A Phase 3 interventional study of rMenB+OMV and rMenB+OMV in Meningococcal Disease, sponsored by Novartis. Completed at 20 sites in 5 countries. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-15.
Sponsored by Novartis · Phase 3, Interventional, and Prevention
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 239 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criterion applicable to All Groups
Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies
Inclusion criterion applicable to Group B
Inclusion criterion applicable to Group C - healthy subjects
Exclusion Criteria:
Exclusion criteria applicable to All Groups (A, B and C)
Exclusion criterion applicable to Groups A and B
Exclusion criteria applicable to Group C
Complement deficiency
Biological: rMenB+OMV
asplenia/splenic dysfunction
Biological: rMenB+OMV
age-matched healthy controls
Biological: rMenB+OMV
2 doses of vaccine 2 months apart
2 doses of vaccine 2 months apart
2 doses of vaccine 2 months apart
Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine)
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time frame: Day 91 (one month after the second dose of the study vaccine).
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time frame: Day 91 (one month after the second dose of the study vaccine).
Number Of Subjects With Unsolicited Adverse Events (AEs).
Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).
Time frame: At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)
Number of Subjects Reporting Solicited Local and Systemic AEs.
Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.
Time frame: From Day 1 until Day 7 after any vaccination.
Subjects were enrolled at 4 centers in Italy, 3 centers in Poland, 3 centers in the Russian Federation, 4 centers in Spain and 4 centers in the United Kingdom.
| Milestone | CompDef | Asplenia | Healthy |
|---|---|---|---|
| Started | 40 | 112 | 87 |
| Completed | 40 | 107 | 87 |
| Not completed | 0 | 5 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Other | 0 | 3 | 0 |
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
| Percentage of Subjects | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| 5/99 - Day 1 (N=37,103,140,82) | 0 (0 to 9.5) | 12 (6.2 to 19.5) | 9 (4.5 to 14.5) | 6 (2 to 13.7) |
| 5/99 - Day 91 (N=38,106,144,83) | 95 (82.3 to 99.4) | 100 (96.6 to 100) | 99 (95.1 to 99.83) | 99 (93.5 to 99.97) |
| H44/76 - Day 1 (N=39,104,143,84) | 0 (0 to 9) | 7 (2.7 to 13.4) | 5 (2 to 9.8) | 6 (2 to 13.3) |
| H44/76 - Day 91 (N=39,104,143,85) | 87 (72.6 to 95.7) | 97 (91.8 to 99.4) | 94 (89.3 to 97.6) | 98 (91.8 to 99.71) |
| M10713 - Day 1 (N=36,102,138,82) | 56 (38.1 to 72.1) | 79 (70.3 to 86.8) | 73 (65 to 80.4) | 78 (67.5 to 86.4) |
| M10713 - Day 91 (N=37,103,140,83) | 73 (55.9 to 86.2) | 94 (87.8 to 97.8) | 89 (82.1 to 93.3) | 99 (93.5 to 99.97) |
| NZ98/254 - Day 1 (N=36,105,141,83) | 0 (0 to 9.7) | 4 (1 to 9.5) | 3 (0.8 to 7.1) | 2 (0.29 to 8.4) |
| NZ98/254 - Day 91 (N=38,106,144,84) | 68 (51.3 to 82.5) | 86 (77.7 to 91.9) | 81 (73.9 to 87.3) | 83 (73.6 to 90.6) |
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
| Percentage of Subjects | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| 5/99 - Day 1 (N=37,103,140,82) | 0 (0 to 9.5) | 11 (5.5 to 18.3) | 8 (4 to 13.6) | 5 (1.3 to 12) |
| 5/99 - Day 91 (N=38,106,144,83) | 92 (78.6 to 98.3) | 100 (96.6 to 100) | 98 (94 to 99.57) | 99 (93.5 to 99.97) |
| H44/76 - Day 1 (N=39,104,143,84) | 0 (0 to 9) | 2 (0.23 to 6.8) | 1 (0.17 to 5) | 2 (0.29 to 8.3) |
