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

Phase 3

Completed

Conditions: Infections, Meningococcal

Interventions: Biological: GSK Biologicals' meningococcal vaccine GSK134612
Biological: Menjugate

Registration Number: NCT00674583

Lead Sponsor: GlaxoSmithKline

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 414

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nimenrix Group	GSK Biologicals' meningococcal vaccine GSK134612	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.
Menjugate Group	Menjugate	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody	One month after vaccination (Month 1)	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.

Secondary Outcome Measures

Name	Time	Method
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup	Prior to (Month 0) and one month after vaccination (Month 1)	Antibody titers were presented as geometric mean titers (GMTs).
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms	During the 4-day (Days 0-3) post-vaccination period	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
Number of Subjects Reporting Specific Adverse Events	Up to 6 months after vaccination (Month 6)	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.
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms	During the 4-day (Days 0-3) post-vaccination period	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
Number of Subjects With Any Unsolicited Adverse Events (AEs)	During the 31-day (Days 0-30) post-vaccination period	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.
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms	During the 4-day (Days 0-3) post-vaccination period	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).
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations	Prior to (Month 0) and one month after vaccination (Month 1)	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).
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms	During the 4-day (Days 0-3) post-vaccination period	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).
Number of Subjects With Any Serious Adverse Events (SAEs)	Up to six months after vaccination (Month 6)	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.