The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,013
One intramuscular injection
One intramuscular injection
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
Vaccine response was defined as: * for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; * for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
Time frame: One month after vaccination (Month 1)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE) and one month after vaccination (Month 1)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.
Time frame: Prior to (PRE) and one month after vaccination (Month 1)
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE) and one month after vaccination (Month 1)
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response was defined as: -for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
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GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Paramount, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Santa Rosa, California, United States
GSK Investigational Site
Longmont, Colorado, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Woodstock, Georgia, United States
GSK Investigational Site
Wichita, Kansas, United States
...and 22 more locations
Time frame: One month after vaccination (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) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. 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) 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: Within 31 days (Day 0-30) post-vaccination
Number of Subjects With New Onset of Chronic Illness(es) (NOCI)
NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity.
Time frame: From Month 0 through Month 6
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 or result in disability/incapacity.
Time frame: From Month 0 through Month 6