Trial Outcomes & Findings for Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects. (NCT NCT02141516)

Last Updated: 2017-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

239 participants

Primary outcome timeframe

Day 1 and Day 91 (one month after the second dose of the study vaccine)

Results posted on

2017-02-15

Participant Flow

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.

All the enrolled subjects were included in the trial. One subject did not complete the study because he/she did not meet criteria for re-vaccination; two subjects met enrollment delay criteria since they required regular blood transfusions and they were unable to commit to visit windows (screen failure).

Participant milestones

Participant milestones
Measure	CompDef Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
Overall Study STARTED	40	112	87
Overall Study COMPLETED	40	107	87
Overall Study NOT COMPLETED	0	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CompDef Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
Overall Study Adverse Event	0	1	0
Overall Study Lost to Follow-up	0	1	0
Overall Study Other	0	3	0

Baseline Characteristics

Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CompDef n=40 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=112 Participants Subjects aged ≥ 2 to ≤17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=87 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total n=239 Participants Total of all reporting groups
Age, Continuous	8.5 Years STANDARD_DEVIATION 4.35 • n=5 Participants	11.1 Years STANDARD_DEVIATION 3.7 • n=7 Participants	10.2 Years STANDARD_DEVIATION 4.14 • n=5 Participants	10.3 Years STANDARD_DEVIATION 4.07 • n=4 Participants
Sex/Gender, Customized Female	17 participants n=5 Participants	46 participants n=7 Participants	44 participants n=5 Participants	107 participants n=4 Participants
Sex/Gender, Customized Male	23 participants n=5 Participants	66 participants n=7 Participants	43 participants n=5 Participants	132 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine)

Population: Analysis was done on Full Analysis Set (all subjects in the enrolled set who: received a study vaccination and provided an evaluable serum sample at 1 month after the second dose of rMenB+OMV NZ, with assay result available for at least one of the serogroup B indicator strains or M10713 strain or ELISA).

Outcome measures

Outcome measures
Measure	CompDef n=39 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=106 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=145 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=85 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
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. 5/99 - Day 1 (N=37,103,140,82)	0 Percentage of Subjects Interval 0.0 to 9.5	12 Percentage of Subjects Interval 6.2 to 19.5	9 Percentage of Subjects Interval 4.5 to 14.5	6 Percentage of Subjects Interval 2.0 to 13.7	—
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. 5/99 - Day 91 (N=38,106,144,83)	95 Percentage of Subjects Interval 82.3 to 99.4	100 Percentage of Subjects Interval 96.6 to 100.0	99 Percentage of Subjects Interval 95.1 to 99.83	99 Percentage of Subjects Interval 93.5 to 99.97	—
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. H44/76 - Day 1 (N=39,104,143,84)	0 Percentage of Subjects Interval 0.0 to 9.0	7 Percentage of Subjects Interval 2.7 to 13.4	5 Percentage of Subjects Interval 2.0 to 9.8	6 Percentage of Subjects Interval 2.0 to 13.3	—
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. H44/76 - Day 91 (N=39,104,143,85)	87 Percentage of Subjects Interval 72.6 to 95.7	97 Percentage of Subjects Interval 91.8 to 99.4	94 Percentage of Subjects Interval 89.3 to 97.6	98 Percentage of Subjects Interval 91.8 to 99.71	—
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. M10713 - Day 1 (N=36,102,138,82)	56 Percentage of Subjects Interval 38.1 to 72.1	79 Percentage of Subjects Interval 70.3 to 86.8	73 Percentage of Subjects Interval 65.0 to 80.4	78 Percentage of Subjects Interval 67.5 to 86.4	—
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. M10713 - Day 91 (N=37,103,140,83)	73 Percentage of Subjects Interval 55.9 to 86.2	94 Percentage of Subjects Interval 87.8 to 97.8	89 Percentage of Subjects Interval 82.1 to 93.3	99 Percentage of Subjects Interval 93.5 to 99.97	—
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. NZ98/254 - Day 1 (N=36,105,141,83)	0 Percentage of Subjects Interval 0.0 to 9.7	4 Percentage of Subjects Interval 1.0 to 9.5	3 Percentage of Subjects Interval 0.8 to 7.1	2 Percentage of Subjects Interval 0.29 to 8.4	—
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. NZ98/254 - Day 91 (N=38,106,144,84)	68 Percentage of Subjects Interval 51.3 to 82.5	86 Percentage of Subjects Interval 77.7 to 91.9	81 Percentage of Subjects Interval 73.9 to 87.3	83 Percentage of Subjects Interval 73.6 to 90.6	—

