N. Meningitidis CarriagePhase 3NCT01214850

Novartis Vaccine and Diagnostics Carriage Trial

A Phase 3 study testing Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ), MenACWY-CRM conjugate vaccine and Japanese Encephalitis vaccine in people with N. Meningitidis Carriage, run by Novartis Vaccines at 10 sites in United Kingdom.

Completed

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

Official record

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Trial summary

The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population. Read more about this study

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: N. Meningitidis Carriage
What is being tested?: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ), MenACWY-CRM conjugate vaccine and Japanese Encephalitis vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,968 participants
Where: 10 sitesUnited Kingdom
Study dates: Sep 2010to Jan 2012
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 18 to 24 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment;
Subjects who were available for all the visits scheduled in the study;
Subjects who were in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Who cannot join

History of any serogroup B meningococcal vaccine administration;
Current or previous, confirmed or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
Significant acute or chronic infection within the previous 7 days or fever (defined as oral temperature ≥38ºC) within the previous day;
Antibiotics within 3 days (72 hours) prior to enrollment;
Pregnancy or nursing (breastfeeding) mothers;

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Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the 12 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence were considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry;
Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body were allowed]; use of immunostimulants;
Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
Participation in another clinical trial within the last 90 days or planned for during study;
Family members and household members of research staff;
Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United Kingdom10 sites

Bristol Children's Vaccine Center, University of Bristol,
Bristol, England
Royal Liverpool and Broad Green University Hospital Trust
Liverpool, England
St Georges Vaccine Institute, St Georges, University of London
London, England
Manchester Welcome Trust Clinical Research Facility, University of Manchester
Manchester, England
The James Cook University Hospital
Middlesbrough, England
Cripps Health Centre, University Park
Nottingham, England
University of Oxford, Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine
Oxford, England
Clinical Research Facility, Royal Hallamshire Hospital
Sheffield, England
Wellcome Trust Clinical Research Facility, University of Southampton
Southampton, England
Clinical Research Center, University of Surrey
Surrey, England

Other trials in United Kingdom

About this study

Official title: A Phase 3 Observer Blind Randomized, Multi-center, Controlled Study to Evaluate the Effect of Novartis Vaccine's Meningococcal B Recombinant and MenACWY Conjugate Vaccines on Pharyngeal Carriage of N. Meningitidis in Young Adults

The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population.

Conditions: N. Meningitidis Carriage
Being tested: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ), MenACWY-CRM conjugate vaccine, Japanese Encephalitis vaccine
Keywords: Meningococcal vaccines, Meningococcal B, Meningococcal ACWY serogroups

What participants receive

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

Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)Biological
MenACWY-CRM conjugate vaccineBiological
Japanese Encephalitis vaccineBiological
Also called IXIARO

Study groups in NCT01214850
Study group	Role	What they receive
rMenB+OMV	Experimental	Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart Receives: Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)
MenACWY	Experimental	Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart Receives: Biological: MenACWY-CRM conjugate vaccine
Control	Active comparator	Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart Receives: Biological: Japanese Encephalitis vaccine

What is being measured

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

Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.
Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.
Measured: 61 days (31 days after receiving the second injection)
Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination
The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Measured: 31 days after MenACWY-CRM injection

Secondary outcomes (33)

Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination
The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination
Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination
Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination
Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.
Measured: Up to 361 days after vaccination
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV
The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.
Measured: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM
The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.
Measured: Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine
The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.
Measured: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine
The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.
Measured: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination
The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).
H44/76, 5/99 and NZ98/254 are strains in serogroup B.
Measured: Up to 361 days after vaccination
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers
The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.
Measured: Up to 12 months after vaccination
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group
The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
Measured: Up to 361 days after vaccination
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
Measured: Up to 361 days after vaccination
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested.
Measured: Up to 361 days after vaccination
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.
Serogroups A and W were not analysed.
Measured: Up to 361 days after vaccination
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.
The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.
Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Analysis was not done for serogroups A and W.
Measured: 61 days
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group
The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
Analysis was not done for serogroups A and W.
Measured: Up to 361 days after vaccination
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.
The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.
Analysis was not done for serogroups A and W.
Measured: Up to 361 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group
The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.
Measured: Day 1 through 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.

Sep 2010Jan 2012

First posted5 Oct 2010 (estimated)
Study startSep 2010
Primary completionJan 2012
Study completionJan 2012

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 (2)Papers the sponsor has linked to this study.
Other trials for N. Meningitidis CarriageStudies 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 2,968 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01214850
Sponsor's protocol ID: V72_29
Status last verified: Mar 2016
First submitted: 30 Sep 2010
Last updated: 21 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Lemee L, Hong E, Etienne M, Deghmane AE, Delbos V, Terrade A, Berthelot G, Caron F, Taha MK. Genetic diversity and levels of expression of factor H binding protein among carriage isolates of Neisseria meningitidis. PLoS One. 2014 Sep 23;9(9):e107240. doi: 10.1371/journal.pone.0107240. eCollection 2014.
PubMed 25247300
Read RC, Baxter D, Chadwick DR, Faust SN, Finn A, Gordon SB, Heath PT, Lewis DJ, Pollard AJ, Turner DP, Bazaz R, Ganguli A, Havelock T, Neal KR, Okike IO, Morales-Aza B, Patel K, Snape MD, Williams J, Gilchrist S, Gray SJ, Maiden MC, Toneatto D, Wang H, McCarthy M, Dull PM, Borrow R. Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. Lancet. 2014 Dec 13;384(9960):2123-31. doi: 10.1016/S0140-6736(14)60842-4. Epub 2014 Aug 18.
PubMed 25145775

