The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation. The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens. Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
461
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
GSK Investigational Site
Eferding, Austria
GSK Investigational Site
Graz, Austria
GSK Investigational Site
Salzburg, Austria
Number of Subjects With an Immune Response to Different Meningococcal Serogroups
A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers \< 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
Time frame: One month after the first vaccine dose (Month 1)
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Time frame: Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
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One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
GSK Investigational Site
Vienna, Austria
GSK Investigational Site
Villach, Austria
GSK Investigational Site
Wels, Austria
GSK Investigational Site
Athens, Greece
GSK Investigational Site
Heraklion, Crete, Greece
GSK Investigational Site
Ioannina, Greece
GSK Investigational Site
Komotini, Greece
...and 7 more locations
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Anti-tetanus (Anti-T)
A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Antibody Concentrations Against Tetanus (Anti-T)
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Toddlers With Any Solicited Local Symptoms
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Children With Any Solicited Local Symptoms
The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Toddlers With Any Solicited General Symptoms
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Children With Any Solicited General Symptoms
The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: At one month (M1) and 12 months (M12) post primary vaccination
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups
A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period following booster dose
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time frame: During the 8-day (Days 0-7) post-vaccination period following booster dose
Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination
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 (Days 0-30) after the primary meningococcal vaccination
Number of Subjects With Any Unsolicited AEs During the Primary Vaccination
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 (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
Number of Subjects With Any 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.
Time frame: Within 31 days (Days 0-30) after the booster 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: During the primary vaccination study (from Month 0 up to Month 2)
Number of Subjects With 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: Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)