Clinical trial NCT00465816: Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: non-inferiority
adolescents
meningococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-25
Enrollment: 611
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
timeFrame: At 1 month after vaccination with Nimenrix vaccine (Month 1)
measure: Number of Subjects Seroconverted for Hepatitis A
timeFrame: At 1 month after the third dose of Twinrix vaccine (Month 7)
measure: Number of Subjects Seroprotected for Hepatitis B
timeFrame: At 1 month after the third dose of Twinrix vaccine (Month 7)
Secondary outcomes:
measure: Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
timeFrame: At 1 month after vaccination with Nimenrix vaccine (Month 1)
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
timeFrame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
measure: Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
timeFrame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
measure: Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
timeFrame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
measure: Anti-Tetanus Toxoid (TT) Antibody Concentrations
timeFrame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
measure: Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
timeFrame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
measure: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
timeFrame: At 7 months after vaccination with Nimenrix (At Month 7)
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
timeFrame: At 7 months after vaccination with Nimenrix (At Month 7)
measure: Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
timeFrame: At 7 months after vaccination with Nimenrix (At Month 7)
measure: Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
timeFrame: At 7 months after vaccination with Nimenrix (At Month 7)
measure: Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
timeFrame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
measure: Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
timeFrame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
measure: IgG Anti-HBs Antibody Concentrations
timeFrame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
measure: Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
timeFrame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
measure: Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
timeFrame: During a 4-day period (Days 0-3) after Nimenrix vaccination
measure: Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
timeFrame: During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses
measure: Number of Subjects Reporting Any Solicited General Symptoms
timeFrame: During a 4-day period (Days 0-3) after each vaccine dose and across doses
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
timeFrame: Up to 1 month after each vaccine dose
measure: Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
timeFrame: During the entire study (up to Month 7)
measure: Number of Subjects Reporting Any Rash
timeFrame: During the entire study (up to Month 7)
measure: Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
timeFrame: During the entire study (up to Month 7)
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: During the entire study (up to Month 7)
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Ostergaard 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.