A Phase 2 interventional study of rMenB and rMenB+OMV in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 1 site in United Kingdom. Open to participants aged 6 Months to 8 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by Novartis Vaccines · Phase 2, Interventional, and Prevention
To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 60 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6-8 months-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.
Biological: rMenB
6-8 months-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.
Biological: rMenB+OMV
One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
Also known as: Serogroup B meningococcal recombinant vaccine without OMV-NZ
One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
Also known as: Serogroup B meningococcal recombinant vaccine with OMV-NZ
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).
Time frame: Baseline and one month after second and third vaccination
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: Baseline and one month after second and third vaccination
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: One month after second and third vaccination
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: Baseline and one month after second and third vaccination
Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: Baseline and one month after second and third vaccination
Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: One month after second and third vaccination
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).
Time frame: Day 1 through day 7 after each vaccination
Subjects were enrolled at one study center in the United Kingdom (UK).
| Milestone | rMenB | rMenB+OMV |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 27 |
| Not completed | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).
| Percentage of subjects | rMenB | rMenB+OMV |
|---|---|---|
| Strain 44/76-SL - Baseline | 8 (1 to 26) | 29 (13 to 51) |
| Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 100 (86 to 100) | 100 (85 to 100) |
| Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 (86 to 100) | 100 (86 to 100) |
| Strain 5/99 - Baseline | 0 (0 to 14) | 0 (0 to 14) |
| Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 (86 to 100) | 100 (85 to 100) |
| Strain 5/99 - Post-3rd Vaccination (N=24,24) | 100 (86 to 100) | 100 (86 to 100) |
| Strain NZ98/254 - Baseline | 0 (0 to 14) | 0 (0 to 14) |
| Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 4 (0 to 21) | 95 (77 to 100) |
| Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 9 (1 to 29) | 96 (79 to 100) |
| Strain UK P1.7-2,4 - Baseline (N=24,21) | 0 (0 to 14) | 0 (0 to 16) |
| Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 0 (0 to 15) | 100 (82 to 100) |
| Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 5 (0 to 24) | 100 (85 to 100) |
| Strain GB101 - Baseline (N=24,21) | 0 (0 to 14) | 10 (1 to 30) |
| Strain GB101 - Post-2nd Vaccination (N=22,21) | 23 (8 to 45) | 67 (43 to 85) |
| Strain GB101 - Post-3rd Vaccination (N=22,22) | 27 (11 to 50) | 73 (50 to 89) |
| Strain GB355 - Baseline (N=12,11) | 0 (0 to 26) | 0 (0 to 28) |