PRIMARY outcome

Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	CompDef n=40 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=107 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=147 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=87 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. 5/99 - Day 1 (N=37,103,140,82)	0 Percentage of Subjects Interval 0.0 to 9.5	11 Percentage of Subjects Interval 5.5 to 18.3	8 Percentage of Subjects Interval 4.0 to 13.6	5 Percentage of Subjects Interval 1.3 to 12.0	—
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. 5/99 - Day 91 (N=38,106,144,83)	92 Percentage of Subjects Interval 78.6 to 98.3	100 Percentage of Subjects Interval 96.6 to 100.0	98 Percentage of Subjects Interval 94.0 to 99.57	99 Percentage of Subjects Interval 93.5 to 99.97	—
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. H44/76 - Day 1 (N=39,104,143,84)	0 Percentage of Subjects Interval 0.0 to 9.0	2 Percentage of Subjects Interval 0.23 to 6.8	1 Percentage of Subjects Interval 0.17 to 5.0	2 Percentage of Subjects Interval 0.29 to 8.3	—
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. H44/76 - Day 91 (N=39,104,143,85)	87 Percentage of Subjects Interval 72.6 to 95.7	95 Percentage of Subjects Interval 89.1 to 98.4	93 Percentage of Subjects Interval 87.5 to 96.6	98 Percentage of Subjects Interval 91.8 to 99.71	—
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. M10713 - Day 1 (N=36,102,138,82)	47 Percentage of Subjects Interval 30.4 to 64.5	68 Percentage of Subjects Interval 57.7 to 76.6	62 Percentage of Subjects Interval 53.7 to 70.4	68 Percentage of Subjects Interval 57.1 to 78.1	—
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. M10713 - Day 91 (N=37,103,140,83)	70 Percentage of Subjects Interval 53.0 to 84.1	94 Percentage of Subjects Interval 87.8 to 97.8	88 Percentage of Subjects Interval 81.3 to 92.8	98 Percentage of Subjects Interval 91.6 to 99.71	—
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. NZ98/254 - Day 1 (N=36,105,141,83)	0 Percentage of Subjects Interval 0.0 to 9.7	4 Percentage of Subjects Interval 1.0 to 9.5	3 Percentage of Subjects Interval 0.8 to 7.1	0 Percentage of Subjects Interval 0.0 to 4.3	—
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. NZ98/254 - Day 91 (N=38,106,144,84)	63 Percentage of Subjects Interval 46.0 to 78.2	79 Percentage of Subjects Interval 70.3 to 86.5	75 Percentage of Subjects Interval 67.1 to 81.8	73 Percentage of Subjects Interval 61.8 to 81.8	—

PRIMARY outcome

Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	CompDef n=40 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=107 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=147 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=85 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. H44/76 - Day 91/Day 1 (N=39,104,143,84)	44 Ratios Interval 27.0 to 73.0	56 Ratios Interval 41.0 to 75.0	52 Ratios Interval 41.0 to 67.0	66 Ratios Interval 52.0 to 83.0	—
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. 5/99 - Day 91/Day 1 (N=37,103,140,82)	299 Ratios Interval 170.0 to 525.0	207 Ratios Interval 149.0 to 288.0	228 Ratios Interval 173.0 to 302.0	245 Ratios Interval 187.0 to 321.0	—
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. M10713 - Day 91/Day 1 (N=36,102,138,82)	2.25 Ratios Interval 1.37 to 3.71	2.95 Ratios Interval 2.21 to 3.95	2.75 Ratios Interval 2.15 to 3.51	2.71 Ratios Interval 2.02 to 3.65	—
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. NZ98/254 - Day 91/Day 1 (N=36,105,141,83)	8.58 Ratios Interval 4.9 to 15.0	16 Ratios Interval 12.0 to 22.0	14 Ratios Interval 10.0 to 18.0	13 Ratios Interval 10.0 to 17.0	—

