Meningococcal DiseasePhase 3NCT02141516

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

A Phase 3 study testing rMenB+OMV in people with Meningococcal Disease, run by Novartis at 20 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease
What is being tested?: rMenB+OMV
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 239 participants
Where: 20 sitesin 5 countries
Study dates: May 2014to Mar 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects aged 2 to 17 years (inclusive) at enrollment
weighing at least 13 Kg at the time of enrollment
Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies
Subjects at risk of meningococcal disease because of functional or anatomic asplenia
Inclusion criterion applicable to Group C - healthy subjects

Who cannot join

History of any previous immunization with a meningococcal B vaccine
History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine
Known HIV infection
History of any progressive or severe neurologic disorder or seizure disorder
Contraindication to intramuscular injection or blood drawn
Females who are pregnant, planning a pregnancy or nursing (breastfeeding)

Show all 11Show fewer

Females of childbearing potential who have not used or do not plan to use acceptable birth control measures
History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects
Previous known or suspected disease caused by N. meningitidis in the last year.
Previous known or suspected disease caused by N. meningitidis
Known or suspected impairment/alteration of the immune system

Trial locations and contacts

20 sites in 5 countries.

Country

City, postcode or hospital

20 sites in 5 countries

Italy5 sites

12, Novartis Investigational Site
Florence, 50139
11, Novartis Investigational Site
Genova, 16132
10, Novartis Investigational Site
Milan, 20122
14, Novartis Investigational Site
Padova, 35128
13, Novartis Investigational Site
Roma, 00165

Other trials in Italy

Spain5 sites

21, Novartis Investigational Site
Barcelona, 08035
22, Novartis Investigational Site
Madrid, 28046
23, Novartis Investigational Site
Madrid, 46026
20, Novartis Investigational Site
Santiago de Compostela, 15706
24, Novartis Investigational Site
Valencia, 46026

Other trials in Spain

United Kingdom4 sites

53, Novartis Investigational Site
London, WC1N 3JH
52, Novartis Investigational Site
Manchester, M13 9WL
50, Novartis Investigational Site
Oxford, OX3 7LE
51, Novartis Investigational Site
Southampton, SO16 6YD

Other trials in United Kingdom

Poland3 sites

31, Novartis Investigational Site
Krakow, 31-302
33, Novartis Investigational Site
Warsaw, 04-730
30, Novartis Investigational Site
Wroclaw, 50-345

Other trials in Poland

Russia3 sites

42, Novartis Investigational Site
Moscow, 117198
41, Novartis Investigational Site
Moscow, 117997
43, Novartis Investigational Site
Yekaterinburg, 620149

Other trials in Russia

About this study

Official title: A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls.

Conditions: Meningococcal Disease
Being tested: rMenB+OMV
Keywords: Meningitis, vaccination, complement deficiency, asplenia, splenic dysfunction
Medical subject headings: Meningococcal Infections, Meningitis, Hereditary Complement Deficiency Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rMenB+OMVBiological
2 doses of vaccine 2 months apart
rMenB+OMVBiological
2 doses of vaccine 2 months apart
rMenB+OMVBiological
2 doses of vaccine 2 months apart

Study groups in NCT02141516
Study group	Role	What they receive
Group A	Experimental	Complement deficiency Receives: Biological: rMenB+OMV
Group B	Experimental	asplenia/splenic dysfunction Receives: Biological: rMenB+OMV
Group C	Active comparator	age-matched healthy controls Receives: Biological: rMenB+OMV

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Mar 2015

First posted19 May 2014 (estimated)
Study startMay 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02141516
Sponsor's protocol ID: V72_62
Other IDs: 2013-002454-78
Status last verified: Jul 2016
First submitted: 15 May 2014
Last updated: 15 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Martinon-Torres F, Bernatowska E, Shcherbina A, Esposito S, Szenborn L, Marti MC, Hughes S, Faust SN, Gonzalez-Granado LI, Yu LM, D'Agostino D, Calabresi M, Toneatto D, Snape MD. Meningococcal B Vaccine Immunogenicity in Children With Defects in Complement and Splenic Function. Pediatrics. 2018 Sep;142(3):e20174250. doi: 10.1542/peds.2017-4250. Epub 2018 Aug 1.
PubMed 30068713

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Learn About the Safety of PENBRAYA During Pregnancy
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All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls.
ClinicalTrials.gov ID: NCT02141516
Acronym / sponsor ID: V72_62
Conditions: Meningococcal Disease
Keywords: Meningitis, vaccination, complement deficiency, asplenia, splenic dysfunction
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: May 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 19 May 2014 (estimated)
Results: Posted 15 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Biological: rMenB+OMVComplement deficiency
Group B	Experimental	Biological: rMenB+OMVasplenia/splenic dysfunction
Group C	Active comparator	Biological: rMenB+OMVage-matched healthy controls

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Subjects aged 2 to 17 years (inclusive) at enrollment
weighing at least 13 Kg at the time of enrollment
Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies
Subjects at risk of meningococcal disease because of functional or anatomic asplenia
Inclusion criterion applicable to Group C - healthy subjects

Key exclusion criteria (11 listed)

History of any previous immunization with a meningococcal B vaccine
History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine
Known HIV infection
History of any progressive or severe neurologic disorder or seizure disorder
Contraindication to intramuscular injection or blood drawn

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rMenB+OMV2 doses of vaccine 2 months apart	Biological	Group A
rMenB+OMV2 doses of vaccine 2 months apart	Biological	Group B
rMenB+OMV2 doses of vaccine 2 months apart	Biological	Group C

Primary outcome

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.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine)
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.
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
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.
Time frame: Day 91 (one month after the second dose of the study vaccine).
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.
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.
Time frame: Day 91 (one month after the second dose of the study vaccine).
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.
Number Of Subjects With Unsolicited Adverse Events (AEs).
Time frame: At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 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).

1 secondary outcome

Number of Subjects Reporting Solicited Local and Systemic AEs.
Time frame: From Day 1 until Day 7 after any vaccination.

Results and safety

Results posted to the registry on 15 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CompDef	40	40
Asplenia	112	107
Healthy	87	87

Primary outcome: 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.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine). Number (95% Confidence Interval). Unit: Percentage of Subjects

Measure	CompDef n = 39	Asplenia n = 106	CompDef + Asplenia n = 145	Healthy n = 85
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)

Population analysed: 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).

Primary outcome: Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).. Number (95% Confidence Interval). Unit: Percentage of Subjects

Measure	CompDef n = 40	Asplenia n = 107	CompDef + Asplenia n = 147	Healthy n = 87
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)

Population analysed: Analysis was done on Full Analysis Set

Primary outcome: Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).. Geometric mean (95% Confidence Interval). Unit: Ratios

Measure	CompDef n = 40	Asplenia n = 107	CompDef + Asplenia n = 147	Healthy n = 85
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)

Population analysed: Analysis was done on Full Analysis Set

Primary outcome: Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	CompDef n = 40	Asplenia n = 107	CompDef + Asplenia n = 147	Healthy n = 85
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)

Population analysed: Analysis was done on Full Analysis Set.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Throughout the entire study period (Day 1 to Day 91). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CompDef	1 of 40 (2.5%)	39 of 40 (97.5%)	Not reported
Asplenia	5 of 110 (4.5%)	106 of 110 (96.4%)	Not reported
CompDef + Asplenia	6 of 150 (4%)	145 of 150 (96.7%)	Not reported
Healthy	0 of 87 (0%)	87 of 87 (100%)	Not reported
Total	6 of 237 (2.5%)	232 of 237 (97.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30068713Martinon-Torres F, Bernatowska E, Shcherbina A, Esposito S, Szenborn L, Marti MC, Hughes S, Faust SN, Gonzalez-Granado LI, Yu LM, D'Agostino D, Calabresi M, Toneatto D, Snape MD. Meningococcal B Vaccine Immunogenicity in Children With Defects in Complement and Splenic Function. Pediatrics. 2018 Sep;142(3):e20174250. doi: 10.1542/peds.2017-4250. Epub 2018 Aug 1.

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Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines study chair

Novartis Vaccines

20 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rMenB+OMV in people with Meningococcal Disease, run by Novartis at 20 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy, Spain, United Kingdom, Poland, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02141516, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.