| Strain GB355 - Post-2nd Vaccination (N=11,14) | 0 (0 to 28) | 7 (0 to 34) |
| Strain GB355 - Post-3rd Vaccination (N=12,11) | 0 (0 to 26) | 18 (2 to 52) |
| Strain GB364 - Baseline (N=22,17) | 9 (1 to 29) | 12 (1 to 36) |
| Strain GB364 - Post-2nd Vaccination (N=19,16) | 95 (74 to 100) | 88 (62 to 98) |
| Strain GB364 - Post-3rd Vaccination (N=17,19) | 88 (64 to 99) | 95 (74 to 100) |
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
| Percentage of subjects | rMenB | rMenB+OMV |
|---|---|---|
| Strain 44/76-SL - Baseline | 0 (0 to 14) | 4 (0 to 21) |
| Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 96 (80 to 100) | 100 (85 to 100) |
| Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 (86 to 100) | 100 (86 to 100) |
| Strain 5/99 - Baseline | 0 (0 to 14) | 0 (0 to 14) |
| Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 (86 to 100) | 100 (85 to 100) |
| Strain 5/99 - Post-3rd Vaccination (N=24,24) | 100 (86 to 100) | 100 (86 to 100) |
| Strain NZ98/254 - Baseline | 0 (0 to 14) | 0 (0 to 14) |
| Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 0 (0 to 14) | 91 (71 to 99) |
| Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 5 (0 to 23) | 96 (79 to 100) |
| Strain UK P1.7-2,4 - Baseline (N=24,21) | 0 (0 to 14) | 0 (0 to 16) |
| Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 0 (0 to 15) | 84 (60 to 97) |
| Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 0 (0 to 16) | 95 (77 to 100) |
| Strain GB101 - Baseline (N=24,21) | 0 (0 to 14) | 10 (1 to 30) |
| Strain GB101 - Post-2nd Vaccination (N=22,21) | 9 (1 to 29) | 33 (15 to 57) |
| Strain GB101 - Post-3rd Vaccination (N=22,22) | 14 (3 to 35) | 45 (24 to 68) |
| Strain GB355 - Baseline (N=12,11) | 0 (0 to 26) | 0 (0 to 28) |
| Strain GB355 - Post-2nd Vaccination (N=11,14) | 0 (0 to 28) | 0 (0 to 23) |
| Strain GB355 - Post-3rd Vaccination (N=12,11) | 0 (0 to 26) | 0 (0 to 28) |
| Strain GB364 - Baseline (N=22,17) | 0 (0 to 15) | 0 (0 to 20) |
| Strain GB364 - Post-2nd Vaccination (N=19,16) | 74 (49 to 91) | 69 (41 to 89) |
| Strain GB364 - Post-3rd Vaccination (N=17,19) | 71 (44 to 90) | 84 (60 to 97) |
Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
| Percentage of subjects | rMenB | rMenB+OMV |
|---|---|---|
| Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 96 (80 to 100) | 100 (85 to 100) |
| Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 (86 to 100) | 100 (86 to 100) |
| Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 (86 to 100) | 100 (85 to 100) |
| Strain 5/99 - Post-3rd Vaccination | 100 (86 to 100) | 100 (86 to 100) |
| Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 0 (0 to 14) | 91 (71 to 99) |
| Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 5 (0 to 23) | 96 (79 to 100) |
| Strain UKP1.7-2,4 - Post-2nd Vaccination (N=22,17) | 0 (0 to 15) | 88 (64 to 99) |
| Strain UKP1.7-2,4 - Post-3rd Vaccination (N=20,20) | 0 (0 to 17) | 95 (75 to 100) |
| Strain GB101 - Post-2nd Vaccination (N=21,18) | 10 (1 to 30) | 22 (6 to 48) |
| Strain GB101 - Post-3rd Vaccination (N=21,19) | 14 (3 to 36) | 32 (13 to 57) |