PRIMARY outcome

Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	CompDef n=40 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=107 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=147 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=85 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. 5/99 - Day 1 (N=37,103,140,82)	0.87 Titers Interval 0.61 to 1.26	1.43 Titers Interval 1.16 to 1.78	1.26 Titers Interval 1.05 to 1.51	1.24 Titers Interval 1.02 to 1.52	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. 5/99 - Day 91 (N=38,106,144,83)	263 Titers Interval 166.0 to 415.0	300 Titers Interval 230.0 to 392.0	290 Titers Interval 231.0 to 362.0	307 Titers Interval 250.0 to 376.0	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. H44/76 - Day 1 (N=39,104,143,84)	1.08 Titers Interval 0.87 to 1.33	1.17 Titers Interval 1.03 to 1.32	1.14 Titers Interval 1.03 to 1.26	1.15 Titers Interval 1.03 to 1.28	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. H44/76 - Day 91 (N=39,104,143,85)	48 Titers Interval 29.0 to 79.0	65 Titers Interval 48.0 to 88.0	60 Titers Interval 46.0 to 77.0	76 Titers Interval 61.0 to 94.0	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. M10713 - Day 1 (N=36,102,138,82)	8.57 Titers Interval 4.43 to 17.0	15 Titers Interval 10.0 to 22.0	13 Titers Interval 9.44 to 18.0	16 Titers Interval 11.0 to 22.0	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. M10713 - Day 91 (N=37,103,140,83)	20 Titers Interval 11.0 to 34.0	45 Titers Interval 33.0 to 62.0	36 Titers Interval 28.0 to 47.0	42 Titers Interval 34.0 to 52.0	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. NZ98/254 - Day 1 (N=36,105,141,83)	0.95 Titers Interval 0.78 to 1.16	1.1 Titers Interval 0.98 to 1.24	1.06 Titers Interval 0.96 to 1.17	1.05 Titers Interval 0.98 to 1.12	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. NZ98/254 - Day 91 (N=38,106,144,84)	8.46 Titers Interval 4.85 to 15.0	18 Titers Interval 13.0 to 24.0	14 Titers Interval 11.0 to 19.0	14 Titers Interval 10.0 to 18.0	—

PRIMARY outcome

Timeframe: Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	CompDef n=39 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=105 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=144 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=85 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
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. 5/99 - Day 91 (N=37,103,140,82)	92 Percentage of Subjects Interval 78.1 to 98.3	100 Percentage of Subjects Interval 96.5 to 100.0	98 Percentage of Subjects Interval 93.9 to 99.56	98 Percentage of Subjects Interval 91.5 to 99.7	—
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. H44/76 - Day 91 (N=39,104,143,84)	87 Percentage of Subjects Interval 72.6 to 95.7	94 Percentage of Subjects Interval 87.9 to 97.9	92 Percentage of Subjects Interval 86.7 to 96.1	98 Percentage of Subjects Interval 91.7 to 99.71	—
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. M10713 - Day 91 (N=36,102,138,82)	25 Percentage of Subjects Interval 12.1 to 42.2	33 Percentage of Subjects Interval 24.3 to 43.4	31 Percentage of Subjects Interval 23.6 to 39.6	33 Percentage of Subjects Interval 22.9 to 44.2	—
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. NZ98/254 - Day 91 (N=36,105,141,83)	61 Percentage of Subjects Interval 43.5 to 76.9	80 Percentage of Subjects Interval 71.1 to 87.2	75 Percentage of Subjects Interval 67.2 to 82.1	73 Percentage of Subjects Interval 62.7 to 82.6	—

PRIMARY outcome

Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	CompDef n=40 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=106 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=146 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=84 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule. 287-953 - Day 1 (N=39,106,145,84)	33 IU/mL Interval 25.0 to 43.0	25 IU/mL Interval 21.0 to 29.0	27 IU/mL Interval 23.0 to 31.0	27 IU/mL Interval 23.0 to 31.0	—
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule. 287-953 - Day 91 (N=40,106,146,84)	2039 IU/mL Interval 1436.0 to 2894.0	3418 IU/mL Interval 2780.0 to 4202.0	2973 IU/mL Interval 2492.0 to 3546.0	2957 IU/mL Interval 2450.0 to 3570.0	—

