Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
Non-inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals' Twinrix™ Versus 134612 Alone and Twinrix™ Alone in Healthy Subjects Aged 11 Through 17 Years.
1 other identifier
interventional
611
2 countries
6
Brief Summary
This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2007
Shorter than P25 for phase_3
6 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
Study Start
First participant enrolled
April 11, 2007
CompletedFirst Submitted
Initial submission to the registry
April 24, 2007
CompletedFirst Posted
Study publicly available on registry
April 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2008
CompletedResults Posted
Study results publicly available
May 22, 2012
CompletedJune 8, 2018
November 1, 2016
1 year
April 24, 2007
April 23, 2012
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
The rSBA titers were expressed as geometric mean titers (GMTs).
At 1 month after vaccination with Nimenrix vaccine (Month 1)
Number of Subjects Seroconverted for Hepatitis A
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
At 1 month after the third dose of Twinrix vaccine (Month 7)
Number of Subjects Seroprotected for Hepatitis B
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
At 1 month after the third dose of Twinrix vaccine (Month 7)
Secondary Outcomes (22)
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
At 1 month after vaccination with Nimenrix vaccine (Month 1)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Anti-Tetanus Toxoid (TT) Antibody Concentrations
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
- +17 more secondary outcomes
Study Arms (3)
Nimenrix + Twinrix Group
EXPERIMENTALSubjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Nimenrix Group
ACTIVE COMPARATORSubjects received 1 dose of Nimenrix™ vaccine at Month 0.
Twinrix Group
ACTIVE COMPARATORSubjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Interventions
Single dose intramuscular injection
3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol
- A male or female between, and including, 11 and 17 years of age at the time of the first dose of vaccine.
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her/the parents'/guardians' knowledge.
- If the subject is female and of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
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 first 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 first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
- Previous vaccination with tetanus toxoid within the last month.
- Previous vaccination with hepatitis A and/or hepatitis B vaccine.
- Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening.
- History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.
- Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) 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 reactions or allergic disease likely to be exacerbated by any component of either vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (6)
GSK Investigational Site
Aarhus N, 8200, Denmark
GSK Investigational Site
Karlskrona, SE-371 41, Sweden
GSK Investigational Site
Linköping, SE-581 85, Sweden
GSK Investigational Site
Malmo, SE-205 02, Sweden
GSK Investigational Site
Örebro, SE-701 16, Sweden
GSK Investigational Site
Umeå, SE-901 85, Sweden
Related Publications (2)
Ostergaard L, Silfverdal SA, Berglund J, Flodmark CE, West C, Bianco V, Baine Y, Miller JM. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix((R)) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 2012 Jan 17;30(4):774-83. doi: 10.1016/j.vaccine.2011.11.051. Epub 2011 Nov 19.
PMID: 22107850BACKGROUNDOstergaard L et al. The Candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugated vaccine (MenACWY-TT) co-administered with a combined hepatitis A and B vaccine (HepA/B) is immunogenic with an acceptable safety profile in subjects aged 11-17 Years. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
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 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2007
First Posted
April 25, 2007
Study Start
April 11, 2007
Primary Completion
April 28, 2008
Study Completion
April 28, 2008
Last Updated
June 8, 2018
Results First Posted
May 22, 2012
Record last verified: 2016-11
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.