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Observer Blind Randomized, Multi-center, Controlled Study to Evaluate the Effect of Novartis Vaccine's Meningococcal B Recombinant and MenACWY Conjugate Vaccines on Pharyngeal Carriage of N. Meningitidis in Young Adults
ClinicalTrials.gov ID: NCT01214850
Acronym / sponsor ID: V72_29
Conditions: N. Meningitidis Carriage
Keywords: Meningococcal vaccines, Meningococcal B, Meningococcal ACWY serogroups
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,968 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 5 Oct 2010 (estimated)
Results: Posted 23 Jan 2014

Clinical summary

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

The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
rMenB+OMV	Experimental	Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
MenACWY	Experimental	Biological: MenACWY-CRM conjugate vaccineSubjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Control	Active comparator	Biological: Japanese Encephalitis vaccineSubjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment;
Subjects who were available for all the visits scheduled in the study;
Subjects who were in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Key exclusion criteria (14 listed)

History of any serogroup B meningococcal vaccine administration;
Current or previous, confirmed or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
Significant acute or chronic infection within the previous 7 days or fever (defined as oral temperature ≥38ºC) within the previous day;
Antibiotics within 3 days (72 hours) prior to enrollment;

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
Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)	Biological	rMenB+OMV
MenACWY-CRM conjugate vaccine	Biological	MenACWY
Japanese Encephalitis vaccineAlso: IXIARO	Biological	Control

Primary outcome

Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination
Time frame: 61 days (31 days after receiving the second injection)
Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported. Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.
Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination
Time frame: 31 days after MenACWY-CRM injection
The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.

33 secondary outcomes

Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination
Time frame: Up to 361 days after vaccination
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV
Time frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM
Time frame: Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine
Time frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine
Time frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination
Time frame: Up to 361 days after vaccination
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers
Time frame: Up to 12 months after vaccination
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group
Time frame: Up to 361 days after vaccination
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
Time frame: Up to 361 days after vaccination
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
Time frame: Up to 361 days after vaccination
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
Time frame: Up to 361 days after vaccination
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.
Time frame: 61 days
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group
Time frame: Up to 361 days after vaccination
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.
Time frame: Up to 361 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group
Time frame: Day 1 through day 7 after any vaccination

Results and safety

Results posted to the registry on 23 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rMenB+OMV	979	796
MenACWY	988	844
Control	987	826

Primary outcome: Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination

Time frame: 61 days (31 days after receiving the second injection). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	rMenB+OMV n = 974	Control n = 984
Baseline	8 (6 to 10)	7 (6 to 9)
Month 2 (N= 916, 928)	9 (8 to 12)	8 (6 to 10)

rMenB+OMV vs Control: Odds Ratio (OR): 1.185 (95% CI 0.809 to 1.737), p = 0.3828, Regression, Logistic

Population analysed: Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.

Primary outcome: Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination

Time frame: 31 days after MenACWY-CRM injection. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenACWY n = 981	Control n = 984
Baseline	6 (5 to 8)	5 (4 to 7)
Month 1 (N=956, 947)	6 (5 to 8)	6 (5 to 8)

MenACWY vs Control: Odds Ratio (OR): 0.840 (95% CI 0.555 to 1.273), Regression, Logistic

Population analysed: Analysis was done on the MITT dataset (Pharyngeal carriage)

33 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rMenB+OMV	31 of 974 (3.2%)	200 of 974 (20.5%)	Not reported
MenACWY	26 of 984 (2.6%)	186 of 984 (18.9%)	Not reported
Control	20 of 985 (2%)	172 of 985 (17.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25247300Lemee L, Hong E, Etienne M, Deghmane AE, Delbos V, Terrade A, Berthelot G, Caron F, Taha MK. Genetic diversity and levels of expression of factor H binding protein among carriage isolates of Neisseria meningitidis. PLoS One. 2014 Sep 23;9(9):e107240. doi: 10.1371/journal.pone.0107240. eCollection 2014.
Derived from this study: PubMed 25145775Read RC, Baxter D, Chadwick DR, Faust SN, Finn A, Gordon SB, Heath PT, Lewis DJ, Pollard AJ, Turner DP, Bazaz R, Ganguli A, Havelock T, Neal KR, Okike IO, Morales-Aza B, Patel K, Snape MD, Williams J, Gilchrist S, Gray SJ, Maiden MC, Toneatto D, Wang H, McCarthy M, Dull PM, Borrow R. Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. Lancet. 2014 Dec 13;384(9960):2123-31. doi: 10.1016/S0140-6736(14)60842-4. Epub 2014 Aug 18.

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 and Diagnostics study chair

Novartis Vaccines

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 14 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom. 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 23 Jan 2014). 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 Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination (time frame: 61 days (31 days after receiving the second injection)). The study lists 2 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 NCT01214850, which also lists 2 linked publications.

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 21 Apr 2016.