In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology. These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for serogroup C, and a recent publication suggest the same may be true for other serogroups. This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory immune response for the serogroups it contains across subjects 4.5 through 34 years of age who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30 years. A non-randomised age-strata matched group of subjects, who have not previously received (or not received within the preceding 10 years) any meningococcal vaccine, will also be administered the GSK134612 vaccine for comparison.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
271
one dose, as intramuscular injection
GSK Investigational Site
Beirut, Lebanon
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Time frame: One month post-vaccination (Month 1)
Meningococcal rSBA Titers
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Time frame: Prior to vaccination (Day 0)
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs).
Time frame: Prior to (Day 0) and one month post-vaccination (Month 1)
Anti-tetanus Toxoid Antibody Concentrations
Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs).
Time frame: Prior to (Day 0) and one month post-vaccination (Month 1)
Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y
Vaccine response defined as: For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer
Time frame: One month post-vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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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 100 millimeters (mm) of injection site.
Time frame: During the 4-day (Day 0 to Day 3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Day 0 to Day 3) period after vaccination
Number of Subjects With Unsolicited Symptoms
An unsolicited symptom 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 symptom regardless of intensity grade or relation to vaccination.
Time frame: Up to one month post-vaccination (Month 1)
Number of Subjects Reporting Any Serious Adverse Events
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: Day 0 to study month 6
Number of Subjects With Any Specific Adverse Events
Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease). Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately.
Time frame: Day 0 to study month 6