PRIMARY outcome

Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	CompDef n=39 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=106 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=145 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=84 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	62 Ratios Interval 40.0 to 97.0	138 Ratios Interval 107.0 to 178.0	112 Ratios Interval 90.0 to 193.0	111 Ratios Interval 88.0 to 140.0	—

PRIMARY outcome

Timeframe: Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

Outcome measures

Outcome measures
Measure	CompDef n=39 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=106 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=145 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=84 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.	97 Percentage of Subjects Interval 86.5 to 99.4	98 Percentage of Subjects Interval 93.4 to 99.77	98 Percentage of Subjects Interval 94.1 to 99.57	98 Percentage of Subjects Interval 91.7 to 99.71	—

PRIMARY outcome

Timeframe: At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)

Population: Analysis was done on the Unsolicited Safety Set (all subjects in the exposed set with postvaccination unsolicited AE records).

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).

Outcome measures

Outcome measures
Measure	CompDef n=40 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=110 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=150 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=87 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total Total of subjects
Number Of Subjects With Unsolicited Adverse Events (AEs). Any AE	17 participants	38 participants	55 participants	34 participants	—
Number Of Subjects With Unsolicited Adverse Events (AEs). At least possibly related AEs	9 participants	19 participants	28 participants	18 participants	—
Number Of Subjects With Unsolicited Adverse Events (AEs). Any SAEs	1 participants	5 participants	6 participants	0 participants	—
Number Of Subjects With Unsolicited Adverse Events (AEs). At least Possibly Related SAEs	0 participants	0 participants	0 participants	0 participants	—
Number Of Subjects With Unsolicited Adverse Events (AEs). AEs Leading to Death	0 participants	0 participants	0 participants	0 participants	—
Number Of Subjects With Unsolicited Adverse Events (AEs). AEs Leading to Withdrawal	0 participants	1 participants	1 participants	0 participants	—
Number Of Subjects With Unsolicited Adverse Events (AEs). Medically Attended AEs	13 participants	26 participants	39 participants	18 participants	—

SECONDARY outcome

Timeframe: From Day 1 until Day 7 after any vaccination.

Population: Analysis was done on Solicited Safety Set (all subjects in the exposed set with any solicited AE data).

Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.

Outcome measures

Outcome measures
Measure	CompDef n=28 Participants Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=100 Participants Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=128 Participants Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=74 Participants Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total n=202 Participants Total of subjects
Number of Subjects Reporting Solicited Local and Systemic AEs. Any (< 6 years; N=12,9,21,13,34)	12 participants	8 participants	20 participants	13 participants	33 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Any Local (< 6 years; N=12,9,21,13,34)	12 participants	6 participants	18 participants	12 participants	30 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Any Systemic (< 6 years; N=12,9,21,13,34)	11 participants	6 participants	17 participants	12 participants	29 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Any (≥ 6 years)	27 participants	98 participants	125 participants	74 participants	199 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Any Local (≥ 6 years)	26 participants	98 participants	124 participants	74 participants	198 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Any Systemic (≥ 6 years)	21 participants	75 participants	96 participants	60 participants	156 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Erythema (< 6 years; N=12,9,21,13,34)	7 participants	4 participants	11 participants	6 participants	17 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Induration (< 6 years; N=12,9,21,13,34)	5 participants	4 participants	9 participants	5 participants	14 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Swelling (< 6 years; N=12,9,21,13,34)	6 participants	4 participants	10 participants	6 participants	16 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Tenderness (<6 years; N=12,9,21,13,34)	12 participants	6 participants	18 participants	12 participants	30 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Change in Eating Habits (<6 years;N=12,9,21,13,34)	5 participants	1 participants	6 participants	8 participants	14 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Diarrhea (< 6 years; N=12,9,21,13,34)	5 participants	3 participants	8 participants	3 participants	11 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Irritability (< 6 years; N=12,9,21,13,34)	6 participants	2 participants	8 participants	9 participants	17 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Persistent Crying (< 6 years; N=12,9,21,13,34)	2 participants	2 participants	4 participants	6 participants	10 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Rash (< 6 years; N=12,9,21,13,34)	3 participants	0 participants	3 participants	0 participants	3 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Sleepiness (< 6 years; N=12,9,21,13,34)	7 participants	3 participants	10 participants	5 participants	15 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Vomiting (< 6 years; N=12,9,21,13,34)	2 participants	0 participants	2 participants	0 participants	2 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Fever (≥38°C) (< 6 years; N=12,9,21,13,34)	3 participants	1 participants	4 participants	4 participants	8 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Prevention Pain/Fever (<6 years; N=12,9,21,13,34)	5 participants	1 participants	6 participants	4 participants	10 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Treat. P/F (< 6 years; N=12,9,21,13,34)	5 participants	3 participants	8 participants	11 participants	19 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Erythema (≥ 6 years)	7 participants	19 participants	26 participants	27 participants	53 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Induration (≥ 6 years)	11 participants	27 participants	38 participants	19 participants	57 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Swelling (≥ 6 years)	8 participants	24 participants	32 participants	24 participants	56 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Pain (≥ 6 years)	25 participants	97 participants	122 participants	71 participants	193 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Arthralgia (≥ 6 years)	7 participants	25 participants	32 participants	18 participants	50 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Fatigue (≥ 6 years)	11 participants	55 participants	66 participants	46 participants	112 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Headache (≥ 6 years)	11 participants	47 participants	58 participants	35 participants	93 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Myalgia (≥ 6 years; N=28,100,128,73,201)	8 participants	31 participants	39 participants	27 participants	66 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Nausea (≥ 6 years)	7 participants	28 participants	35 participants	15 participants	50 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Rash (≥ 6 years)	7 participants	9 participants	16 participants	6 participants	22 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Fever (≥ 38°C) (≥ 6 years)	6 participants	6 participants	12 participants	5 participants	17 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Prev. Pain/Fever (≥ 6 years)	5 participants	9 participants	14 participants	15 participants	29 participants
Number of Subjects Reporting Solicited Local and Systemic AEs. Treat. Pain/Fever (≥ 6 years)	14 participants	39 participants	53 participants	38 participants	91 participants

