Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives \& outcome measures of both the primary \& extension phases.
All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
500
One intramuscular dose.
One subcutaneous dose.
GSK Investigational Site
City of Muntinlupa, Philippines
GSK Investigational Site
Manila, Philippines
GSK Investigational Site
Riyadh, Saudi Arabia
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)
Response to vaccine antigen was defined as: for initially seronegative subjects \[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
Time frame: One month post vaccination
Occurrence of Any Grade 3 Systemic Symptoms
Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \>39.5 °C.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128.
Time frame: Prior to and 1 Month after vaccination
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: Prior to and 1 Month after vaccination
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time frame: Prior to and 1 Month after vaccination
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).
Time frame: Prior to and 1 Month after vaccination
Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time frame: Prior to and 1 Month after vaccination
Concentration of Anti-TT Antibodies
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time frame: Prior to and 1 Month after vaccination
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 1
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 1
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 2
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 2
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 3
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 3
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 4
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 4
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 5
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 5
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Time frame: At Year 1
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time frame: At Year 1
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Time frame: At Year 2
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time frame: At Year 2
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time frame: At Year 3
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time frame: At Year 3
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, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], 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) post-vaccination period
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Day 0 up to 6 Months after vaccination
Number of Subjects With Rash
Time frame: From Day 0 up to 6 Months after vaccination
Number of Subjects With AEs Resulting in Emergency Rooms Visits
Time frame: From Day 0 up to 6 Months after vaccination
Number of Subjects With Unsolicited 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Up to 31 Days after vaccination
Number of Subjects With 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 Day 0 up to 6 Months after vaccination
Number of Subjects With 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: At Year 1, Year 2, Year 3, Year 4 and Year 5
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