Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.

Detailed Description
-----------------
The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.

Official Title
-----------------
Non-inferiority of GSK Biologicals' Meningococcal Vaccine (GSK134612) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children

Conditions
-----------------
Infections, Meningococcal

Intervention / Treatment
-----------------
* Biological: GSK Biologicals' meningococcal vaccine GSK134612
* Biological: Menjugate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects whose parents/guardians, the investigator believes 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 the vaccination. Written informed consent obtained from the parent(s) 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 vaccines within 30 days preceding the study vaccine dose, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.. Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after. Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. 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 years (for subjects 6 years old and above). Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y. History of meningococcal disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, 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 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 study vaccine dose or planned administration during the study period. Exclusion criteria for specified regions in France Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135, or Subjects living in a geographic area in France where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | Biological: GSK Biologicals' meningococcal vaccine GSK134612<br>* Intramuscular administration, 1 dose<br>|
| Active Comparator: Menjugate Group<br>Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. | Biological: Menjugate<br>* Intramuscular administration, 1 dose<br>* Other names: MenC-CRM197vaccine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody | Vaccine response to MenC was defined as: -for initially seronegative subjects [i.e. rSBA-MenC titer below (<) 1:8], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer. | One month after vaccination (Month 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | Antibody titers were presented as geometric mean titers (GMTs). | Prior to (Month 0) and one month after vaccination (Month 1) | 
| Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL). | Prior to (Month 0) and one month after vaccination (Month 1) | 
| Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 30 millimeters (mm). | During the 4-day (Days 0-3) post-vaccination period | 
| Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 50 millimeters (mm). | During the 4-day (Days 0-3) post-vaccination period | 
| Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination | During the 4-day (Days 0-3) post-vaccination period | 
| Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination | During the 4-day (Days 0-3) post-vaccination period | 
| Number of Subjects Reporting Specific Adverse Events | Specific AEs included: - rash (hives, idiopathic thrombocytopenic purpura, petechiae); - new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies); - conditions prompting emergency room (ER) visits. | Up to 6 months after vaccination (Month 6) | 
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-vaccination period | 
| Number of Subjects With 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. | Up to six months after vaccination (Month 6) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Conjugate vaccine, Meningococcal disease, Immunogenicity, Meningococcal vaccine, Safety