Adverse Events

CompDef

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Asplenia

Serious events: 5 serious events

Other events: 106 other events

Deaths: 0 deaths

CompDef + Asplenia

Serious events: 6 serious events

Other events: 145 other events

Deaths: 0 deaths

Healthy

Serious events: 0 serious events

Other events: 87 other events

Deaths: 0 deaths

Total

Serious events: 6 serious events

Other events: 232 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CompDef n=40 participants at risk Subjects aged ≥ 2 to ≤17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=110 participants at risk Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=150 participants at risk Subjects aged ≥ 2 to ≤17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=87 participants at risk Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total n=237 participants at risk Total number of Subjects
Cardiac disorders INTRACARDIAC THROMBUS	0.00% 0/40 • Throughout the entire study period (Day 1 to Day 91)	0.91% 1/110 • Throughout the entire study period (Day 1 to Day 91)	0.67% 1/150 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/87 • Throughout the entire study period (Day 1 to Day 91)	0.42% 1/237 • Throughout the entire study period (Day 1 to Day 91)
Infections and infestations APPENDICITIS	0.00% 0/40 • Throughout the entire study period (Day 1 to Day 91)	0.91% 1/110 • Throughout the entire study period (Day 1 to Day 91)	0.67% 1/150 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/87 • Throughout the entire study period (Day 1 to Day 91)	0.42% 1/237 • Throughout the entire study period (Day 1 to Day 91)
Infections and infestations GASTROENTERITIS SALMONELLA	0.00% 0/40 • Throughout the entire study period (Day 1 to Day 91)	0.91% 1/110 • Throughout the entire study period (Day 1 to Day 91)	0.67% 1/150 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/87 • Throughout the entire study period (Day 1 to Day 91)	0.42% 1/237 • Throughout the entire study period (Day 1 to Day 91)
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	2.5% 1/40 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/110 • Throughout the entire study period (Day 1 to Day 91)	0.67% 1/150 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/87 • Throughout the entire study period (Day 1 to Day 91)	0.42% 1/237 • Throughout the entire study period (Day 1 to Day 91)
Infections and infestations TONSILLITIS	0.00% 0/40 • Throughout the entire study period (Day 1 to Day 91)	0.91% 1/110 • Throughout the entire study period (Day 1 to Day 91)	0.67% 1/150 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/87 • Throughout the entire study period (Day 1 to Day 91)	0.42% 1/237 • Throughout the entire study period (Day 1 to Day 91)
Injury, poisoning and procedural complications CONCUSSION	0.00% 0/40 • Throughout the entire study period (Day 1 to Day 91)	0.91% 1/110 • Throughout the entire study period (Day 1 to Day 91)	0.67% 1/150 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/87 • Throughout the entire study period (Day 1 to Day 91)	0.42% 1/237 • Throughout the entire study period (Day 1 to Day 91)
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISORDER	0.00% 0/40 • Throughout the entire study period (Day 1 to Day 91)	0.91% 1/110 • Throughout the entire study period (Day 1 to Day 91)	0.67% 1/150 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/87 • Throughout the entire study period (Day 1 to Day 91)	0.42% 1/237 • Throughout the entire study period (Day 1 to Day 91)