| Strain GB355 - Post-2nd Vaccination (N=5,7) | 0 (0 to 52) | 0 (0 to 41) |
| Strain GB355 - Post-3rd Vaccination (N=7,6) | 0 (0 to 41) | 0 (0 to 46) |
| Strain GB364 - Post-2nd Vaccination (N=17,14) | 76 (50 to 93) | 64 (35 to 87) |
| Strain GB364 - Post-3rd Vaccination (N=15,15) | 80 (52 to 96) | 80 (52 to 96) |
| 287-953proteinantigen-Post-2ndVaccination(N=25,23) | 100 (86 to 100) | 100 (85 to 100) |
| 287-953proteinantigen-Post-3rdVaccination(N=24,25) | 100 (86 to 100) | 100 (86 to 100) |
The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
| Geometric mean titers | rMenB | rMenB+OMV |
|---|---|---|
| Strain 44/76-SL - Baseline | 1.16 (0.89 to 1.52) | 1.70 (1.29 to 2.24) |
| Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 94 (66 to 134) | 250 (173 to 361) |
| Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 109 (79 to 153) | 189 (136 to 263) |
| Strain 5/99 - Baseline | 1.00 (0.94 to 1.07) | 1.05 (0.98 to 1.12) |
| Strain 5/99 - Post-2nd Vaccination (N=25,23) | 710 (532 to 947) | 534 (395 to 721) |
| Strain 5/99 - Post-3rd Vaccination (N=24,24) | 1202 (929 to 1555) | 906 (700 to 1172) |
| Strain NZ98/254 - Baseline | 1.00 (1.00 to 1.00) | 1.00 (1.00 to 1.00) |
| Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 1.06 (0.82 to 1.38) | 27 (21 to 36) |
| Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 1.21 (0.86 to 1.72) | 44 (32 to 62) |
| Strain UK P1.7-2,4 - Baseline (N=24,21) | 1.00 (1.00 to 1.00) | 1.00 (1.00 to 1.00) |
| Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 1.00 (0.75 to 1.34) | 17 (12 to 24) |
| Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 1.07 (0.72 to 1.58) | 34 (23 to 50) |
| Strain GB101 - Baseline (N=24,21) | 1.12 (0.81 to 1.56) | 1.49 (1.05 to 2.11) |
| Strain GB101 - Post-2nd Vaccination (N=22,21) | 1.82 (1.14 to 2.90) | 4.56 (2.83 to 7.35) |
| Strain GB101 - Post-3rd Vaccination (N=22,22) | 2.20 (1.14 to 4.23) | 9.36 (4.87 to 18) |
| Strain GB355 - Baseline (N=12,11) | 1.00 (1.00 to 1.00) | 1.00 (1.00 to 1.00) |
| Strain GB355 - Post-2nd Vaccination (N=11,14) | 1.00 (0.83 to 1.21) | 1.16 (0.98 to 1.37) |
| Strain GB355 - Post-3rd Vaccination (N=12,11) | 1.06 (0.82 to 1.36) | 1.46 (1.12 to 1.90) |
| Strain GB364 - Baseline (N=22,17) | 1.46 (1.19 to 1.79) | 1.50 (1.19 to 1.90) |
| Strain GB364 - Post-2nd Vaccination (N=19,16) | 11 (6.39 to 19) | 12 (6.75 to 23) |
| Strain GB364 - Post-3rd Vaccination (N=17,19) | 12 (6.17 to 22) | 21 (11 to 37) |
The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
| µg/mL | rMenB | rMenB+OMV |
|---|---|---|
| Antigen 287-953 - Baseline | 24 (21 to 28) | 21 (18 to 24) |
| Antigen 287-953 - Post-2nd Vaccination (N=25,23) | 1759 (1331 to 2324) | 2912 (2178 to 3894) |
| Antigen 287-953 - Post-3rd Vaccination (N=24,25) | 2298 (1778 to 2970) | 3521 (2739 to 4527) |
Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
| Percentage of subjects | rMenB | rMenB+OMV |
|---|---|---|
| Antigen 287-953 - Post-2nd Vaccination (N=25,23) | 100 (86 to 100) | 100 (85 to 100) |
| Antigen 287-953 - Post-3rd Vaccination (N=24,25) | 100 (86 to 100) | 100 (86 to 100) |
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).
