The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.
Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (\< 11 years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time the study begun, Menactra® was only licensed in the United States for individuals above 11 years of age and therefore could not be used as a control vaccine in subjects less than 11 years old). This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to \< 11 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
873
Single dose intramuscular injection.
Single dose intramuscular injection.
GSK Investigational Site
Daly City, California, United States
GSK Investigational Site
Fairfield, California, United States
GSK Investigational Site
Redwood City, California, United States
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Time frame: At Day 0 (PRE)
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Time frame: At Month 1
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: At Day 0 (PRE) and Month 1
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: At Day 0 (PRE) and Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Vallejo, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Honolulu, Hawaii, United States
GSK Investigational Site
Honolulu, Hawaii, United States
GSK Investigational Site
Waianae, Hawaii, United States
GSK Investigational Site
Waipio, Hawaii, United States
Assessed solicited general symptoms were fatigue, fever \[defined as orally temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
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.
Time frame: During the 31-day (Days 0-30) follow-up period after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 to Month 6
Number of Subjects With New Onset Chronic Illness(es) (NOCI)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Day 0 to Month 6
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From Day 0 to Month 6
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: From Day 0 to Month 6