Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2968 participants
INTERVENTIONAL
2010-09-30
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
NCT01453348
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
NCT00518180
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
NCT01466387
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
NCT00465816
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
NCT01424644
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rMenB+OMV
Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)
MenACWY
Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
MenACWY-CRM conjugate vaccine
Control
Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Japanese Encephalitis vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)
MenACWY-CRM conjugate vaccine
Japanese Encephalitis vaccine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
24 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Vaccines
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Vaccines and Diagnostics
Role: STUDY_CHAIR
Novartis Vaccines
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V72_29
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.