Trials Sponsors Conditions Drugs Pricing

Conditions

N. Meningitidis Carriage

Keywords

Meningococcal vaccinesMeningococcal BMeningococcal 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

Interventions

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

rMenB+OMV

MenACWY-CRM conjugate vaccineBiological

MenACWY

Eligibility Criteria

Age18 Years - 24 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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;

Sponsors & Collaborators

Novartis Vaccines
Industrylead

Study Sites (10)

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

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: 25247300DERIVED
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

MeSH Terms

Interventions

Japanese Encephalitis Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title: Posting Director
Organization: Novartis Vaccines and Diagnostics

Study Officials

Novartis Vaccines and Diagnostics
Novartis Vaccines
STUDY CHAIR

Publication Agreements

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

Enrollment

2,968 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

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.

Novartis Vaccine and Diagnostics Carriage Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (33)

Study Arms (3)

rMenB+OMV

MenACWY

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (33)

Study Arms (3)

rMenB+OMV

MenACWY

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations