Novartis Vaccine and Diagnostics Carriage Trial

NCT01214850 | Completed Phase 3 Results

• 1 other identifier: V72_29
• Study Type: interventional
• Target: 2,968
• Locations: 1 country
• Sites: 10

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.

Conditions

N. Meningitidis Carriage

Keywords

Meningococcal vaccines; Meningococcal B; Meningococcal ACWY serogroups

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  Up to 361 days after vaccination

Study Arms (3)

rMenB+OMV

EXPERIMENTAL

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)

MenACWY

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart

Biological: Japanese Encephalitis vaccine

Interventions

Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ) BIOLOGICAL

rMenB+OMV

MenACWY-CRM conjugate vaccine BIOLOGICAL

MenACWY

Japanese Encephalitis vaccine BIOLOGICAL

Also known as: IXIARO

Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (10)

Clinical Research Center, University of Surrey

Surrey, England, United Kingdom

Location

Bristol Children's Vaccine Center, University of Bristol,

Bristol, England, United Kingdom

Location

Royal Liverpool and Broad Green University Hospital Trust

Liverpool, England, United Kingdom

Location

St Georges Vaccine Institute, St Georges, University of London

London, England, United Kingdom

Location

Manchester Welcome Trust Clinical Research Facility, University of Manchester

Manchester, England, United Kingdom

Location

The James Cook University Hospital

Middlesbrough, England, United Kingdom

Location

Cripps Health Centre, University Park

Nottingham, England, United Kingdom

Location

University of Oxford, Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine

Oxford, England, United Kingdom

Location

Clinical Research Facility, Royal Hallamshire Hospital

Sheffield, England, United Kingdom

Location

Wellcome Trust Clinical Research Facility, University of Southampton

Southampton, England, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 25247300 DERIVED

• 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.

  PMID: 25145775 DERIVED

MeSH Terms

Interventions

Japanese Encephalitis Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 5, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 21, 2016
• Results First Posted: January 23, 2014

Record last verified: 2016-03

Locations

GB (10)