| H44/76 - Day 91 (N=39,104,143,85) | 87 (72.6 to 95.7) | 95 (89.1 to 98.4) | 93 (87.5 to 96.6) | 98 (91.8 to 99.71) |
| M10713 - Day 1 (N=36,102,138,82) | 47 (30.4 to 64.5) | 68 (57.7 to 76.6) | 62 (53.7 to 70.4) | 68 (57.1 to 78.1) |
| M10713 - Day 91 (N=37,103,140,83) | 70 (53 to 84.1) | 94 (87.8 to 97.8) | 88 (81.3 to 92.8) | 98 (91.6 to 99.71) |
| NZ98/254 - Day 1 (N=36,105,141,83) | 0 (0 to 9.7) | 4 (1 to 9.5) | 3 (0.8 to 7.1) | 0 (0 to 4.3) |
| NZ98/254 - Day 91 (N=38,106,144,84) | 63 (46 to 78.2) | 79 (70.3 to 86.5) | 75 (67.1 to 81.8) | 73 (61.8 to 81.8) |
Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
| Ratios | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| 5/99 - Day 91/Day 1 (N=37,103,140,82) | 299 (170 to 525) | 207 (149 to 288) | 228 (173 to 302) | 245 (187 to 321) |
| H44/76 - Day 91/Day 1 (N=39,104,143,84) | 44 (27 to 73) | 56 (41 to 75) | 52 (41 to 67) | 66 (52 to 83) |
| M10713 - Day 91/Day 1 (N=36,102,138,82) | 2.25 (1.37 to 3.71) | 2.95 (2.21 to 3.95) | 2.75 (2.15 to 3.51) | 2.71 (2.02 to 3.65) |
| NZ98/254 - Day 91/Day 1 (N=36,105,141,83) | 8.58 (4.9 to 15) | 16 (12 to 22) | 14 (10 to 18) | 13 (10 to 17) |
Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
| Titers | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| 5/99 - Day 1 (N=37,103,140,82) | 0.87 (0.61 to 1.26) | 1.43 (1.16 to 1.78) | 1.26 (1.05 to 1.51) | 1.24 (1.02 to 1.52) |
| 5/99 - Day 91 (N=38,106,144,83) | 263 (166 to 415) | 300 (230 to 392) | 290 (231 to 362) | 307 (250 to 376) |
| H44/76 - Day 1 (N=39,104,143,84) | 1.08 (0.87 to 1.33) | 1.17 (1.03 to 1.32) | 1.14 (1.03 to 1.26) | 1.15 (1.03 to 1.28) |
| H44/76 - Day 91 (N=39,104,143,85) | 48 (29 to 79) | 65 (48 to 88) | 60 (46 to 77) | 76 (61 to 94) |
| M10713 - Day 1 (N=36,102,138,82) | 8.57 (4.43 to 17) | 15 (10 to 22) | 13 (9.44 to 18) | 16 (11 to 22) |
| M10713 - Day 91 (N=37,103,140,83) | 20 (11 to 34) | 45 (33 to 62) | 36 (28 to 47) | 42 (34 to 52) |
| NZ98/254 - Day 1 (N=36,105,141,83) | 0.95 (0.78 to 1.16) | 1.1 (0.98 to 1.24) | 1.06 (0.96 to 1.17) | 1.05 (0.98 to 1.12) |
| NZ98/254 - Day 91 (N=38,106,144,84) | 8.46 (4.85 to 15) | 18 (13 to 24) | 14 (11 to 19) | 14 (10 to 18) |
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
| Percentage of Subjects | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| 5/99 - Day 91 (N=37,103,140,82) | 92 (78.1 to 98.3) | 100 (96.5 to 100) | 98 (93.9 to 99.56) | 98 (91.5 to 99.70) |
| H44/76 - Day 91 (N=39,104,143,84) | 87 (72.6 to 95.7) | 94 (87.9 to 97.9) | 92 (86.7 to 96.1) | 98 (91.7 to 99.71) |
| M10713 - Day 91 (N=36,102,138,82) | 25 (12.1 to 42.2) | 33 (24.3 to 43.4) | 31 (23.6 to 39.6) | 33 (22.9 to 44.2) |
| NZ98/254 - Day 91 (N=36,105,141,83) | 61 (43.5 to 76.9) | 80 (71.1 to 87.2) | 75 (67.2 to 82.1) | 73 (62.7 to 82.6) |
Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
| IU/mL | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| 287-953 - Day 1 (N=39,106,145,84) | 33 (25 to 43) | 25 (21 to 29) | 27 (23 to 31) | 27 (23 to 31) |
| 287-953 - Day 91 (N=40,106,146,84) | 2039 (1436 to 2894) | 3418 (2780 to 4202) | 2973 (2492 to 3546) | 2957 (2450 to 3570) |
Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
| Ratios | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule. | 62 (40 to 97) | 138 (107 to 178) | 112 (90 to 193) | 111 (88 to 140) |
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
| Percentage of Subjects | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953. | 97 (86.5 to 99.4) | 98 (93.4 to 99.77) | 98 (94.1 to 99.57) | 98 (91.7 to 99.71) |
Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.
| participants | CompDef | Asplenia | CompDef + Asplenia | Healthy | Total |
|---|---|---|---|---|---|
| Any (< 6 years; N=12,9,21,13,34) | 12 | 8 | 20 | 13 | 33 |
| Any Local (< 6 years; N=12,9,21,13,34) | 12 | 6 | 18 | 12 | 30 |
| Any Systemic (< 6 years; N=12,9,21,13,34) | 11 | 6 | 17 | 12 | 29 |
| Any (≥ 6 years) | 27 | 98 | 125 | 74 | 199 |
| Any Local (≥ 6 years) | 26 | 98 | 124 | 74 | 198 |
| Any Systemic (≥ 6 years) | 21 | 75 | 96 | 60 | 156 |
| Erythema (< 6 years; N=12,9,21,13,34) | 7 | 4 | 11 | 6 | 17 |
| Induration (< 6 years; N=12,9,21,13,34) | 5 | 4 | 9 | 5 | 14 |
| Swelling (< 6 years; N=12,9,21,13,34) | 6 | 4 | 10 | 6 | 16 |
| Tenderness (<6 years; N=12,9,21,13,34) | 12 | 6 | 18 | 12 | 30 |
| Change in Eating Habits (<6 years;N=12,9,21,13,34) | 5 | 1 | 6 | 8 | 14 |
| Diarrhea (< 6 years; N=12,9,21,13,34) | 5 | 3 | 8 | 3 | 11 |
| Irritability (< 6 years; N=12,9,21,13,34) | 6 | 2 | 8 | 9 | 17 |
| Persistent Crying (< 6 years; N=12,9,21,13,34) | 2 | 2 | 4 | 6 | 10 |
| Rash (< 6 years; N=12,9,21,13,34) | 3 | 0 | 3 | 0 | 3 |
| Sleepiness (< 6 years; N=12,9,21,13,34) | 7 | 3 | 10 | 5 | 15 |
| Vomiting (< 6 years; N=12,9,21,13,34) | 2 | 0 | 2 | 0 | 2 |
| Fever (≥38°C) (< 6 years; N=12,9,21,13,34) | 3 | 1 | 4 | 4 | 8 |
| Prevention Pain/Fever (<6 years; N=12,9,21,13,34) | 5 | 1 | 6 | 4 | 10 |
| Treat. P/F (< 6 years; N=12,9,21,13,34) | 5 | 3 | 8 | 11 | 19 |
| Erythema (≥ 6 years) | 7 | 19 | 26 | 27 | 53 |
| Induration (≥ 6 years) | 11 | 27 | 38 | 19 | 57 |
| Swelling (≥ 6 years) | 8 | 24 | 32 | 24 | 56 |
| Pain (≥ 6 years) | 25 | 97 | 122 | 71 | 193 |
| Arthralgia (≥ 6 years) | 7 | 25 | 32 | 18 | 50 |
| Fatigue (≥ 6 years) | 11 | 55 | 66 | 46 | 112 |
| Headache (≥ 6 years) | 11 | 47 | 58 | 35 | 93 |
| Myalgia (≥ 6 years; N=28,100,128,73,201) | 8 | 31 | 39 | 27 | 66 |
| Nausea (≥ 6 years) | 7 | 28 | 35 | 15 | 50 |
| Rash (≥ 6 years) | 7 | 9 | 16 | 6 | 22 |
| Fever (≥ 38°C) (≥ 6 years) | 6 | 6 | 12 | 5 | 17 |
| Prev. Pain/Fever (≥ 6 years) | 5 | 9 | 14 | 15 | 29 |
| Treat. Pain/Fever (≥ 6 years) | 14 | 39 | 53 | 38 | 91 |
Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).
