Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description
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Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.

Official Title
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Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age

Conditions
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Infections, Meningococcal, Meningococcal Vaccines

Intervention / Treatment
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* Biological: Nimenrix
* Biological: Mencevax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol. A male or female between, and including, 2 and 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. 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 (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 serogroups A, C, W-135 and/or Y. Previous vaccination with tetanus toxoid within the last month. History of meningococcal disease. Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.. History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s). 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 first dose of study vaccine or planned administration during the study period.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimenrix Group<br>Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | Biological: Nimenrix<br>* Single dose, intramuscular injection<br>* Other names: Meningococcal vaccine GSK134612;|
| Active Comparator: Mencevax ACWY Group<br>Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. | Biological: Mencevax<br>* Single dose, subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8). | One month after vaccination (Post-vaccination, study Month 1) | 
| Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | Grade 3 symptom was defined as symptom that prevented normal, everyday activities. | During the 4-day (Days 0-3) post-vaccination period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. | Pre vaccination (Month 0) and post vaccination (Month 1) | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were expressed as geometric mean titers (GMTs). | Pre vaccination (Month 0) and post vaccination (Month 1) | 
| Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively. | Pre vaccination (Month 0) and post vaccination (Month 1) | 
| Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Antibody concentrations were expressed as geometric mean concentrations (GMCs) | Pre vaccination (Month 0) and post vaccination (Month 1) | 
| Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. | Pre vaccination (Month 0) and post vaccination, (Month 1) | 
| Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. | Pre vaccination (Month 0) and post vaccination (Month 1) | 
| Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after vaccination | 
| Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after vaccination | 
| Number of Subjects < 6 Years of Age With Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. | During the 4-day (Days 0-3) follow-up period after vaccination | 
| Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. | During the 4-day (Days 0-3) follow-up period after vaccination | 
| Number of Subjects Reporting Specific Adverse Events (AEs) | Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits. | From Day 0 up to 6 months after vaccination | 
| Number of Subjects Reporting Any Unsolicited Symptoms | Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Up to one month (Day 0-Day 30) after vaccination | 
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject. | From Day 0 up to 6 months after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, meningococcal vaccine, immunogenicity