Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
NCT ID: NCT01165242
Last Updated: 2018-06-26
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
PHASE2
1013 participants
INTERVENTIONAL
2010-08-19
2011-07-29
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.
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds
NCT01154088
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.
NCT00454909
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
NCT01235975
Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects
NCT01641042
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults
NCT00715910
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
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Subjects were vaccinated with vaccine GSK134612 Lot A
Meningococcal vaccine GSK 134612
One intramuscular injection
Group B
Subjects were vaccinated with vaccine GSK134612 Lot B
Meningococcal vaccine GSK 134612
One intramuscular injection
Group C
Subjects were vaccinated with Menactra®
Menactra®
One intramuscular injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meningococcal vaccine GSK 134612
One intramuscular injection
Menactra®
One intramuscular injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects whom the investigator believes that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* A male or female between, and including, 10 and 25 years of age at the time of the vaccination.
* Written informed consent obtained from the subject/from the parent or Legally Acceptable Representative(s) of the subject. Assent will be obtained from subjects who are still legally minors in line with local rules and regulations.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Previously completed routine childhood vaccinations to the best of subject's/Legally Acceptable Representative(s)'s knowledge.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination, and
* has agreed to continue adequate contraception for 2 months after vaccination.
Exclusion Criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone \<10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed.)
* Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine.
* Previous vaccination with meningococcal polysaccharide or conjugate vaccine.
* Previous vaccination with vaccine components within the last month.
* History of meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* History of allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex.
* History of any neurologic disorders, including Guillain-Barré Syndrome.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrollment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female.
* History of chronic alcohol consumption and/or drug abuse.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
* Child in care.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
10 Years
25 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
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.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Paramount, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Santa Rosa, California, United States
GSK Investigational Site
Longmont, Colorado, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Woodstock, Georgia, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Nicholasville, Kentucky, United States
GSK Investigational Site
Columbia, Maryland, United States
GSK Investigational Site
Stevensville, Michigan, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
Albany, Oregon, United States
GSK Investigational Site
Carnegie, Pennsylvania, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Hermitage, Pennsylvania, United States
GSK Investigational Site
Greer, South Carolina, United States
GSK Investigational Site
Simpsonville, South Carolina, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Coquitlam, British Columbia, Canada
GSK Investigational Site
Surrey, British Columbia, Canada
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Brampton, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Woodstock, Ontario, Canada
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.
Halperin SA, Baine Y, Domachowske JB, Aggarwal N, Simon M, Langley JM, McNeil SA, Friedland LR, Bianco V, Baccarini CI, Miller JM. Comparison of the Safety and Immunogenicity of a Novel Quadrivalent Meningococcal ACWY-Tetanus Toxoid Conjugate Vaccine and a Marketed Quadrivalent Meningococcal ACWY-Diphtheria Toxoid Conjugate Vaccine in Healthy Individuals 10-25 Years of Age. J Pediatric Infect Dis Soc. 2014 Mar;3(1):33-42. doi: 10.1093/jpids/pit058. Epub 2013 Oct 17.
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
114249
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.