Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.
Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.
1 other identifier
interventional
873
1 country
10
Brief Summary
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2007
Shorter than P25 for phase_2
10 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
March 30, 2007
CompletedFirst Posted
Study publicly available on registry
April 2, 2007
CompletedStudy Start
First participant enrolled
April 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2008
CompletedResults Posted
Study results publicly available
April 12, 2017
CompletedJune 8, 2018
April 1, 2017
6 months
March 30, 2007
March 1, 2017
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
At Day 0 (PRE)
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
At Month 1
Secondary Outcomes (9)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
At Day 0 (PRE) and Month 1
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
At Day 0 (PRE) and Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
During the 31-day (Days 0-30) follow-up period after vaccination
- +4 more secondary outcomes
Study Arms (3)
Group A
EXPERIMENTALSubjects aged 10 years (\< 11 years) vaccinated with meningococcal vaccine GSK134612.
Group B
EXPERIMENTALSubjects aged 11 to 25 years vaccinated with meningococcal vaccine GSK134612.
Group C
ACTIVE COMPARATORSubjects aged 11 to 25 years vaccinated with Menactra®.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects whom the investigator believes can and will comply with the requirements of the protocol.
- A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination.
- Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.
You may not qualify if:
- Use of any investigational or non-registered product (drug or vaccine) 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 the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
- Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y.
- Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month).
- History of meningococcal disease due to serogroup A, C, W-135, or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Previous history of Guillain-Barré Syndrome.
- Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
- Acute disease at the time of enrollment.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (10)
GSK Investigational Site
Daly City, California, 94015, United States
GSK Investigational Site
Fairfield, California, 94533, United States
GSK Investigational Site
Redwood City, California, 94063, United States
GSK Investigational Site
Sacramento, California, 95815, United States
GSK Investigational Site
Vallejo, California, 94589, United States
GSK Investigational Site
Walnut Creek, California, 94596, United States
GSK Investigational Site
Honolulu, Hawaii, 96814, United States
GSK Investigational Site
Honolulu, Hawaii, 96819, United States
GSK Investigational Site
Waianae, Hawaii, 96792, United States
GSK Investigational Site
Waipio, Hawaii, 96797, United States
Related Publications (2)
Baxter R, Baine Y, Ensor K, Bianco V, Friedland LR, Miller JM. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age. Pediatr Infect Dis J. 2011 Mar;30(3):e41-8. doi: 10.1097/INF.0b013e3182054ab9.
PMID: 21200360BACKGROUNDBaxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
BACKGROUND
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
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2007
First Posted
April 2, 2007
Study Start
April 23, 2007
Primary Completion
October 31, 2007
Study Completion
April 11, 2008
Last Updated
June 8, 2018
Results First Posted
April 12, 2017
Record last verified: 2017-04
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.