Novartis Vaccine and Diagnostics Carriage Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01214850
First received: September 30, 2010
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
N. Meningitidis Carriage
Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)
Biological: MenACWY-CRM conjugate vaccine
Biological: Japanese Encephalitis vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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 is 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 2968
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rMenB+OMV
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)
Experimental: MenACWY
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
Biological: MenACWY-CRM conjugate vaccine
Active Comparator: Control
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Biological: Japanese Encephalitis vaccine
Other Name: IXIARO

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 38C) within the previous day;
  • Antibiotics within 3 days (72 hours) prior to enrollment;
  • Pregnancy or nursing (breastfeeding) mothers;
  • 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 are 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 is allowed]; 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214850

Locations
United Kingdom
Clinical Research Center, University of Surrey
Surrey, England, United Kingdom
Bristol Children's Vaccine Center, University of Bristol,
Bristol, England, United Kingdom
Royal Liverpool and Broad Green University Hospital Trust
Liverpool, England, United Kingdom
St Georges Vaccine Institute, St Georges, University of London
London, England, United Kingdom
Manchester Welcome Trust Clinical Research Facility, University of Manchester
Manchester, England, United Kingdom
The James Cook University Hospital
Middlesbrough, England, United Kingdom
Cripps Health Centre, University Park
Nottingham, England, United Kingdom
University of Oxford, Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine
Oxford, England, United Kingdom
Clinical Research Facility, Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Wellcome Trust Clinical Research Facility, University of Southampton
Southampton, England, United Kingdom
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01214850     History of Changes
Other Study ID Numbers: V72_29
Study First Received: September 30, 2010
Results First Received: September 4, 2013
Last Updated: September 5, 2014
Health Authority: European Union: European Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Meningococcal vaccines
Meningococcal B
Meningococcal ACWY serogroups

ClinicalTrials.gov processed this record on October 21, 2014