Other adverse events

Other adverse events
Measure	CompDef n=40 participants at risk Subjects aged ≥ 2 to ≤17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	Asplenia n=110 participants at risk Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	CompDef + Asplenia n=150 participants at risk Subjects aged ≥ 2 to ≤17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	Healthy n=87 participants at risk Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	Total n=237 participants at risk Total number of Subjects
Gastrointestinal disorders DIARRHOEA	12.5% 5/40 • Throughout the entire study period (Day 1 to Day 91)	3.6% 4/110 • Throughout the entire study period (Day 1 to Day 91)	6.0% 9/150 • Throughout the entire study period (Day 1 to Day 91)	4.6% 4/87 • Throughout the entire study period (Day 1 to Day 91)	5.5% 13/237 • Throughout the entire study period (Day 1 to Day 91)
Gastrointestinal disorders NAUSEA	17.5% 7/40 • Throughout the entire study period (Day 1 to Day 91)	25.5% 28/110 • Throughout the entire study period (Day 1 to Day 91)	23.3% 35/150 • Throughout the entire study period (Day 1 to Day 91)	17.2% 15/87 • Throughout the entire study period (Day 1 to Day 91)	21.1% 50/237 • Throughout the entire study period (Day 1 to Day 91)
Gastrointestinal disorders VOMITING	7.5% 3/40 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/110 • Throughout the entire study period (Day 1 to Day 91)	2.0% 3/150 • Throughout the entire study period (Day 1 to Day 91)	0.00% 0/87 • Throughout the entire study period (Day 1 to Day 91)	1.3% 3/237 • Throughout the entire study period (Day 1 to Day 91)
General disorders CRYING	5.0% 2/40 • Throughout the entire study period (Day 1 to Day 91)	1.8% 2/110 • Throughout the entire study period (Day 1 to Day 91)	2.7% 4/150 • Throughout the entire study period (Day 1 to Day 91)	6.9% 6/87 • Throughout the entire study period (Day 1 to Day 91)	4.2% 10/237 • Throughout the entire study period (Day 1 to Day 91)
General disorders FATIGUE	27.5% 11/40 • Throughout the entire study period (Day 1 to Day 91)	50.0% 55/110 • Throughout the entire study period (Day 1 to Day 91)	44.0% 66/150 • Throughout the entire study period (Day 1 to Day 91)	52.9% 46/87 • Throughout the entire study period (Day 1 to Day 91)	47.3% 112/237 • Throughout the entire study period (Day 1 to Day 91)
General disorders INJECTION SITE ERYTHEMA	37.5% 15/40 • Throughout the entire study period (Day 1 to Day 91)	20.9% 23/110 • Throughout the entire study period (Day 1 to Day 91)	25.3% 38/150 • Throughout the entire study period (Day 1 to Day 91)	39.1% 34/87 • Throughout the entire study period (Day 1 to Day 91)	30.4% 72/237 • Throughout the entire study period (Day 1 to Day 91)
General disorders INJECTION SITE INDURATION	42.5% 17/40 • Throughout the entire study period (Day 1 to Day 91)	29.1% 32/110 • Throughout the entire study period (Day 1 to Day 91)	32.7% 49/150 • Throughout the entire study period (Day 1 to Day 91)	29.9% 26/87 • Throughout the entire study period (Day 1 to Day 91)	31.6% 75/237 • Throughout the entire study period (Day 1 to Day 91)
General disorders INJECTION SITE PAIN	92.5% 37/40 • Throughout the entire study period (Day 1 to Day 91)	93.6% 103/110 • Throughout the entire study period (Day 1 to Day 91)	93.3% 140/150 • Throughout the entire study period (Day 1 to Day 91)	95.4% 83/87 • Throughout the entire study period (Day 1 to Day 91)	94.1% 223/237 • Throughout the entire study period (Day 1 to Day 91)