| participants | CompDef | Asplenia | CompDef + Asplenia | Healthy |
|---|---|---|---|---|
| Any AE | 17 | 38 | 55 | 34 |
| At least possibly related AEs | 9 | 19 | 28 | 18 |
| Any SAEs | 1 | 5 | 6 | 0 |
| At least Possibly Related SAEs | 0 | 0 | 0 | 0 |
| AEs Leading to Death | 0 | 0 | 0 | 0 |
| AEs Leading to Withdrawal | 0 | 1 | 1 | 0 |
| Medically Attended AEs | 13 | 26 | 39 | 18 |
Collected over Throughout the entire study period (Day 1 to Day 91). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CompDef | — | 1/40 (2.5%) | 39/40 (97.5%) |
| Asplenia | — | 5/110 (4.5%) | 106/110 (96.4%) |
| CompDef + Asplenia | — | 6/150 (4%) | 145/150 (96.7%) |
| Healthy | — | 0/87 (0%) | 87/87 (100%) |
| Total | — | 6/237 (2.5%) | 232/237 (97.9%) |
| Event | CompDef | Asplenia | CompDef + Asplenia | Healthy | Total |
|---|---|---|---|---|---|
| RESPIRATORY TRACT INFECTION VIRALInfections and infestations | 1/40 | 0/110 | 1/150 | 0/87 | 1/237 |
| INTRACARDIAC THROMBUSCardiac disorders | 0/40 | 1/110 | 1/150 | 0/87 | 1/237 |
| APPENDICITISInfections and infestations | 0/40 | 1/110 | 1/150 | 0/87 | 1/237 |
| GASTROENTERITIS SALMONELLAInfections and infestations | 0/40 | 1/110 | 1/150 | 0/87 | 1/237 |
| TONSILLITISInfections and infestations | 0/40 | 1/110 | 1/150 | 0/87 | 1/237 |
| CONCUSSIONInjury, poisoning and procedural complications | 0/40 | 1/110 | 1/150 | 0/87 | 1/237 |
| RESPIRATORY DISORDERRespiratory, thoracic and mediastinal disorders | 0/40 | 1/110 | 1/150 | 0/87 | 1/237 |
| Event | CompDef | Asplenia | CompDef + Asplenia | Healthy | Total |
|---|---|---|---|---|---|
| INJECTION SITE PAINGeneral disorders | 37/40 | 103/110 | 140/150 | 83/87 | 223/237 |
| FATIGUEGeneral disorders | 11/40 | 55/110 | 66/150 | 46/87 | 112/237 |
| HEADACHENervous system disorders | 11/40 | 48/110 | 59/150 | 35/87 | 94/237 |
| INJECTION SITE INDURATIONGeneral disorders | 17/40 | 32/110 | 49/150 | 26/87 | 75/237 |
| INJECTION SITE ERYTHEMAGeneral disorders | 15/40 | 23/110 | 38/150 | 34/87 | 72/237 |
| INJECTION SITE SWELLINGGeneral disorders | 14/40 | 28/110 | 42/150 | 32/87 | 74/237 |
| MYALGIAMusculoskeletal and connective tissue disorders | 8/40 | 31/110 | 39/150 | 27/87 | 66/237 |
| NAUSEAGastrointestinal disorders | 7/40 | 28/110 | 35/150 | 15/87 | 50/237 |
| PYREXIAGeneral disorders | 10/40 | 7/110 | 17/150 | 10/87 | 27/237 |
| RASHSkin and subcutaneous tissue disorders | 10/40 | 9/110 | 19/150 | 6/87 | 25/237 |
| Age, Continuous(Years) | CompDef | Asplenia | Healthy | Total |
|---|---|---|---|---|
| Mean | 8.5 ± 4.35 | 11.1 ± 3.7 | 10.2 ± 4.14 | 10.3 ± 4.07 |
| Sex/Gender, Customized(participants) | CompDef | Asplenia | Healthy | Total |
|---|---|---|---|---|
| Female | 17 | 46 | 44 | 107 |
| Male | 23 | 66 | 43 | 132 |
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