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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,504
GSK Investigational Site
Goa, India
GSK Investigational Site
Indore, India
GSK Investigational Site
New Delhi, India
GSK Investigational Site
Vellore, India
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).
Time frame: 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.
Time frame: During the 4-day (Days 0-3) post-vaccination period
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.
Time frame: 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).
Time frame: 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.
Time frame: 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)
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GSK Investigational Site
Beirut, Lebanon
GSK Investigational Site
Sampaloc, Manila, Philippines
GSK Investigational Site
Riyadh, Saudi Arabia
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 0 up to 6 months after vaccination