General disorders INJECTION SITE SWELLING	35.0% 14/40 • Throughout the entire study period (Day 1 to Day 91)	25.5% 28/110 • Throughout the entire study period (Day 1 to Day 91)	28.0% 42/150 • Throughout the entire study period (Day 1 to Day 91)	36.8% 32/87 • Throughout the entire study period (Day 1 to Day 91)	31.2% 74/237 • Throughout the entire study period (Day 1 to Day 91)
General disorders PYREXIA	25.0% 10/40 • Throughout the entire study period (Day 1 to Day 91)	6.4% 7/110 • Throughout the entire study period (Day 1 to Day 91)	11.3% 17/150 • Throughout the entire study period (Day 1 to Day 91)	11.5% 10/87 • Throughout the entire study period (Day 1 to Day 91)	11.4% 27/237 • Throughout the entire study period (Day 1 to Day 91)
Musculoskeletal and connective tissue disorders ARTHRALGIA	17.5% 7/40 • Throughout the entire study period (Day 1 to Day 91)	22.7% 25/110 • Throughout the entire study period (Day 1 to Day 91)	21.3% 32/150 • Throughout the entire study period (Day 1 to Day 91)	20.7% 18/87 • Throughout the entire study period (Day 1 to Day 91)	21.1% 50/237 • Throughout the entire study period (Day 1 to Day 91)
Musculoskeletal and connective tissue disorders MYALGIA	20.0% 8/40 • Throughout the entire study period (Day 1 to Day 91)	28.2% 31/110 • Throughout the entire study period (Day 1 to Day 91)	26.0% 39/150 • Throughout the entire study period (Day 1 to Day 91)	31.0% 27/87 • Throughout the entire study period (Day 1 to Day 91)	27.8% 66/237 • Throughout the entire study period (Day 1 to Day 91)
Nervous system disorders HEADACHE	27.5% 11/40 • Throughout the entire study period (Day 1 to Day 91)	43.6% 48/110 • Throughout the entire study period (Day 1 to Day 91)	39.3% 59/150 • Throughout the entire study period (Day 1 to Day 91)	40.2% 35/87 • Throughout the entire study period (Day 1 to Day 91)	39.7% 94/237 • Throughout the entire study period (Day 1 to Day 91)
Nervous system disorders SOMNOLENCE	17.5% 7/40 • Throughout the entire study period (Day 1 to Day 91)	2.7% 3/110 • Throughout the entire study period (Day 1 to Day 91)	6.7% 10/150 • Throughout the entire study period (Day 1 to Day 91)	5.7% 5/87 • Throughout the entire study period (Day 1 to Day 91)	6.3% 15/237 • Throughout the entire study period (Day 1 to Day 91)
Psychiatric disorders EATING DISORDER	12.5% 5/40 • Throughout the entire study period (Day 1 to Day 91)	0.91% 1/110 • Throughout the entire study period (Day 1 to Day 91)	4.0% 6/150 • Throughout the entire study period (Day 1 to Day 91)	9.2% 8/87 • Throughout the entire study period (Day 1 to Day 91)	5.9% 14/237 • Throughout the entire study period (Day 1 to Day 91)
Psychiatric disorders IRRITABILITY	17.5% 7/40 • Throughout the entire study period (Day 1 to Day 91)	1.8% 2/110 • Throughout the entire study period (Day 1 to Day 91)	6.0% 9/150 • Throughout the entire study period (Day 1 to Day 91)	10.3% 9/87 • Throughout the entire study period (Day 1 to Day 91)	7.6% 18/237 • Throughout the entire study period (Day 1 to Day 91)
Skin and subcutaneous tissue disorders RASH	25.0% 10/40 • Throughout the entire study period (Day 1 to Day 91)	8.2% 9/110 • Throughout the entire study period (Day 1 to Day 91)	12.7% 19/150 • Throughout the entire study period (Day 1 to Day 91)	6.9% 6/87 • Throughout the entire study period (Day 1 to Day 91)	10.5% 25/237 • Throughout the entire study period (Day 1 to Day 91)

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER