The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination. This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
156
Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm
GSK Investigational Site
Garran, Australian Capital Territory, Australia
GSK Investigational Site
Randwick, New South Wales, Australia
GSK Investigational Site
Westmead, New South Wales, Australia
GSK Investigational Site
Herston, Queensland, Australia
GSK Investigational Site
Sherwood, Queensland, Australia
GSK Investigational Site
North Adelaide, South Australia, Australia
GSK Investigational Site
Carlton, Victoria, Australia
GSK Investigational Site
Subiaco, Western Australia, Australia
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At Month 73, one month post-booster vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.
Time frame: At Month 73, one month post-booster vaccination
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 73, one month post-booster vaccination
Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values
The cut-off values for anti-T concentrations were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Time frame: At Month 73, one month post-booster vaccination
Antibody Concentrations Against Tetanus (Anti-T) Antigen
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: At Month 73, one month post-booster vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.
Time frame: At Month 96, 24 months post-booster vaccination
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 96, 24 months post-booster vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
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) post-booster vaccination period at Month 72
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: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
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 Month 72 up to study end, at Month 96
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