| Number of subjects | rMenB | rMenB+OMV |
|---|---|---|
| Local reactions | 29 | 29 |
| Tenderness - Vaccination 1 | 4 | 9 |
| Tenderness - Vaccination 2 (N=30,28) | 5 | 11 |
| Tenderness - Vaccination 3 (N=30,27) | 12 | 10 |
| Erythema - Vaccination 1 | 26 | 26 |
| Erythema - Vaccination 2 (N=30,28) | 22 | 25 |
| Erythema - Vaccination 3 (N=30,27) | 24 | 26 |
| Induration - Vaccination 1 | 15 | 18 |
| Induration - Vaccination 2 (N=30,28) | 12 | 16 |
| Induration - Vaccination 3 (N=30,27) | 15 | 18 |
| Swelling - Vaccination 1 | 4 | 11 |
| Swelling - Vaccination 2 (N=30,28) | 9 | 10 |
| Swelling - Vaccination 3 (N=30,27) | 11 | 9 |
| Systemic reactions | 22 | 28 |
| Change in eating habits - Vaccination 1 (N=30,29) | 6 | 8 |
| Change in eating habits - Vaccination 2 (N=30,27) | 1 | 7 |
| Change in eating habits - Vaccination 3 (N=30,27) | 8 | 5 |
| Sleepiness - Vaccination 1 | 7 | 11 |
| Sleepiness - Vaccination 2 (N=30,28) | 7 | 8 |
| Sleepiness - Vaccination 3 (N=30,27) | 7 | 4 |
| Vomiting - Vaccination 1 | 6 | 4 |
| Vomiting - Vaccination 2 (N=30,28) | 1 | 3 |
| Vomiting - Vaccination 3 (N=30,27) | 6 | 2 |
| Diarrhea - Vaccination 1 | 2 | 5 |
| Diarrhea - Vaccination 2 (N=30,28) | 4 | 1 |
| Diarrhea - Vaccination 3 (N=30,27) | 5 | 5 |
| Unusual crying - Vaccination 1 | 2 | 3 |
| Unusual crying - Vaccination 2 (N=30,28) | 2 | 2 |
| Unusual crying - Vaccination 3 (N=30,27) | 4 | 7 |
| Irritability - Vaccination 1 | 14 | 14 |
| Irritability - Vaccination 2 (N=30,28) | 10 | 17 |
| Irritability - Vaccination 3 (N=30,28) | 13 | 18 |
| Rash - Vaccination 1 | 3 | 3 |
| Rash - Vaccination 2 (N=30,28) | 5 | 4 |
| Rash - Vaccination 3 (N=30,27) | 5 | 4 |
| Fever (≥38 °C) - Vaccination 1 | 1 | 3 |
| Fever (≥38 °C) - Vaccination 2 (N=30,28) | 2 | 3 |
| Fever (≥38 °C) - Vaccination 3 (N=30,27) | 4 | 1 |
| Analg/Antipyr medications used - Vaccination 1 | 10 | 18 |
| Analg/Antipyr medications used - Vaccination 2 | 12 | 17 |
| Analg/Antipyr medications used - Vaccination 3 | 15 | 16 |
Collected over Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rMenB | — | 5/30 (16.7%) | 30/30 (100%) |
| rMenB+OMV | — | 1/30 (3.3%) | 30/30 (100%) |
| Event | rMenB | rMenB+OMV |
|---|---|---|
| CellulitisInfections and infestations | 1/30 | 0/30 |
| Croup infectiousInfections and infestations | 1/30 | 0/30 |
| GastroenteritisInfections and infestations | 1/30 | 0/30 |
| Localised infectionInfections and infestations | 1/30 | 0/30 |
| Febrile convulsionNervous system disorders | 0/30 | 1/30 |
| WheezingRespiratory, thoracic and mediastinal disorders | 1/30 | 0/30 |
| Event | rMenB | rMenB+OMV |
|---|---|---|
| Injection site erythemaGeneral disorders | 28/30 | 28/30 |
| Injection site indurationGeneral disorders | 20/30 | 26/30 |
| IrritabilityPsychiatric disorders | 18/30 | 25/30 |
| Injection site painGeneral disorders | 13/30 | 18/30 |
| Injection site swellingGeneral disorders | 14/30 | 17/30 |
| SomnolenceNervous system disorders | 14/30 | 16/30 |
| DiarrhoeaGastrointestinal disorders | 16/30 | 13/30 |
| VomitingGastrointestinal disorders | 16/30 | 10/30 |
| Eating disorderPsychiatric disorders | 13/30 | 14/30 |
| TeethingGastrointestinal disorders | 11/30 | 13/30 |
Analysis was performed on all enrolled subjects.
| Age, Continuous(Months) | rMenB | rMenB+OMV | Total |
|---|---|---|---|
| Mean | 7.0 ± 0.8 | 7.1 ± 0.7 | 7.1 ± 0.7 |
| Sex: Female, Male(Participants) | rMenB | rMenB+OMV | Total |
|---|---|---|---|
| Female | 14 | 18 | 32 |
| Male | 16 | 12 | 28 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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