Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects (1-10 Years of Age)
6 other identifiers
interventional
613
1 country
11
Brief Summary
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination. Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2007
Shorter than P25 for phase_2
11 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
January 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 29, 2007
CompletedStudy Start
First participant enrolled
February 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2007
CompletedResults Posted
Study results publicly available
June 4, 2018
CompletedJune 4, 2018
May 1, 2018
10 months
January 26, 2007
May 4, 2017
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response
Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32 * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.
One Month after vaccination
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Prior to (PRE) vaccination
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Prior to (PRE) to vaccination
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
One month after vaccination [PI(M1)]
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
One month after vaccination [PI(M1)]
Secondary Outcomes (76)
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Prior to (PRE) and one month after vaccination [PI(M1)]
rSBA Antibody Titers
Prior to (PRE) and one month after vaccination [PI(M1)]
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values
Prior to (PRE) and one month after vaccination [PI(M1)]
rSBA Antibody Titers
Prior to (PRE) and one month post vaccination [PI(M1)]
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Prior to (PRE) and one month after vaccination [PI(M1)]
- +71 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALAll subjects received GSK Biolgicals' meningococcal vaccine 134612.
Group B
ACTIVE COMPARATORSubjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.
- A male or female between, and including, 1 through 10 years of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.
You may not qualify if:
- For the primary phase:
- 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 vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
- Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.
- History of meningococcal disease due to serogroup A, C, W, or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (11)
GSK Investigational Site
Espoo, 02100, Finland
GSK Investigational Site
Helsinki, 00100, Finland
GSK Investigational Site
Helsinki, 00930, Finland
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Lahti, 15140, Finland
GSK Investigational Site
Oulu, 90100, Finland
GSK Investigational Site
Pori, 28100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Vantaa, 01300, Finland
GSK Investigational Site
Vantaa, 01600, Finland
Related Publications (2)
Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 years. Hum Vaccin Immunother. 2012 Dec 1;8(12):1882-91. doi: 10.4161/hv.22165. Epub 2012 Oct 2.
PMID: 23032168BACKGROUNDVesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers. Hum Vaccin Immunother. 2012 Dec 1;8(12):1892-903. doi: 10.4161/hv.22166. Epub 2012 Oct 2.
PMID: 23032159BACKGROUND
Related Links
MeSH Terms
Conditions
Condition 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
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2007
First Posted
January 29, 2007
Study Start
February 7, 2007
Primary Completion
December 3, 2007
Study Completion
December 3, 2007
Last Updated
June 4, 2018
Results First Posted
June 4, 2018
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.