Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
1 other identifier
interventional
1,013
2 countries
32
Brief Summary
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2010
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2010
CompletedFirst Posted
Study publicly available on registry
July 19, 2010
CompletedStudy Start
First participant enrolled
August 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2011
CompletedResults Posted
Study results publicly available
June 8, 2017
CompletedJune 26, 2018
May 1, 2018
6 months
July 15, 2010
May 11, 2017
May 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
Vaccine response was defined as: * for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; * for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
One month after vaccination (Month 1)
Secondary Outcomes (9)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
Prior to (PRE) and one month after vaccination (Month 1)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
Prior to (PRE) and one month after vaccination (Month 1)
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Prior to (PRE) and one month after vaccination (Month 1)
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
One month after vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
During the 4-day (Days 0-3) post-vaccination period
- +4 more secondary outcomes
Study Arms (3)
Group A
EXPERIMENTALSubjects were vaccinated with vaccine GSK134612 Lot A
Group B
EXPERIMENTALSubjects were vaccinated with vaccine GSK134612 Lot B
Group C
ACTIVE COMPARATORSubjects were vaccinated with Menactra®
Interventions
Eligibility Criteria
You may qualify if:
- All subjects must satisfy ALL of the following criteria at study entry:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (32)
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
Sacramento, California, 95823, United States
GSK Investigational Site
Santa Rosa, California, 95405, United States
GSK Investigational Site
Longmont, Colorado, 80501, United States
GSK Investigational Site
Marietta, Georgia, 30062, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Woodstock, Georgia, 30189, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Lexington, Kentucky, 40509, United States
GSK Investigational Site
Nicholasville, Kentucky, 40356, United States
GSK Investigational Site
Columbia, Maryland, 21045, United States
GSK Investigational Site
Stevensville, Michigan, 49127, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Albany, Oregon, 97322, United States
GSK Investigational Site
Carnegie, Pennsylvania, 15106, United States
GSK Investigational Site
Erie, Pennsylvania, 16501, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Hermitage, Pennsylvania, 16148, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4, Canada
GSK Investigational Site
Surrey, British Columbia, V3R 8P8, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3A 1M3, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Woodstock, Ontario, N4S 5P5, Canada
Related Publications (1)
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.
PMID: 24567843DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2010
First Posted
July 19, 2010
Study Start
August 19, 2010
Primary Completion
February 25, 2011
Study Completion
July 29, 2011
Last Updated
June 26, 2018
Results First Posted
June 8, 2017
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.