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination. | 1 month after third vaccination |
| Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination. | 1 month after third vaccination |
| Percentages of Subjects With Antibody Response Against the Routine Antigens | The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL. HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml | 1 Month after third vaccination |
| Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid). | 5 months |
| Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age. | 1 Month after third vaccination |
| Percentage of Subjects With hSBA Titers ≥1:8 | Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains. | 1 month after third vaccination |
| Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events. | upto 7 days after any vaccination |
| Kirchdorf |
| 4560 |
| Austria |
| Prieler | Neufeld A.d. Leitha | 2491 | Austria |
| Maurer | Salzburg | 5020 | Austria |
| Sommer | Vienna | 1230 | Austria |
| Angermayr | Wels | 4600 | Austria |
| Site 27 | Boskovice | 680 01 | Czechia |
| Site 19 | Brno | 628 00 | Czechia |
| Site 22 | Chomutov | 430 03 | Czechia |
| Site11 | Červený Kostelec | 54941 | Czechia |
| Site 14 | Děčín | 405 01 | Czechia |
| Site 12 | Havlíčkův Brod | 580 22 | Czechia |
| Site 8 | Hradec Králové | 500 01 | Czechia |
| Site 9 | Hradec Králové | 500 05 | Czechia |
| Site 28 | Hranice I-mesto | 753 01 | Czechia |
| Site 13 | Humpolec | 396 01 | Czechia |
| Site 15 | Jindřichův Hradec | 377 01 | Czechia |
| Site 25 | Kladno | 272 00 | Czechia |
| Site 21 | Kolín | 280 02 | Czechia |
| Site 10 | Liberec | 460 15 | Czechia |
| Site 24 | Litoměřice | 412 01 | Czechia |
| Site 17 | Ostrava | 702 00 | Czechia |
| Site 18 | Ostrava-Poruba | 708 68 | Czechia |
| Site 7 | Pardubice | 532 03 | Czechia |
| Site 16 | Pilsen | 305 99 | Czechia |
| Site 2 | Prague | 130 00 | Czechia |
| Site 3 | Prague | 140 00 | Czechia |
| Site 5 | Prague | 16000 | Czechia |
| Site 6 | Prague | 19000 | Czechia |
| Site 26 | Rumburk | 408 01 | Czechia |
| Site 23 | Ústí nad Labem | 400 01 | Czechia |
| Site 20 | Znojmo | 669 00 | Czechia |
| Site 30 | Espoo | 02230 | Finland |
| Site 31 | Helsinki | 00100 | Finland |
| Site 32 | Helsinki | 00930 | Finland |
| Site 34 | Jarvenpaa | 04400 | Finland |
| Site 35 | Kokkola | 67100 | Finland |
| Site 45 | Kotka | 48600 | Finland |
| Site 46 | Kuopio | 70211 | Finland |
| Site 47 | Lahti | 15140 | Finland |
| Site 49 | Oulu | 90220 | Finland |
| Site 50 | Pori | 28100 | Finland |
| Site 51 | Seinäjoki | 60100 | Finland |
| Site 52 | Tampere | 33100 | Finland |
| Site 53 | Turku | 20520 | Finland |
| Site 33 | Vantaa | 01300 | Finland |
| Site 48 | Vantaa | 01600 | Finland |
| Site 99 | Detmold | 32756 | Germany |
| Site 92 | Espelkamp | 32339 | Germany |
| Site 95 | Freising | 85354 | Germany |
| Site 64 | Fulda | 36037 | Germany |
| Site 58 | Lauffen am Neckar | 74348 | Germany |
| Site 57 | Marbach A. N. | 74348 | Germany |
| Site 97 | München | 81377 | Germany |
| Site 96 | München | 81475 | Germany |
| Site 91 | Műnchen | 81737 | Germany |
| Site 81 | Porta Westfalica | 32457 | Germany |
| Site 65 | Schwieberdingen | 71701 | Germany |
| Site 94 | Weilheim | 82362 | Germany |
| Dipartimento di Scienze della Salute | Genova | 16132 | Italy |
| Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino | Messina | 98122 | Italy |
| Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia | Milan | 20122 | Italy |
| Pediatria dell' Ospedale Sacco | Milan | 20157 | Italy |
| Ospedale Maggiore della Carita'-Clinica Pediatrica | Novara | 28100 | Italy |
| Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari | Sassari | 07100 | Italy |
| ASL/TA | Taranto | 74100 | Italy |
| Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. doi: 10.1016/S0140-6736(12)61961-8. |
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
| FG002 | rMenB Lot3 | Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| FG003 | Routine | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
| FG004 | MenC+ Routine | Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | rMenB Lot1 | Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| BG001 | rMenB Lot2 | Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| BG002 | rMenB Lot3 | Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| BG003 | Routine | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
| BG004 | MenC+ Routine | Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. |
| BG005 | 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 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs). | Analysis was done on Per protocol (PP)population - All subjects 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | one month after the third vaccination |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported. | Analysis was done on PP population - All subjects 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. | Posted | Number | 95% Confidence Interval | Percentages of subjects | one month after the third vaccination |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination. | Analysis was done on Per protocol (PP)population - All subjects 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. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month after the third vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ. | Analysis was done on Per protocol (PP)population - All subjects 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 Month after the third vaccination |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination. | Analysis was done on PP dataset. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 1 month after third vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination. | Analysis was done on Immunogenicity Routine PP (Pertussis Antigens) | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 1 month after third vaccination |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects With Antibody Response Against the Routine Antigens | The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL. HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml | Analysis was done on PP population. | Posted | Number | 95% Confidence Interval | Percentages Of Subjects | 1 Month after third vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid). | Analysis was done on PP dataset. | Posted | Number | 95% Confidence Interval | Percentages of Subjects | 5 months |
|
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| Secondary | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age. | Analysis was done on PP dataset. | Posted | Number | 95% Confidence Interval | Percentages of Subjects | 1 Month after third vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:8 | Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains. | Analysis was done on PP population | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month after third vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events. | The analysis was done on safety subset population - all subjects enrolled who received study vaccination and provided post-baseline safety data. | Posted | Number | Participants | upto 7 days after any vaccination |
|
|
All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
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 | rMenB Lot1 | Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | 70 | 832 | 827 | 832 | ||
| EG001 | rMenB Lot2 | Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | 80 | 828 | 825 | 828 | ||
| EG002 | rMenB Lot3 | Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | 60 | 820 | 817 | 820 | ||
| EG003 | Routine | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. | 51 | 659 | 652 | 659 | ||
| EG004 | MenC+Routine | Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age. | 28 | 490 | 482 | 490 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cerebral Palsy | Congenital, familial and genetic disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Congenital Coronary Artery Malformation | Congenital, familial and genetic disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Faciodigitogenital Dysplasia | Congenital, familial and genetic disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Gnathoschisis | Congenital, familial and genetic disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Microcephaly | Congenital, familial and genetic disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Thalassaemia Beta | Congenital, familial and genetic disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Infantile Colic | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Intusscusception | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Exanthema Subitum | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Febrile Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Gastroenteritis Adenovirus | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Gastroenteritis Salmonella | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pseudocroup | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Respiratory syncytial virus | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| H1N1 Influenza | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Tonsilitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Accidental exposure | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Bone fissure | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Foregin body trauma | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| vaccination complication | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Feeding disorder or infancy or early childhood | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Weight gain poor | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Premature closure of cranial sutures | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Infantile spasms | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Breath Holding | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Decreased activity | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Balanitis | Reproductive system and breast disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Eczema Nummular | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Labial frenectomy | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Tendon operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Kawasaki's disease | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (12.1) | 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 |
| |
| Crying | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vaccination site induration | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | 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 |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
Not provided
Not provided
| Male |
|
| 44/76-SL strain one month after 3rd vaccination |
|
|
| 5/99 strain (Baseline) |
|
|
| 5/99 strain one month after 3rd vaccination |
|
|
| NZ98/254 strain (Baseline) |
|
|
| one month after 3rd vaccination |
|
|
The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.
| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs. | hSBA GMT ratios | 1.02 | 2-Sided | 95 | 0.93 | 1.13 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot. |
| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs. | hSBA GMT ratios | 1.14 | 2-Sided | 95 | 1.03 | 1.27 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot. |
| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs. | hSBA GMT ratios | 0.88 | 2-Sided | 95 | 0.78 | 0.98 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot. |
| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs. | hSBA GMT ratios | 0.99 | 2-Sided | 95 | 0.88 | 1.1 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot. |
| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs | hSBA GMT ratios | 1.12 | 2-Sided | 95 | 1.0 | 1.26 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot. |
| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs. | hSBA GMT ratios | 1.04 | 95 | 0.88 | 1.23 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot. |
| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs. | hSBA GMT ratios | 0.96 | 95 | 0.81 | 1.13 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot. |
| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for NZ98 /254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs. | hSBA GMT ratios | 0.92 | 2-Sided | 95 | 0.78 | 1.08 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for for NZ98 /254 strain with respect to the immune response to the vaccine lot. |
| Participants |
|
|
| OG003 | Routine | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
|
|
|
|
| OG004 | Routine | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot2, or Lot3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
| OG004 | Routine | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
|
|
| OG004 | Routine | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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