Clinical trial NCT01214850: Novartis Vaccine and Diagnostics Carriage Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: N. Meningitidis Carriage
Keywords: Meningococcal vaccines
Meningococcal B
Meningococcal ACWY serogroups
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 2968
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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 ≥38ºC) 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 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.

Primary outcomes:
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
timeFrame: 61 days (31 days after receiving the second injection)
measure: Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination
timeFrame: 31 days after MenACWY-CRM injection
Secondary outcomes:
measure: Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination
timeFrame: Up to 361 days after vaccination
measure: 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
timeFrame: Up to 361 days after vaccination
measure: 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
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination
timeFrame: Up to 361 days after vaccination
measure: The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV
timeFrame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
measure: The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM
timeFrame: Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)
measure: The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine
timeFrame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
measure: The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine
timeFrame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
measure: Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination
timeFrame: Up to 361 days after vaccination
measure: Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers
timeFrame: Up to 12 months after vaccination
measure: 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
timeFrame: Up to 361 days after vaccination
measure: The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
timeFrame: Up to 361 days after vaccination
measure: 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.
timeFrame: Up to 361 days after vaccination
measure: The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
timeFrame: Up to 361 days after vaccination
measure: 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.
timeFrame: 61 days
measure: 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
timeFrame: Up to 361 days after vaccination
measure: 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.
timeFrame: Up to 361 days after vaccination
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group
timeFrame: Day 1 through day 7 after any vaccination
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
facility: Clinical Research Center, University of Surrey
state: England
city: Bristol, England
country: United Kingdom
facility: Bristol Children's Vaccine Center, University of Bristol,
city: Liverpool, England
country: United Kingdom
facility: Royal Liverpool and Broad Green University Hospital Trust
city: London, England
country: United Kingdom
facility: St Georges Vaccine Institute, St Georges, University of London
city: Manchester, England
country: United Kingdom
facility: Manchester Welcome Trust Clinical Research Facility, University of Manchester
city: Middlesbrough, England
country: United Kingdom
facility: The James Cook University Hospital
city: Nottingham, England
country: United Kingdom
facility: Cripps Health Centre, University Park
city: Oxford, England
country: United Kingdom
facility: University of Oxford, Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine
city: Sheffield, England
country: United Kingdom
facility: Clinical Research Facility, Royal Hallamshire Hospital
city: Southampton, England
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility, University of Southampton
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.